Opioid Overdose
Conditions
Keywords
Elevated risk, opioid overdose
Brief summary
This prospective, randomized emergency department trial will study the effectiveness of an intervention that combines opioid overdose prevention, education and intervention that includes take home naloxone with brief behavioral change counseling. The study will recruit both heroin users (n=500) and pharmaceutical opioid users at elevated risk for overdose (n=500). Outcomes of interest include subsequent opioid overdoses and overdose risk behaviors. Primary Aims The primary aims are to test whether those who receive the intervention compared to standard care have: 1) Lower rates of opioid non-fatal and fatal overdose; 2) Reduce drug use, inappropriate medication use, and other overdose risk behaviors. Secondary Aims The secondary aims are to test whether those who receive the intervention compared to standard care have: 3) More appropriate health care utilization (e.g. fewer emergency department visits and admissions to inpatient care); 4) Lower total health care costs; 5) Determine the prevalence of HIV risk behaviors among heroin and pharmaceutical opioid users at risk for overdose and whether the intervention impacts these behaviors.
Detailed description
Fatal overdoses involving pharmaceutical opioids have increased dramatically over the past decade, surpassing those related to heroin, and are the leading cause of drug overdose in much of the U.S. In Seattle-King County, 75% of drug overdoses involved pharmaceutical opioids and/or heroin in 2009. Opioid overdoses, heroin and pharmaceutical, are preventable and reversible. Research indicates that drug users and their partners can be successfully trained to recognize and reverse overdoses with naloxone (an opioid antagonist medicine or antidote). Despite active heroin overdose prevention, education and intervention programs with naloxone (OOPEN) in 15 states with thousands of overdose reversals and no serious adverse events, rigorous studies of these programs on rates of subsequent heroin overdoses have not been conducted. No OOPEN programs or studies have yet been implemented for pharmaceutical opioid users at elevated risk for overdose. The Emergency Department (ED) setting holds great promise for identifying and recruiting those at elevated risk of both heroin and pharmaceutical opioid overdose: 1) the ED study site for this proposal provides most services to those needing care for acute opioid related medical problems in Seattle, and 2) patients' need for urgent medical attention may heighten their concern about potential harms from opioids. Unique to this setting is the potential to identify high risk pharmaceutical opioid users, a population that is difficult to locate and engage. ED interventions using brief behavior change counseling (BBCC) have been shown to significantly improve health behaviors such as alcohol use and injury, to increase entry into drug treatment as well as to reduce costs. Evidence is promising, but limited, regarding the impact of BBCC on opioid related risk behaviors. This prospective, randomized ED trial will study the effectiveness of an intervention that combines OOPEN with BBCC for both heroin users (n=500) and pharmaceutical opioid users at elevated risk for overdose (n=500). The primary outcome is subsequent opioid overdoses, ascertained by follow up interviews conducted at 3, 6 and 12 months as well as via administrative records for up to 24 months (i.e. medical records, ambulance responses, and death certificates). Primary Aims The primary aims are to test whether those who receive the intervention compared to standard care have: 1) Lower rates of opioid non-fatal and fatal overdose; 2) Reduce drug use, inappropriate medication use, and other overdose risk behaviors. Secondary Aims The secondary aims are to test whether those who receive the intervention compared to standard care have: 3) More appropriate health care utilization (e.g. fewer emergency department visits and admissions to inpatient care); 4) Lower total health care costs; 5) Determine the prevalence of HIV risk behaviors among heroin and pharmaceutical opioid users at risk for overdose and whether the intervention impacts these behaviors.
Interventions
DRUGOOPEN+BBCC
Take-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose.
Sponsors
National Institute on Drug Abuse (NIDA)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Meets study definition of elevated risk of future opioid overdose * Reason for visit is opioid overdose (regardless of frequency of use), or * Use of pharmaceutical opioids not prescribed to the patient 2 or more times in the prior month, or * Use of other opioids, alcohol, benzodiazepines or stimulants within two hours of using opioids 2 or more times in the prior month, or * Average daily dose of prescribed opioids consumed is greater than10 mg morphine equivalent analgesic dose or higher for 15 or more days in the last 30. * Enrolled in opioid substitution program (e.g. methadone or suboxone) and receiving doses. * Use of heroin through any route of administration at least 2 times in the last 30 days (or if institutionalized recently, in the most recent month they were not institutionalized) with or without other risks being present. * Use of pharmaceutical opioids at least 2 times in the last 30 days (or if institutionalized recently, in the most recent month they were not institutionalized) with other risks being present. * Average daily dose of prescribed opioids consumed is 30 mg morphine equivalent analgesic dose or higher without other risks being present.(For adult medicine clinic patients only.)
Exclusion criteria
* Unwilling to allow further access to medical or drug treatment records. * Inability to communicate in English. * Current active suicidal ideation. * Significant cognitive or psychiatric impairment (per judgment of clinical staff) * Inability to provide adequate contact information to assist with follow-up. * Under age 18 or over age 70 at time of recruitment. * Not currently living in Washington State or planning to move from Washington State within the following year. * Receiving treatment for sexual assault. * Have non-expired take-home naloxone at home, on their person, or in their possessions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Fatal Opioid Overdose | One year | Rate of fatal opioid overdose |
| Rate of Non-fatal Opioid Overdose | One year | Rate of non-fatal opioid overdose |
| Elapsed Time Until Opioid Overdose | Up to1064 days | Elapsed time until opioid overdose |
| Change in Overdose Risk (Change in Opioid Use - Heroin) | 3 months | Determine whether changes in behavior occur that increase or decrease risk of future overdose. Behaviors being measured include the amount of opioids taken, the use of opioids alone, use of opioids with alcohol or other drugs or medications, possessing naloxone, use of opioids in an environment that supports continued opioid use.(Data table includes proportions at 3 month follow-up.) |
| Change in Overdose Risk (Change in Opioid Use - Prescription-Type Opioids) | 3 months | Determine whether changes in behavior occur that increase or decrease risk of future overdose. Behaviors being measured include the amount of opioids taken, the use of opioids alone, use of opioids with alcohol or other drugs or medications, possessing naloxone, use of opioids in an environment that supports continued opioid use.(Data table includes proportions at 3 month follow-up.) |
| Change in Overdose Risk (Using Alone When Taking Opioids) | 3 months | Determine whether changes in behavior occur that increase or decrease risk of future overdose. Behaviors being measured include the amount of opioids taken, the use of opioids alone, use of opioids with alcohol or other drugs or medications, possessing naloxone, use of opioids in an environment that supports continued opioid use. (Data table includes means at 3 month follow-up.) |
| Change in Overdose Risk (Use of Sedatives When Taking Opioids) | 3 months | Determine whether changes in behavior occur that increase or decrease risk of future overdose. Behaviors being measured include the amount of opioids taken, the use of opioids alone, use of opioids with alcohol or other drugs or medications, possessing naloxone, use of opioids in an environment that supports continued opioid use. (Data table includes proportions at 3 month follow-up.) |
| Change in Overdose Risk (Use of Alcohol When Taking Opioids) | 3 months | Determine whether changes in behavior occur that increase or decrease risk of future overdose. Behaviors being measured include the amount of opioids taken, the use of opioids alone, use of opioids with alcohol or other drugs or medications, possessing naloxone, use of opioids in an environment that supports continued opioid use.(Data table includes proportions at 3 month follow-up.) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Heroin) | 3 months | Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.) |
| Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Prescription Type Opioids) | 3 months | Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.) |
| Sub-group Analyses - Change in Overdose Risk (Using Alone When Taking Opioids) | 3 months | Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes means at 3 month follow-up.) |
| Subgroup Analyses- Change in Overdose Risk (Use of Sedatives When Taking Opioids) | 3 months | Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.) |
| Subgroup Analyses- Change in Overdose Risk (Use of Alcohol When Taking Opioids) | 3 months | Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.) |
| Health Care Utilization (ED and Inpatient Admissions) | One year (annual rate) | Appropriate health care utilization (e.g. fewer emergency department visits and admissions to inpatient care) |
| Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) | 3 Months | Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.) |
| Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) | 3 Months | Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.) |
| Health Care Costs | Two years | Total health care costs |
| Health Care Utilization | Two years | Rate and elapsed time until initiation of buprenorphine or methadone maintenance. (for those not on treatment medications) |
| Opioid Overdose - Crossover Analysis | Two years | Crossover analysis- Comparison group participants who obtain naloxone during the follow up period will be analyzed with those in the intervention arm and compared with those who did not obtain naloxone in the comparison arm to examine differences in overdose rates and elapsed time to overdose. |
| Sub-group Analyses - Change in Overdose Risk Behaviors and Perceptions (Take Home Naloxone) | 3 Months | Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.) |
| Change in HIV Risk Behaviors (Condom Use) | 3 months | Determine whether change occurs in the number of sexual risk behaviors (such as engaging in intercourse without a condom) and/or injection use behaviors (such as sharing syringes) that may increase the risk of contracting HIV.(Data table includes proportions at 3 month follow-up.) |
| Change in HIV Risk Behaviors (Shared Syringes) | 3 months | Determine whether change occurs in the number of sexual risk behaviors (such as engaging in intercourse without a condom) and/or injection use behaviors (such as sharing syringes) that may increase the risk of contracting HIV. (Data table includes proportions at 3 month follow-up.) |
| Change in Overdose Risk Behaviors and Perceptions (Take Home Naloxone) | 3 Months | Change in overdose response including naloxone availability and change in overdose risk perceptions. (Data table includes proportions at 3 month follow-up.) |
| Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) | 3 Months | Change in overdose response including naloxone availability and change in overdose risk perceptions. (Data table includes proportions at 3 month follow-up.) |
| Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) | 3 Months | Change in overdose response including naloxone availability and change in overdose risk perceptions. (Data table includes proportions at 3 month follow-up.) |
| Subgroup Analyses - Change in HIV Risk Behaviors (Condom Use) | 3 months | Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.) |
| Subgroup Analyses - Change in HIV Risk Behaviors (Shared Syringes) | 3 months | Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention (OOPEN+BBCC) Study intervention, overdose prevention, education, intervention, brief behavioral change counseling, take-home naloxone, referral to local available resources.
OOPEN+BBCC: Take-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose. | 115 |
| Control Standard of care, referral to local available resources. | 126 |
| Total | 241 |
Baseline characteristics
| Characteristic | Intervention (OOPEN+BBCC) | Control | Total |
|---|---|---|---|
| Age, Continuous | 40.2 years STANDARD_DEVIATION 11.5 | 42.3 years STANDARD_DEVIATION 11.5 | 41.3 years STANDARD_DEVIATION 11.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 21 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 101 Participants | 105 Participants | 206 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Opioid overdose past 3 months | 19 Participants | 27 Participants | 46 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 6 Participants | 6 Participants | 12 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants | 14 Participants | 31 Participants |
| Race (NIH/OMB) More than one race | 18 Participants | 19 Participants | 37 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 14 Participants | 16 Participants | 30 Participants |
| Race (NIH/OMB) White | 60 Participants | 67 Participants | 127 Participants |
| Region of Enrollment United States | 115 participants | 126 participants | 241 participants |
| Sex: Female, Male Female | 32 Participants | 37 Participants | 69 Participants |
| Sex: Female, Male Male | 83 Participants | 89 Participants | 172 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 10 / 115 | 13 / 126 |
| other Total, other adverse events | 0 / 115 | 0 / 126 |
| serious Total, serious adverse events | 0 / 115 | 0 / 126 |
Outcome results
Primary
Change in Overdose Risk (Change in Opioid Use - Heroin)
Determine whether changes in behavior occur that increase or decrease risk of future overdose. Behaviors being measured include the amount of opioids taken, the use of opioids alone, use of opioids with alcohol or other drugs or medications, possessing naloxone, use of opioids in an environment that supports continued opioid use.(Data table includes proportions at 3 month follow-up.)
Time frame: 3 months
Population: Participants reporting change in heroin use: Compared to the last time you spoke with research staff 3 months ago, do you use heroin...
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention (OOPEN+BBCC) | Change in Overdose Risk (Change in Opioid Use - Heroin) | Less | 14 Participants |
| Intervention (OOPEN+BBCC) | Change in Overdose Risk (Change in Opioid Use - Heroin) | Don't Know | 3 Participants |
| Intervention (OOPEN+BBCC) | Change in Overdose Risk (Change in Opioid Use - Heroin) | Same Amount | 7 Participants |
| Intervention (OOPEN+BBCC) | Change in Overdose Risk (Change in Opioid Use - Heroin) | N/A (was not using previously) | 0 Participants |
| Intervention (OOPEN+BBCC) | Change in Overdose Risk (Change in Opioid Use - Heroin) | More | 6 Participants |
| Control | Change in Overdose Risk (Change in Opioid Use - Heroin) | N/A (was not using previously) | 0 Participants |
| Control | Change in Overdose Risk (Change in Opioid Use - Heroin) | More | 4 Participants |
| Control | Change in Overdose Risk (Change in Opioid Use - Heroin) | Less | 17 Participants |
| Control | Change in Overdose Risk (Change in Opioid Use - Heroin) | Same Amount | 7 Participants |
| Control | Change in Overdose Risk (Change in Opioid Use - Heroin) | Don't Know | 1 Participants |
Primary
Change in Overdose Risk (Change in Opioid Use - Prescription-Type Opioids)
Determine whether changes in behavior occur that increase or decrease risk of future overdose. Behaviors being measured include the amount of opioids taken, the use of opioids alone, use of opioids with alcohol or other drugs or medications, possessing naloxone, use of opioids in an environment that supports continued opioid use.(Data table includes proportions at 3 month follow-up.)
Time frame: 3 months
Population: Participants reporting change in prescription-type opioid use: Compared to the last time you spoke with research staff 3 months ago, do you use prescription-type medications...
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention (OOPEN+BBCC) | Change in Overdose Risk (Change in Opioid Use - Prescription-Type Opioids) | Less | 12 Participants |
| Intervention (OOPEN+BBCC) | Change in Overdose Risk (Change in Opioid Use - Prescription-Type Opioids) | Don't know Don't Know | 2 Participants |
| Intervention (OOPEN+BBCC) | Change in Overdose Risk (Change in Opioid Use - Prescription-Type Opioids) | Same Amount | 12 Participants |
| Intervention (OOPEN+BBCC) | Change in Overdose Risk (Change in Opioid Use - Prescription-Type Opioids) | N/A (was not using previously) | 2 Participants |
| Intervention (OOPEN+BBCC) | Change in Overdose Risk (Change in Opioid Use - Prescription-Type Opioids) | More | 7 Participants |
| Control | Change in Overdose Risk (Change in Opioid Use - Prescription-Type Opioids) | N/A (was not using previously) | 0 Participants |
| Control | Change in Overdose Risk (Change in Opioid Use - Prescription-Type Opioids) | More | 9 Participants |
| Control | Change in Overdose Risk (Change in Opioid Use - Prescription-Type Opioids) | Less | 11 Participants |
| Control | Change in Overdose Risk (Change in Opioid Use - Prescription-Type Opioids) | Same Amount | 16 Participants |
| Control | Change in Overdose Risk (Change in Opioid Use - Prescription-Type Opioids) | Don't know Don't Know | 3 Participants |
Primary
Change in Overdose Risk (Use of Alcohol When Taking Opioids)
Determine whether changes in behavior occur that increase or decrease risk of future overdose. Behaviors being measured include the amount of opioids taken, the use of opioids alone, use of opioids with alcohol or other drugs or medications, possessing naloxone, use of opioids in an environment that supports continued opioid use.(Data table includes proportions at 3 month follow-up.)
Time frame: 3 months
Population: Use of alcohol when taking opioids, When you use opioids, how often do drink alcohol with 2 hours before or after?
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention (OOPEN+BBCC) | Change in Overdose Risk (Use of Alcohol When Taking Opioids) | Baseline: Always | 8 Participants |
| Intervention (OOPEN+BBCC) | Change in Overdose Risk (Use of Alcohol When Taking Opioids) | Baseline: Never | 86 Participants |
| Intervention (OOPEN+BBCC) | Change in Overdose Risk (Use of Alcohol When Taking Opioids) | Follow-up: Sometimes | 9 Participants |
| Intervention (OOPEN+BBCC) | Change in Overdose Risk (Use of Alcohol When Taking Opioids) | Baseline: Sometimes | 31 Participants |
| Intervention (OOPEN+BBCC) | Change in Overdose Risk (Use of Alcohol When Taking Opioids) | Follow-up: Never | 43 Participants |
| Intervention (OOPEN+BBCC) | Change in Overdose Risk (Use of Alcohol When Taking Opioids) | Follow-up: Always | 5 Participants |
| Control | Change in Overdose Risk (Use of Alcohol When Taking Opioids) | Follow-up: Never | 45 Participants |
| Control | Change in Overdose Risk (Use of Alcohol When Taking Opioids) | Baseline: Never | 77 Participants |
| Control | Change in Overdose Risk (Use of Alcohol When Taking Opioids) | Baseline: Always | 19 Participants |
| Control | Change in Overdose Risk (Use of Alcohol When Taking Opioids) | Baseline: Sometimes | 35 Participants |
| Control | Change in Overdose Risk (Use of Alcohol When Taking Opioids) | Follow-up: Always | 4 Participants |
| Control | Change in Overdose Risk (Use of Alcohol When Taking Opioids) | Follow-up: Sometimes | 9 Participants |
Primary
Change in Overdose Risk (Use of Sedatives When Taking Opioids)
Determine whether changes in behavior occur that increase or decrease risk of future overdose. Behaviors being measured include the amount of opioids taken, the use of opioids alone, use of opioids with alcohol or other drugs or medications, possessing naloxone, use of opioids in an environment that supports continued opioid use. (Data table includes proportions at 3 month follow-up.)
Time frame: 3 months
Population: Use of sedatives when taking opioids, When you use opioids, how often do you use sedatives or downers within 2 hours before or after?~.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention (OOPEN+BBCC) | Change in Overdose Risk (Use of Sedatives When Taking Opioids) | Baseline: Always | 11 Participants |
| Intervention (OOPEN+BBCC) | Change in Overdose Risk (Use of Sedatives When Taking Opioids) | Baseline: Sometimes | 41 Participants |
| Intervention (OOPEN+BBCC) | Change in Overdose Risk (Use of Sedatives When Taking Opioids) | Baseline: Never | 73 Participants |
| Intervention (OOPEN+BBCC) | Change in Overdose Risk (Use of Sedatives When Taking Opioids) | Follow-up: Always | 2 Participants |
| Intervention (OOPEN+BBCC) | Change in Overdose Risk (Use of Sedatives When Taking Opioids) | Follow-up: Sometimes | 15 Participants |
| Intervention (OOPEN+BBCC) | Change in Overdose Risk (Use of Sedatives When Taking Opioids) | Follow-up: Never | 39 Participants |
| Control | Change in Overdose Risk (Use of Sedatives When Taking Opioids) | Follow-up: Sometimes | 11 Participants |
| Control | Change in Overdose Risk (Use of Sedatives When Taking Opioids) | Baseline: Always | 11 Participants |
| Control | Change in Overdose Risk (Use of Sedatives When Taking Opioids) | Follow-up: Always | 2 Participants |
| Control | Change in Overdose Risk (Use of Sedatives When Taking Opioids) | Baseline: Sometimes | 53 Participants |
| Control | Change in Overdose Risk (Use of Sedatives When Taking Opioids) | Follow-up: Never | 45 Participants |
| Control | Change in Overdose Risk (Use of Sedatives When Taking Opioids) | Baseline: Never | 67 Participants |
Primary
Change in Overdose Risk (Using Alone When Taking Opioids)
Determine whether changes in behavior occur that increase or decrease risk of future overdose. Behaviors being measured include the amount of opioids taken, the use of opioids alone, use of opioids with alcohol or other drugs or medications, possessing naloxone, use of opioids in an environment that supports continued opioid use. (Data table includes means at 3 month follow-up.)
Time frame: 3 months
Population: Mean days using opioids alone, among people who used one or more days in the past 30, In the past 30 days, how many days have you used opioids when nobody else was around?
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention (OOPEN+BBCC) | Change in Overdose Risk (Using Alone When Taking Opioids) | Baseline | 17.9 days in the past 30 | Standard Deviation 10.5 |
| Intervention (OOPEN+BBCC) | Change in Overdose Risk (Using Alone When Taking Opioids) | Follow-up | 16.5 days in the past 30 | Standard Deviation 10.9 |
| Control | Change in Overdose Risk (Using Alone When Taking Opioids) | Baseline | 15.6 days in the past 30 | Standard Deviation 10.9 |
| Control | Change in Overdose Risk (Using Alone When Taking Opioids) | Follow-up | 16.7 days in the past 30 | Standard Deviation 10.7 |
Primary
Elapsed Time Until Opioid Overdose
Elapsed time until opioid overdose
Time frame: Up to1064 days
Population: Mean days to first overdose event
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention (OOPEN+BBCC) | Elapsed Time Until Opioid Overdose | 870 days |
| Control | Elapsed Time Until Opioid Overdose | 836 days |
Primary
Rate of Fatal Opioid Overdose
Rate of fatal opioid overdose
Time frame: One year
Population: Number of participants experiencing fatal opioid overdose.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention (OOPEN+BBCC) | Rate of Fatal Opioid Overdose | 2 Participants |
| Control | Rate of Fatal Opioid Overdose | 6 Participants |
Primary
Rate of Non-fatal Opioid Overdose
Rate of non-fatal opioid overdose
Time frame: One year
Population: Number of participants experiencing non-fatal opioid overdose.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention (OOPEN+BBCC) | Rate of Non-fatal Opioid Overdose | 22 Participants |
| Control | Rate of Non-fatal Opioid Overdose | 27 Participants |
Secondary
Change in HIV Risk Behaviors (Condom Use)
Determine whether change occurs in the number of sexual risk behaviors (such as engaging in intercourse without a condom) and/or injection use behaviors (such as sharing syringes) that may increase the risk of contracting HIV.(Data table includes proportions at 3 month follow-up.)
Time frame: 3 months
Population: Frequency of condom use in the past 3 months, In the past three months, how often did you use condoms when you had sex?
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intervention (OOPEN+BBCC) | Change in HIV Risk Behaviors (Condom Use) | Baseline | None of the time | 33 Participants |
| Intervention (OOPEN+BBCC) | Change in HIV Risk Behaviors (Condom Use) | Baseline | All the time | 20 Participants |
| Intervention (OOPEN+BBCC) | Change in HIV Risk Behaviors (Condom Use) | Baseline | Most of the time | 8 Participants |
| Intervention (OOPEN+BBCC) | Change in HIV Risk Behaviors (Condom Use) | Baseline | Some of the time | 8 Participants |
| Intervention (OOPEN+BBCC) | Change in HIV Risk Behaviors (Condom Use) | Baseline | Not applicable/No sex past 3 months | 2 Participants |
| Intervention (OOPEN+BBCC) | Change in HIV Risk Behaviors (Condom Use) | Follow-up | All the time | 12 Participants |
| Intervention (OOPEN+BBCC) | Change in HIV Risk Behaviors (Condom Use) | Follow-up | Most of the time | 0 Participants |
| Intervention (OOPEN+BBCC) | Change in HIV Risk Behaviors (Condom Use) | Follow-up | Some of the time | 3 Participants |
| Intervention (OOPEN+BBCC) | Change in HIV Risk Behaviors (Condom Use) | Follow-up | None of the time | 13 Participants |
| Intervention (OOPEN+BBCC) | Change in HIV Risk Behaviors (Condom Use) | Follow-up | Not applicable/No sex past 3 months | 1 Participants |
| Control | Change in HIV Risk Behaviors (Condom Use) | Follow-up | Some of the time | 1 Participants |
| Control | Change in HIV Risk Behaviors (Condom Use) | Follow-up | All the time | 5 Participants |
| Control | Change in HIV Risk Behaviors (Condom Use) | Baseline | All the time | 14 Participants |
| Control | Change in HIV Risk Behaviors (Condom Use) | Follow-up | Not applicable/No sex past 3 months | 3 Participants |
| Control | Change in HIV Risk Behaviors (Condom Use) | Baseline | Most of the time | 6 Participants |
| Control | Change in HIV Risk Behaviors (Condom Use) | Follow-up | Most of the time | 1 Participants |
| Control | Change in HIV Risk Behaviors (Condom Use) | Baseline | Some of the time | 5 Participants |
| Control | Change in HIV Risk Behaviors (Condom Use) | Baseline | None of the time | 45 Participants |
| Control | Change in HIV Risk Behaviors (Condom Use) | Follow-up | None of the time | 15 Participants |
| Control | Change in HIV Risk Behaviors (Condom Use) | Baseline | Not applicable/No sex past 3 months | 3 Participants |
Secondary
Change in HIV Risk Behaviors (Shared Syringes)
Determine whether change occurs in the number of sexual risk behaviors (such as engaging in intercourse without a condom) and/or injection use behaviors (such as sharing syringes) that may increase the risk of contracting HIV. (Data table includes proportions at 3 month follow-up.)
Time frame: 3 months
Population: Number of participants who shared syringes or injection supplies, In the past three months, have you shared needles or works?
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention (OOPEN+BBCC) | Change in HIV Risk Behaviors (Shared Syringes) | Baseline | 29 Participants |
| Intervention (OOPEN+BBCC) | Change in HIV Risk Behaviors (Shared Syringes) | Follow-up | 11 Participants |
| Control | Change in HIV Risk Behaviors (Shared Syringes) | Baseline | 29 Participants |
| Control | Change in HIV Risk Behaviors (Shared Syringes) | Follow-up | 4 Participants |
Secondary
Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose)
Change in overdose response including naloxone availability and change in overdose risk perceptions. (Data table includes proportions at 3 month follow-up.)
Time frame: 3 Months
Population: Perception of concern about opioid overdose, How concerned are you about YOU experiencing an overdose?
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intervention (OOPEN+BBCC) | Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) | Baseline | Extremely/somewhat concerned | 24 Participants |
| Intervention (OOPEN+BBCC) | Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) | Baseline | Not sure | 1 Participants |
| Intervention (OOPEN+BBCC) | Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) | Baseline | Not very/at all concerned | 39 Participants |
| Intervention (OOPEN+BBCC) | Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) | Follow-up | Extremely/somewhat concerned | 9 Participants |
| Intervention (OOPEN+BBCC) | Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) | Follow-up | Not sure | 2 Participants |
| Intervention (OOPEN+BBCC) | Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) | Follow-up | Not very/at all concerned | 24 Participants |
| Control | Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) | Follow-up | Not sure | 0 Participants |
| Control | Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) | Baseline | Extremely/somewhat concerned | 28 Participants |
| Control | Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) | Follow-up | Extremely/somewhat concerned | 7 Participants |
| Control | Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) | Baseline | Not sure | 3 Participants |
| Control | Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) | Follow-up | Not very/at all concerned | 22 Participants |
| Control | Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) | Baseline | Not very/at all concerned | 32 Participants |
Secondary
Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose)
Change in overdose response including naloxone availability and change in overdose risk perceptions. (Data table includes proportions at 3 month follow-up.)
Time frame: 3 Months
Population: Perception of likelihood of opioid overdose, How likely is it that you will experience an opiate overdose in the next year?
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intervention (OOPEN+BBCC) | Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) | Baseline | Extremely/somewhat likely | 12 Participants |
| Intervention (OOPEN+BBCC) | Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) | Baseline | Not sure | 14 Participants |
| Intervention (OOPEN+BBCC) | Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) | Baseline | Extreme/somewhat unlikely | 38 Participants |
| Intervention (OOPEN+BBCC) | Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) | Follow-up | Extremely/somewhat likely | 1 Participants |
| Intervention (OOPEN+BBCC) | Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) | Follow-up | Not sure | 17 Participants |
| Intervention (OOPEN+BBCC) | Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) | Follow-up | Extreme/somewhat unlikely | 17 Participants |
| Control | Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) | Follow-up | Not sure | 6 Participants |
| Control | Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) | Baseline | Extremely/somewhat likely | 15 Participants |
| Control | Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) | Follow-up | Extremely/somewhat likely | 3 Participants |
| Control | Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) | Baseline | Not sure | 19 Participants |
| Control | Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) | Follow-up | Extreme/somewhat unlikely | 20 Participants |
| Control | Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) | Baseline | Extreme/somewhat unlikely | 29 Participants |
Secondary
Change in Overdose Risk Behaviors and Perceptions (Take Home Naloxone)
Change in overdose response including naloxone availability and change in overdose risk perceptions. (Data table includes proportions at 3 month follow-up.)
Time frame: 3 Months
Population: Number of people with naloxone in the past 3 months, At any time in the past 3 months did you have take-home naloxone?
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention (OOPEN+BBCC) | Change in Overdose Risk Behaviors and Perceptions (Take Home Naloxone) | 41 Participants |
| Control | Change in Overdose Risk Behaviors and Perceptions (Take Home Naloxone) | 10 Participants |
Secondary
Health Care Costs
Total health care costs
Time frame: Two years
Population: Health care cost data were not obtained, therefore these analyses could not be conducted.
Secondary
Health Care Utilization
Rate and elapsed time until initiation of buprenorphine or methadone maintenance. (for those not on treatment medications)
Time frame: Two years
Population: Data for initiation of buprenorphine and methadone for those not on treatment medications were not obtained, therefore these analyses could not be conducted.
Secondary
Health Care Utilization
Retention time on buprenorphine or methadone (for those on medications at baseline)
Time frame: Two years
Population: Retention data for buprenorphine and methadone were not obtained, therefore these analyses could not be conducted.
Secondary
Health Care Utilization (ED and Inpatient Admissions)
Appropriate health care utilization (e.g. fewer emergency department visits and admissions to inpatient care)
Time frame: One year (annual rate)
Population: Annual mean number per person
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention (OOPEN+BBCC) | Health Care Utilization (ED and Inpatient Admissions) | Emergency department visits | 4.96 annual visits |
| Intervention (OOPEN+BBCC) | Health Care Utilization (ED and Inpatient Admissions) | Inpatient admissions | 1.29 annual visits |
| Control | Health Care Utilization (ED and Inpatient Admissions) | Emergency department visits | 4.85 annual visits |
| Control | Health Care Utilization (ED and Inpatient Admissions) | Inpatient admissions | 1.05 annual visits |
Secondary
Opioid Overdose - Crossover Analysis
Crossover analysis- Comparison group participants who obtain naloxone during the follow up period will be analyzed with those in the intervention arm and compared with those who did not obtain naloxone in the comparison arm to examine differences in overdose rates and elapsed time to overdose.
Time frame: Two years
Population: Specific dates when naloxone was obtained were not collected, therefore these analyses could not be conducted.
Secondary
Subgroup Analyses - Change in HIV Risk Behaviors (Condom Use)
Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.)
Time frame: 3 months
Population: Frequency of condom use in the past 3 months by housing status. In the past three months, how often did you use condoms when you had sex?
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention (OOPEN+BBCC) | Subgroup Analyses - Change in HIV Risk Behaviors (Condom Use) | None of the time | 5 Participants |
| Intervention (OOPEN+BBCC) | Subgroup Analyses - Change in HIV Risk Behaviors (Condom Use) | Most of the time | 0 Participants |
| Intervention (OOPEN+BBCC) | Subgroup Analyses - Change in HIV Risk Behaviors (Condom Use) | Not applicable/No sex past 3 months | 0 Participants |
| Intervention (OOPEN+BBCC) | Subgroup Analyses - Change in HIV Risk Behaviors (Condom Use) | Some of the time | 1 Participants |
| Intervention (OOPEN+BBCC) | Subgroup Analyses - Change in HIV Risk Behaviors (Condom Use) | All the time | 4 Participants |
| Control | Subgroup Analyses - Change in HIV Risk Behaviors (Condom Use) | Some of the time | 2 Participants |
| Control | Subgroup Analyses - Change in HIV Risk Behaviors (Condom Use) | None of the time | 8 Participants |
| Control | Subgroup Analyses - Change in HIV Risk Behaviors (Condom Use) | Not applicable/No sex past 3 months | 1 Participants |
| Control | Subgroup Analyses - Change in HIV Risk Behaviors (Condom Use) | Most of the time | 0 Participants |
| Control | Subgroup Analyses - Change in HIV Risk Behaviors (Condom Use) | All the time | 8 Participants |
| Control - Permanent or Stable Housing | Subgroup Analyses - Change in HIV Risk Behaviors (Condom Use) | Some of the time | 1 Participants |
| Control - Permanent or Stable Housing | Subgroup Analyses - Change in HIV Risk Behaviors (Condom Use) | All the time | 2 Participants |
| Control - Permanent or Stable Housing | Subgroup Analyses - Change in HIV Risk Behaviors (Condom Use) | Most of the time | 0 Participants |
| Control - Permanent or Stable Housing | Subgroup Analyses - Change in HIV Risk Behaviors (Condom Use) | None of the time | 8 Participants |
| Control - Permanent or Stable Housing | Subgroup Analyses - Change in HIV Risk Behaviors (Condom Use) | Not applicable/No sex past 3 months | 1 Participants |
| Control - Temporary or Unstable Housing or Unhoused. | Subgroup Analyses - Change in HIV Risk Behaviors (Condom Use) | None of the time | 7 Participants |
| Control - Temporary or Unstable Housing or Unhoused. | Subgroup Analyses - Change in HIV Risk Behaviors (Condom Use) | Most of the time | 1 Participants |
| Control - Temporary or Unstable Housing or Unhoused. | Subgroup Analyses - Change in HIV Risk Behaviors (Condom Use) | All the time | 3 Participants |
| Control - Temporary or Unstable Housing or Unhoused. | Subgroup Analyses - Change in HIV Risk Behaviors (Condom Use) | Some of the time | 0 Participants |
| Control - Temporary or Unstable Housing or Unhoused. | Subgroup Analyses - Change in HIV Risk Behaviors (Condom Use) | Not applicable/No sex past 3 months | 2 Participants |
Secondary
Subgroup Analyses - Change in HIV Risk Behaviors (Shared Syringes)
Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.)
Time frame: 3 months
Population: Number of participants who shared syringes or injection supplies by housing status. In the past three months, have you shared needles or works?
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention (OOPEN+BBCC) | Subgroup Analyses - Change in HIV Risk Behaviors (Shared Syringes) | 4 Participants |
| Control | Subgroup Analyses - Change in HIV Risk Behaviors (Shared Syringes) | 7 Participants |
| Control - Permanent or Stable Housing | Subgroup Analyses - Change in HIV Risk Behaviors (Shared Syringes) | 2 Participants |
| Control - Temporary or Unstable Housing or Unhoused. | Subgroup Analyses - Change in HIV Risk Behaviors (Shared Syringes) | 2 Participants |
Secondary
Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose)
Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.)
Time frame: 3 Months
Population: Perception of concern about opioid overdose by housing status. How concerned are you about YOU experiencing an overdose?
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention (OOPEN+BBCC) | Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) | Not sure | 1 Participants |
| Intervention (OOPEN+BBCC) | Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) | Extremely concerned | 1 Participants |
| Intervention (OOPEN+BBCC) | Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) | Not very concerned | 4 Participants |
| Intervention (OOPEN+BBCC) | Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) | Somewhat concerned | 1 Participants |
| Intervention (OOPEN+BBCC) | Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) | Not concerned at all | 1 Participants |
| Control | Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) | Not sure | 1 Participants |
| Control | Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) | Somewhat concerned | 2 Participants |
| Control | Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) | Not very concerned | 6 Participants |
| Control | Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) | Not concerned at all | 13 Participants |
| Control | Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) | Extremely concerned | 5 Participants |
| Control - Permanent or Stable Housing | Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) | Not concerned at all | 7 Participants |
| Control - Permanent or Stable Housing | Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) | Extremely concerned | 2 Participants |
| Control - Permanent or Stable Housing | Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) | Somewhat concerned | 3 Participants |
| Control - Permanent or Stable Housing | Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) | Not sure | 0 Participants |
| Control - Permanent or Stable Housing | Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) | Not very concerned | 4 Participants |
| Control - Temporary or Unstable Housing or Unhoused. | Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) | Extremely concerned | 1 Participants |
| Control - Temporary or Unstable Housing or Unhoused. | Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) | Not very concerned | 2 Participants |
| Control - Temporary or Unstable Housing or Unhoused. | Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) | Somewhat concerned | 1 Participants |
| Control - Temporary or Unstable Housing or Unhoused. | Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) | Not concerned at all | 9 Participants |
| Control - Temporary or Unstable Housing or Unhoused. | Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Concerned About Overdose) | Not sure | 0 Participants |
Secondary
Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose)
Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.)
Time frame: 3 Months
Population: Perception of likelihood of opioid overdose by housing status. How likely is it that you will experience an opiate overdose in the next year?
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention (OOPEN+BBCC) | Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) | Somewhat unlikely | 3 Participants |
| Intervention (OOPEN+BBCC) | Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) | Somewhat likely | 0 Participants |
| Intervention (OOPEN+BBCC) | Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) | Extremely unlikely | 3 Participants |
| Intervention (OOPEN+BBCC) | Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) | Not sure | 2 Participants |
| Intervention (OOPEN+BBCC) | Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) | Extremely likely | 0 Participants |
| Control | Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) | Not sure | 5 Participants |
| Control | Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) | Somewhat unlikely | 7 Participants |
| Control | Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) | Extremely unlikely | 14 Participants |
| Control | Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) | Somewhat likely | 0 Participants |
| Control | Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) | Extremely likely | 1 Participants |
| Control - Permanent or Stable Housing | Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) | Not sure | 3 Participants |
| Control - Permanent or Stable Housing | Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) | Extremely likely | 0 Participants |
| Control - Permanent or Stable Housing | Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) | Somewhat likely | 2 Participants |
| Control - Permanent or Stable Housing | Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) | Somewhat unlikely | 3 Participants |
| Control - Permanent or Stable Housing | Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) | Extremely unlikely | 8 Participants |
| Control - Temporary or Unstable Housing or Unhoused. | Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) | Somewhat unlikely | 1 Participants |
| Control - Temporary or Unstable Housing or Unhoused. | Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) | Somewhat likely | 1 Participants |
| Control - Temporary or Unstable Housing or Unhoused. | Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) | Extremely likely | 0 Participants |
| Control - Temporary or Unstable Housing or Unhoused. | Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) | Not sure | 3 Participants |
| Control - Temporary or Unstable Housing or Unhoused. | Sub-group Analyses- Change in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose) | Extremely unlikely | 8 Participants |
Secondary
Sub-group Analyses - Change in Overdose Risk Behaviors and Perceptions (Take Home Naloxone)
Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.)
Time frame: 3 Months
Population: Number of people with naloxone in the past 3 months by housing status. At any time in the past 3 months did you have take-home naloxone?
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention (OOPEN+BBCC) | Sub-group Analyses - Change in Overdose Risk Behaviors and Perceptions (Take Home Naloxone) | 11 Participants |
| Control | Sub-group Analyses - Change in Overdose Risk Behaviors and Perceptions (Take Home Naloxone) | 30 Participants |
| Control - Permanent or Stable Housing | Sub-group Analyses - Change in Overdose Risk Behaviors and Perceptions (Take Home Naloxone) | 4 Participants |
| Control - Temporary or Unstable Housing or Unhoused. | Sub-group Analyses - Change in Overdose Risk Behaviors and Perceptions (Take Home Naloxone) | 6 Participants |
Secondary
Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Heroin)
Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.)
Time frame: 3 months
Population: Participants reporting change in heroin use by housing status: Compared to the last time you spoke with research staff 3 months ago, do you use heroin...
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention (OOPEN+BBCC) | Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Heroin) | Don't Know | 1 Participants |
| Intervention (OOPEN+BBCC) | Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Heroin) | Less | 4 Participants |
| Intervention (OOPEN+BBCC) | Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Heroin) | N/A (was not using previously) | 0 Participants |
| Intervention (OOPEN+BBCC) | Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Heroin) | Same Amount | 2 Participants |
| Intervention (OOPEN+BBCC) | Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Heroin) | More | 1 Participants |
| Control | Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Heroin) | Same Amount | 5 Participants |
| Control | Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Heroin) | Don't Know | 2 Participants |
| Control | Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Heroin) | N/A (was not using previously) | 0 Participants |
| Control | Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Heroin) | Less | 10 Participants |
| Control | Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Heroin) | More | 5 Participants |
| Control - Permanent or Stable Housing | Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Heroin) | Same Amount | 3 Participants |
| Control - Permanent or Stable Housing | Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Heroin) | More | 3 Participants |
| Control - Permanent or Stable Housing | Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Heroin) | Less | 6 Participants |
| Control - Permanent or Stable Housing | Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Heroin) | Don't Know | 0 Participants |
| Control - Permanent or Stable Housing | Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Heroin) | N/A (was not using previously) | 0 Participants |
| Control - Temporary or Unstable Housing or Unhoused. | Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Heroin) | Don't Know | 1 Participants |
| Control - Temporary or Unstable Housing or Unhoused. | Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Heroin) | Less | 11 Participants |
| Control - Temporary or Unstable Housing or Unhoused. | Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Heroin) | More | 1 Participants |
| Control - Temporary or Unstable Housing or Unhoused. | Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Heroin) | Same Amount | 4 Participants |
| Control - Temporary or Unstable Housing or Unhoused. | Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Heroin) | N/A (was not using previously) | 0 Participants |
Secondary
Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Prescription Type Opioids)
Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.)
Time frame: 3 months
Population: Participants reporting change in prescription-type opioids by use by housing status: Compared to the last time you spoke with research staff 3 months ago, do you use prescription type opioids...
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention (OOPEN+BBCC) | Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Prescription Type Opioids) | Don't Know | 1 Participants |
| Intervention (OOPEN+BBCC) | Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Prescription Type Opioids) | Less | 3 Participants |
| Intervention (OOPEN+BBCC) | Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Prescription Type Opioids) | N/A (was not using previously) | 0 Participants |
| Intervention (OOPEN+BBCC) | Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Prescription Type Opioids) | Same Amount | 5 Participants |
| Intervention (OOPEN+BBCC) | Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Prescription Type Opioids) | More | 2 Participants |
| Control | Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Prescription Type Opioids) | Same Amount | 7 Participants |
| Control | Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Prescription Type Opioids) | Don't Know | 1 Participants |
| Control | Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Prescription Type Opioids) | N/A (was not using previously) | 2 Participants |
| Control | Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Prescription Type Opioids) | Less | 9 Participants |
| Control | Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Prescription Type Opioids) | More | 5 Participants |
| Control - Permanent or Stable Housing | Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Prescription Type Opioids) | Same Amount | 10 Participants |
| Control - Permanent or Stable Housing | Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Prescription Type Opioids) | More | 6 Participants |
| Control - Permanent or Stable Housing | Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Prescription Type Opioids) | Less | 7 Participants |
| Control - Permanent or Stable Housing | Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Prescription Type Opioids) | Don't Know | 1 Participants |
| Control - Permanent or Stable Housing | Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Prescription Type Opioids) | N/A (was not using previously) | 0 Participants |
| Control - Temporary or Unstable Housing or Unhoused. | Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Prescription Type Opioids) | Don't Know | 2 Participants |
| Control - Temporary or Unstable Housing or Unhoused. | Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Prescription Type Opioids) | Less | 4 Participants |
| Control - Temporary or Unstable Housing or Unhoused. | Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Prescription Type Opioids) | More | 3 Participants |
| Control - Temporary or Unstable Housing or Unhoused. | Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Prescription Type Opioids) | Same Amount | 6 Participants |
| Control - Temporary or Unstable Housing or Unhoused. | Sub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Prescription Type Opioids) | N/A (was not using previously) | 0 Participants |
Secondary
Subgroup Analyses- Change in Overdose Risk (Use of Alcohol When Taking Opioids)
Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.)
Time frame: 3 months
Population: Use of alcohol when taking opioids by housing status When you use opioids, how often do drink alcohol with 2 hours before or after?
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention (OOPEN+BBCC) | Subgroup Analyses- Change in Overdose Risk (Use of Alcohol When Taking Opioids) | Always | 1 Participants |
| Intervention (OOPEN+BBCC) | Subgroup Analyses- Change in Overdose Risk (Use of Alcohol When Taking Opioids) | Never | 16 Participants |
| Intervention (OOPEN+BBCC) | Subgroup Analyses- Change in Overdose Risk (Use of Alcohol When Taking Opioids) | Sometimes | 1 Participants |
| Control | Subgroup Analyses- Change in Overdose Risk (Use of Alcohol When Taking Opioids) | Always | 4 Participants |
| Control | Subgroup Analyses- Change in Overdose Risk (Use of Alcohol When Taking Opioids) | Never | 27 Participants |
| Control | Subgroup Analyses- Change in Overdose Risk (Use of Alcohol When Taking Opioids) | Sometimes | 8 Participants |
| Control - Permanent or Stable Housing | Subgroup Analyses- Change in Overdose Risk (Use of Alcohol When Taking Opioids) | Sometimes | 3 Participants |
| Control - Permanent or Stable Housing | Subgroup Analyses- Change in Overdose Risk (Use of Alcohol When Taking Opioids) | Always | 3 Participants |
| Control - Permanent or Stable Housing | Subgroup Analyses- Change in Overdose Risk (Use of Alcohol When Taking Opioids) | Never | 26 Participants |
| Control - Temporary or Unstable Housing or Unhoused. | Subgroup Analyses- Change in Overdose Risk (Use of Alcohol When Taking Opioids) | Always | 1 Participants |
| Control - Temporary or Unstable Housing or Unhoused. | Subgroup Analyses- Change in Overdose Risk (Use of Alcohol When Taking Opioids) | Never | 19 Participants |
| Control - Temporary or Unstable Housing or Unhoused. | Subgroup Analyses- Change in Overdose Risk (Use of Alcohol When Taking Opioids) | Sometimes | 6 Participants |
Secondary
Subgroup Analyses- Change in Overdose Risk (Use of Sedatives When Taking Opioids)
Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.)
Time frame: 3 months
Population: Use of sedatives when taking opioids by housing status. When you use opioids, how often do you take sedatives or downers with 2 hours before or after?
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention (OOPEN+BBCC) | Subgroup Analyses- Change in Overdose Risk (Use of Sedatives When Taking Opioids) | Always | 1 Participants |
| Intervention (OOPEN+BBCC) | Subgroup Analyses- Change in Overdose Risk (Use of Sedatives When Taking Opioids) | Never | 11 Participants |
| Intervention (OOPEN+BBCC) | Subgroup Analyses- Change in Overdose Risk (Use of Sedatives When Taking Opioids) | Sometimes | 6 Participants |
| Control | Subgroup Analyses- Change in Overdose Risk (Use of Sedatives When Taking Opioids) | Always | 1 Participants |
| Control | Subgroup Analyses- Change in Overdose Risk (Use of Sedatives When Taking Opioids) | Never | 28 Participants |
| Control | Subgroup Analyses- Change in Overdose Risk (Use of Sedatives When Taking Opioids) | Sometimes | 9 Participants |
| Control - Permanent or Stable Housing | Subgroup Analyses- Change in Overdose Risk (Use of Sedatives When Taking Opioids) | Sometimes | 3 Participants |
| Control - Permanent or Stable Housing | Subgroup Analyses- Change in Overdose Risk (Use of Sedatives When Taking Opioids) | Always | 0 Participants |
| Control - Permanent or Stable Housing | Subgroup Analyses- Change in Overdose Risk (Use of Sedatives When Taking Opioids) | Never | 29 Participants |
| Control - Temporary or Unstable Housing or Unhoused. | Subgroup Analyses- Change in Overdose Risk (Use of Sedatives When Taking Opioids) | Always | 2 Participants |
| Control - Temporary or Unstable Housing or Unhoused. | Subgroup Analyses- Change in Overdose Risk (Use of Sedatives When Taking Opioids) | Never | 16 Participants |
| Control - Temporary or Unstable Housing or Unhoused. | Subgroup Analyses- Change in Overdose Risk (Use of Sedatives When Taking Opioids) | Sometimes | 8 Participants |
Secondary
Sub-group Analyses - Change in Overdose Risk (Using Alone When Taking Opioids)
Sub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes means at 3 month follow-up.)
Time frame: 3 months
Population: Mean days using opioids alone, among people who used one or more days in the past 30 by housing status. In the past 30 days, how many days have you used opioids when nobody else was around?
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention (OOPEN+BBCC) | Sub-group Analyses - Change in Overdose Risk (Using Alone When Taking Opioids) | 19.1 days in the past 30 | Standard Deviation 10.8 |
| Control | Sub-group Analyses - Change in Overdose Risk (Using Alone When Taking Opioids) | 14.2 days in the past 30 | Standard Deviation 11.1 |
| Control - Permanent or Stable Housing | Sub-group Analyses - Change in Overdose Risk (Using Alone When Taking Opioids) | 17.7 days in the past 30 | Standard Deviation 10.8 |
| Control - Temporary or Unstable Housing or Unhoused. | Sub-group Analyses - Change in Overdose Risk (Using Alone When Taking Opioids) | 15.4 days in the past 30 | Standard Deviation 11 |