An interventional study of REBOOT in Opioid-Related Disorders and Drug Overdose, sponsored by San Francisco Department of Public Health. Completed at 2 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-06-15.
Sponsored by San Francisco Department of Public Health · Not applicable, Interventional, and Prevention
Among 1,222 studies in Opioid-Related Disorders with a site in United States — 246 open to participants now, 316 under way, 20 of them phase 3. Opioid-Related Disorders · United States.
Among the 1,222 studies in Opioid-Related Disorders with a site in United States, this one is the 187th largest by enrollment of the 1,097 interventional ones, is one of 86 that started in 2019, is one of 569 with no phase, and was the 529th registered.
1,472 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's enrollment of 268 is above the median of 63 across 1,166 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →246 of the 1,222 studies in Opioid-Related Disorders with a site in United States are open now, in 7 countries. Each count lists the studies.
Of the 210 Opioid-Related Disorders studies recruiting now, 122 (58%) set no upper age limit and 74 (35%) stop at 75 or younger; 14 take children under 18; 52 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →1,222 studies; the count open now beside each. This study's row is marked.
First in 1988; this study’s year is marked. 86 started in 2019.
Median enrollment 56 across the 1,097 interventional studies, 85 across the 122 observational. Of the 833 that completed or were terminated, 331 (40%) have results posted.
132 of 1,222 have an industry lead sponsor. The 10 most frequent:
San Francisco Department of Public Health is the lead sponsor of 14 studies on the registry; 2 are open to participants now.
San Francisco Department of Public Health has 2 studies filed under Opioid-Related Disorders — fewer than ten, so there is no comparison to draw.
128 of the studies in Opioid-Related Disorders with a site in United States that are under way reach primary completion within a year, 9 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05011266Phase 3New York State Psychiatric InstituteEfficacy of Buprenorphine and XR-Naltrexone Combination for Relapse Prevention in Opioid Use Disorder | 2027-01-01 |
| NCT05834478Phase 3Emory UniversityNon-invasive Vagal Nerve Stimulation in Opioid Use Disorders UH3 | 2027-02 |
| NCT05033028Phase 3NYU Langone HealthSmartphones for Opiate Addiction Recovery | 2027-06-01 |
| NCT05459402Phase 3University of Maryland, BaltimoreDivided or Single Exposure (DOSE) Study | 2027-06-01 |
| NCT05766631Phase 3Friends Research Institute, Inc.Treating Polysubstance Use Using a Novel Digital Technology | 2027-06-30 |
Among the 1,222 studies in Opioid-Related Disorders with a site in United States, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: 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.
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
| Milestone | Brief Counseling Intervention | Control Group |
|---|---|---|
| Started | 133 | 135 |
| Completed | 112 | 121 |
| Not completed | 21 | 14 |
Number of overdose events will be measured by self-report via timeline follow-back (TLFB) assessment, ED/EMS records, and Vital records.
| overdoses | Brief Counseling Intervention | Control Group |
|---|---|---|
| Number of Overdose Events | 0 (0 to 1) | 0 (0 to 1) |
Collected over 16 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Brief Counseling Intervention | 4/133 (3%) | 88/133 (66.2%) | 69/133 (51.9%) |
| Control Group | 4/135 (3%) | 78/135 (57.8%) | 60/135 (44.4%) |
| Event | Brief Counseling Intervention | Control Group |
|---|---|---|
| heart murmurCardiac disorders | 1/133 | 0/135 |
| endocarditisCardiac disorders | 1/133 | 0/135 |
| overdoseCardiac disorders | 1/133 | 0/135 |
| high blood sugarEndocrine disorders | 1/133 | 0/135 |
| constipationGastrointestinal disorders | 1/133 | 0/135 |
| GERDGastrointestinal disorders | 1/133 | 0/135 |
| adverse reaction to medicationGeneral disorders | 1/133 | 0/135 |
| sepsisImmune system disorders | 1/133 | 0/135 |
| adverse reaction to medicationImmune system disorders | 1/133 | 0/135 |
| strep throatInfections and infestations | 1/133 | 0/135 |
| Event | Brief Counseling Intervention | Control Group |
|---|---|---|
| leg swellingBlood and lymphatic system disorders | 1/133 | 0/135 |
| stomach/bowel issueGastrointestinal disorders | 1/133 | 0/135 |
| ulcerative colitisGastrointestinal disorders | 1/133 | 0/135 |
| colon painGastrointestinal disorders | 1/133 | 0/135 |
| diarrheaGastrointestinal disorders | 1/133 | 0/135 |
| withdrawal symptomsGastrointestinal disorders | 1/133 | 0/135 |
| soreness due to dental workGeneral disorders | 1/133 | 0/135 |
| withdrawal symptomsGeneral disorders | 1/133 | 0/135 |
| allergic reactionImmune system disorders | 1/133 | 0/135 |
| COVID-19Infections and infestations | 1/133 | 0/135 |
| Age, Continuous(years) | Brief Counseling Intervention | Control Group | Total |
|---|---|---|---|
| Mean | 43.4 ± 10.2 | 41.7 ± 9.9 | 43 ± 10 |
| Sex/Gender, Customized(Participants) | Brief Counseling Intervention | Control Group | Total |
|---|---|---|---|
| Male | 86 | 79 | 165 |
| Female | 46 | 54 | 100 |
| Trans female | 1 | 1 | 2 |
| Trans male | 0 | 0 | 0 |
| Other | 0 | 1 | 1 |
| Ethnicity (NIH/OMB)(Participants) | Brief Counseling Intervention | Control Group | Total |
|---|---|---|---|
| Hispanic or Latino | 17 | 22 | 39 |
| Not Hispanic or Latino | 116 | 110 | 226 |
| Unknown or Not Reported | 0 | 3 | 3 |
| Race (NIH/OMB)(Participants) | Brief Counseling Intervention | Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 4 | 2 | 6 |
| Asian | 2 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 18 | 19 | 37 |
| White | 90 | 84 | 174 |
| More than one race | 10 | 15 | 25 |
| Unknown or Not Reported | 9 | 14 | 23 |
| Region of Enrollment(Participants) | Brief Counseling Intervention | Control Group | Total |
|---|---|---|---|
| United States | 133 | 135 | 268 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Apr 2019 to primary completion in Dec 2023, 55 months.
Results were first posted in Jun 2025, 1 year 6 months after primary completion.
Of 464 non-industry interventional studies with no phase under Opioid-Related Disorders, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 47. This study's 55 months is above that.
Counting every sponsor, half of 495 studies reached it within 29 months; a quarter within 13 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
San Francisco Department of Public Health