Drug Overdose, Opioid-Related Disorders
Conditions
Brief summary
REBOOT is a randomized trial of a repeated-dose brief intervention to reduce overdose and risk behaviors among naloxone recipients with opioid use disorder. It includes an established overdose education curriculum within an Informational-Motivation-Behavior (IMB) model. This study will test the efficacy of REBOOT vs attention-control.
Interventions
BEHAVIORALREBOOT
The brief counseling intervention will utilize Motivational Interviewing and skills-building techniques to modify personal overdose risk behaviors and develop skills as a peer responder for witnessed overdose. The counselor will draw upon themes of safer substance use to address overdose risk behaviors and determine readiness for change in substance use.
Sponsors
San Francisco Department of Public Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-65 years * Characteristics of opioid use history * Previously received take-home naloxone * No life-threatening illness likely to progress clinically during trial * Able/willing to provide informed consent and locator information, communicate in English, and adhere to visit schedule
Exclusion criteria
* Suicidal ideation * Participating in another interventional study that could possibly impact the study's outcomes of interest * Planning to leave San Francisco/Boston metro area during study * Previously exposed to REBOOT counseling intervention * Any condition that, in the Principal Investigator's judgment, interferes with safe study participation or adherence to study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Overdose Events | 16 Months | Number of overdose events will be measured by self-report via timeline follow-back (TLFB) assessment, ED/EMS records, and Vital records. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Brief Counseling Intervention REBOOT: The brief counseling intervention will utilize Motivational Interviewing and skills-building techniques to modify personal overdose risk behaviors and develop skills as a peer responder for witnessed overdose. The counselor will draw upon themes of safer substance use to address overdose risk behaviors and determine readiness for change in substance use. | 133 |
| Control Group Participants in the control group will watch a show or listen to a podcast for the same amount of time as an intervention session as an attention control. | 135 |
| Total | 268 |
Baseline characteristics
| Characteristic | Control Group | Total | Brief Counseling Intervention |
|---|---|---|---|
| Age, Continuous | 41.7 years STANDARD_DEVIATION 9.9 | 43 years STANDARD_DEVIATION 10 | 43.4 years STANDARD_DEVIATION 10.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 22 Participants | 39 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 110 Participants | 226 Participants | 116 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 37 Participants | 18 Participants |
| Race (NIH/OMB) More than one race | 15 Participants | 25 Participants | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 14 Participants | 23 Participants | 9 Participants |
| Race (NIH/OMB) White | 84 Participants | 174 Participants | 90 Participants |
| Region of Enrollment United States | 135 Participants | 268 Participants | 133 Participants |
| Sex/Gender, Customized Female | 54 Participants | 100 Participants | 46 Participants |
| Sex/Gender, Customized Male | 79 Participants | 165 Participants | 86 Participants |
| Sex/Gender, Customized Other | 1 Participants | 1 Participants | 0 Participants |
| Sex/Gender, Customized Trans female | 1 Participants | 2 Participants | 1 Participants |
| Sex/Gender, Customized Trans male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 133 | 4 / 135 |
| other Total, other adverse events | 69 / 133 | 60 / 135 |
| serious Total, serious adverse events | 88 / 133 | 78 / 135 |
Outcome results
Primary
Number of Overdose Events
Number of overdose events will be measured by self-report via timeline follow-back (TLFB) assessment, ED/EMS records, and Vital records.
Time frame: 16 Months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Brief Counseling Intervention | Number of Overdose Events | 0 overdoses |
| Control Group | Number of Overdose Events | 0 overdoses |