Drug Abuse, Drug Addiction, Drug Overdose, Opioid-Related Disorders, Substance Abuse
Conditions
Keywords
Opioid Substitution Treatment, Telephone intervention, secondary prevention, naloxone
Brief summary
This project will further develop and test the Tailored Telephone Intervention delivered by Peers to Prevent Recurring Opioid Overdoses (TTIP-PRO), a promising, low-cost, intervention to facilitate entry into medication assisted treatment (MAT) for individuals experiencing a non-fatal opioid overdoses (OOD). A prior small-scale pilot/feasibility study of TTIP-PRO (NCT02282306) found that the participating patients and the Peer Interventionists were satisfied with their participation, the intervention was acceptable, and the system for generating patient-tailored intervention information performed well. The overall goal of the present study is to conduct a pilot randomized controlled trial of TTIP-PRO versus a control group. It is hypothesized that patients in the TTIP-PRO group will have more favorable drug-abuse-related outcomes than patients in the control group.
Detailed description
This pilot study is a randomized controlled intent-to-treat (ITT) clinical trial. Approximately eighty eligible participants will be randomized in a 1:1 ratio to the control condition (Information and NARCAN® (naloxone) Nasal Spray kit) or to the experimental condition (TTIP-PRO in addition to the elements provided in the control condition). All participants will complete a follow-up phone call approximately 3-weeks post-randomization, during which process measures will be completed, and in-person visits at approximately 3, 6-, and 12-months following enrollment. This is a single site study; all data will be collected at the University of Cincinnati. Approximately 80 participants will be randomized into this pilot efficacy trial. The hypotheses to be tested include that participants assigned to the TTIP-PRO intervention will: have a higher rate of enrollment in MAT, have a lower rate of recurring opioid overdose, and have greater reduction in illicit opioid use.
Interventions
BEHAVIORALPeer Intervention
The Peer Intervention is a 20-minute telephone call delivered by a Peer Interventionist, who is trained to answer questions about the content of the personally-tailored information packets. The primary goal of the call is for the participant and the Peer Interventionist to have an open exchange of information about medication-assisted treatment (MAT) for opioid use disorder.
DRUGnaloxone nasal spray kit
Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose. This nasal spray is approved by the FDA for reversing OODs and has a favorable side-effects profile. A take-home kit will be provided to the patient participants, which may be useful in the event of a future opioid overdose.
BEHAVIORALPersonally-tailored opioid overdose prevention education (information packet)
Personally-tailored information packet with three participant-specific reports (Personal Overdose Risk Factors Report; Medication Assisted Treatment (MAT) Report; and the Opioid Overdose Information Report), and general written information about opioid overdose and treatment for opioid use disorder.
Sponsors
National Institute on Drug Abuse (NIDA)
University of Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Report having been treated for an OOD within the past 6 months * Age 18 years or older; * Scores high risk for heroin and/or non-medical use of prescription opioids on the National Institute on Drug Abuse modified Alcohol, Smoking and Substance Involvement Screening Test (NIDA-modified ASSIST) (i.e., ≥ 27) * Be able to understand the study, and having understood, provide written informed consent in English * Access to a phone (for TTIP-PRO intervention and phone follow-up) * Be willing to have their intervention audio recorded and rated if randomized to TTIP-PRO * Have an opioid-positive baseline/screening urine drug screen.
Exclusion criteria
* In the judgment of the investigator, would not be expected to complete the study protocol (e.g., due to relocation from the clinic area, probable incarceration, etc.) * Current engagement in addiction treatment * Residence more than 40 miles from the location of follow-up visits * Inability to provide sufficient contact information (must provide at least 2 reliable locators) * Prior participation in the current study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication-Assisted Treatment Enrollment | 12 months | whether or not participant enrolled in medication-assisted treatment within the follow-up period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Overdose Experience | 12 months | whether or not participant experienced an opioid overdose within the follow-up period period. |
| Change in Opioid Use (Timeline Follow-back) | at 12-month visit | Difference in self-reported opioid use in the prior 28 days, from Baseline to 12-month visit, computed as: (12-month opioid use days - Baseline opioid use days); negative values indicate a reduction in self-reported opioid use days from Baseline to 12-month visit. |
| Change in Opioid Use (Urine Drug Screen) | at 12-month visit | Number of participants who provided an opioid-negative urine sample, assessed by a rapid urine drug screen system, at the 12-month visit. Results that were positive, but specific to only buprenorphine or methadone, were counted as negative for participants with verified enrollment in medication-assisted treatment. Note that all participants were required to have an opioid-positive urine sample at Baseline, in order to be eligible for the study. |
Countries
United States
Participant flow
Recruitment details
Potential participants were recruited through various methods including advertisements, flyers, and word-of-mouth. Greater than 90% of participants were recruited from a syringe exchange program. All participants were given a thorough explanation of the study and signed an informed consent form.
Pre-assignment details
116 potential participants were consented and screened, and 80 were randomized to Personally-tailored opioid overdose education and naloxone distribution plus Peer Intervention (PTOEND+PI) (n=40) or PTOEND (n=40).
Participants by arm
| Arm | Count |
|---|---|
| PTOEND PTOEND: Personally-tailored opioid overdose prevention education and naloxone distribution.
Participants in this arm will be given a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment.
naloxone nasal spray kit: Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose.
Personally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder. | 40 |
| PTOEND+PI PTOEND+PI: Personally-tailored opioid overdose prevention education and naloxone distribution, plus Peer Intervention.
In addition to a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment, participants randomized to this arm will also receive the experimental Peer Intervention.
Peer Intervention: The Peer Intervention is a 20-minute telephone call delivered by a Peer Interventionist, who is trained to answer questions about the content of the personally-tailored information packets.
naloxone nasal spray kit: Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose.
Personally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder. | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | PTOEND+PI | Total | PTOEND |
|---|---|---|---|
| Age, Continuous | 40.3 years STANDARD_DEVIATION 12.5 | 39.1 years STANDARD_DEVIATION 11.4 | 38.0 years STANDARD_DEVIATION 10.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants | 78 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 10 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 32 Participants | 64 Participants | 32 Participants |
| Sex: Female, Male Female | 14 Participants | 36 Participants | 22 Participants |
| Sex: Female, Male Male | 26 Participants | 44 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 9 / 40 | 7 / 40 |
Outcome results
Primary
Medication-Assisted Treatment Enrollment
whether or not participant enrolled in medication-assisted treatment within the follow-up period
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PTOEND | Medication-Assisted Treatment Enrollment | 7 Participants |
| PTOEND+PI | Medication-Assisted Treatment Enrollment | 13 Participants |
Secondary
Change in Opioid Use (Timeline Follow-back)
Difference in self-reported opioid use in the prior 28 days, from Baseline to 12-month visit, computed as: (12-month opioid use days - Baseline opioid use days); negative values indicate a reduction in self-reported opioid use days from Baseline to 12-month visit.
Time frame: at 12-month visit
Population: Analysis could only be done on data provided by participants who attended the 12-month visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PTOEND | Change in Opioid Use (Timeline Follow-back) | -10.2 days | Standard Deviation 12.7 |
| PTOEND+PI | Change in Opioid Use (Timeline Follow-back) | -8.7 days | Standard Deviation 13.6 |
Secondary
Change in Opioid Use (Urine Drug Screen)
Number of participants who provided an opioid-negative urine sample, assessed by a rapid urine drug screen system, at the 12-month visit. Results that were positive, but specific to only buprenorphine or methadone, were counted as negative for participants with verified enrollment in medication-assisted treatment. Note that all participants were required to have an opioid-positive urine sample at Baseline, in order to be eligible for the study.
Time frame: at 12-month visit
Population: Analysis could only be done on samples provided by participants who attended the 12-month visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PTOEND | Change in Opioid Use (Urine Drug Screen) | 18 Participants |
| PTOEND+PI | Change in Opioid Use (Urine Drug Screen) | 20 Participants |
Secondary
Opioid Overdose Experience
whether or not participant experienced an opioid overdose within the follow-up period period.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PTOEND | Opioid Overdose Experience | 13 Participants |
| PTOEND+PI | Opioid Overdose Experience | 5 Participants |