Opioid-Related DisordersREBOOTNCT03838510
Repeated-dose Behavioral Intervention to Reduce Opioid Overdose
A study testing REBOOT in people with Opioid-Related Disorders and Drug Overdose, run by San Francisco Department of Public Health at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid-Related Disorders, Drug Overdose
- What is being tested?
- REBOOT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Apr 2019to 12 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boston Medical Center
Boston, Massachusetts, 02118
San Francisco Department of Public Health
San Francisco, California, 94102
About this study
Official title: Repeated-dose Behavioral Intervention to Reduce Opioid Overdose: A Two-Site Randomized-Controlled Efficacy Trial (REBOOT)
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.
- Conditions
- Opioid-Related Disorders, Drug Overdose
- Being tested
- REBOOT
- Medical subject headings
- Opioid-Related Disorders, Drug Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REBOOTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Brief Counseling Intervention | Experimental | Not described Receives: Behavioral: REBOOT |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start22 Apr 2019
- Primary completion12 Dec 2023
- Study completion12 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opioid-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Francisco Department of Public Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Phillip Coffin, MD, MIA, San Francisco Department of Public Health
- Investigators
- Phillip O Coffin, MD, MIA, Principal investigator, San Francisco Department of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03838510
- Sponsor's protocol ID
- 5R01DA045690-02
- Acronym
- REBOOT
- Status last verified
- May 2025
- First submitted
- 7 Feb 2019
- Last updated
- 15 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Harris MTH, Laks J, Hurstak E, Jain JP, Lambert AM, Maschke AD, Bagley SM, Farley J, Coffin PO, McMahan VM, Barrett C, Walley AY, Gunn CM. "If you're strung out and female, they will take advantage of you": A qualitative study exploring drug use and substance use service experiences among women in Boston and San Francisco. J Subst Use Addict Treat. 2024 Feb;157:209190. doi: 10.1016/j.josat.2023.209190. Epub 2023 Oct 20.
PubMed 37866442McMahan VM, Arenander J, Matheson T, Lambert AM, Brennan S, Green TC, Walley AY, Coffin PO. "There's No Heroin Around Anymore. It's All Fentanyl." Adaptation of an Opioid Overdose Prevention Counseling Approach to Address Fentanyl Overdose: Formative Study. JMIR Form Res. 2022 Sep 7;6(9):e37483. doi: 10.2196/37483.
PubMed 36069781
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeated-dose Behavioral Intervention to Reduce Opioid Overdose: A Two-Site Randomized-Controlled Efficacy Trial (REBOOT)
- ClinicalTrials.gov ID
- NCT03838510
- Acronym / sponsor ID
- REBOOT / 5R01DA045690-02
- Conditions
- Opioid-Related Disorders, Drug Overdose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- San Francisco Department of Public HealthOther government
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- 12 Dec 2023 (actual)
- First posted
- 12 Feb 2019 (actual)
- Results
- Posted 15 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Counseling Intervention | Experimental | Behavioral: REBOOT |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REBOOTThe 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. | Behavioural | Brief Counseling Intervention |
Primary outcome
Number of Overdose Events
Time frame: 16 Months
Number of overdose events will be measured by self-report via timeline follow-back (TLFB) assessment, ED/EMS records, and Vital records.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37866442Harris MTH, Laks J, Hurstak E, Jain JP, Lambert AM, Maschke AD, Bagley SM, Farley J, Coffin PO, McMahan VM, Barrett C, Walley AY, Gunn CM. "If you're strung out and female, they will take advantage of you": A qualitative study exploring drug use and substance use service experiences among women in Boston and San Francisco. J Subst Use Addict Treat. 2024 Feb;157:209190. doi: 10.1016/j.josat.2023.209190. Epub 2023 Oct 20.
- Derived from this study: PubMed 36069781McMahan VM, Arenander J, Matheson T, Lambert AM, Brennan S, Green TC, Walley AY, Coffin PO. "There's No Heroin Around Anymore. It's All Fentanyl." Adaptation of an Opioid Overdose Prevention Counseling Approach to Address Fentanyl Overdose: Formative Study. JMIR Form Res. 2022 Sep 7;6(9):e37483. doi: 10.2196/37483.
Related trials for Opioid-Related Disorders
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phillip O Coffin, MD, MIA principal investigator
San Francisco Department of Public Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REBOOT in people with Opioid-Related Disorders and Drug Overdose, run by San Francisco Department of Public Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Overdose Events (time frame: 16 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03838510, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.