Opioid-Related DisordersREBOOTNCT02093559
Repeated-dose Brief Intervention to Reduce Overdose and Risk Behaviors Among Naloxone Recipients
A study testing Brief counseling Intervention in people with Opioid-Related Disorders and Drug Overdose, run by San Francisco Department of Public Health at 1 site in United States.
Trial summary
REBOOT is a pilot randomized trial of a repeated-dose brief intervention to reduce overdose and risk behaviors among naloxone recipients (REBOOT). 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?
- Brief counseling Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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;
- current opioid dependence by SCID
- urine positive for opioids during screening, excluding prescribed agonist maintenance therapy
- history of prior opioid overdose
- previously received take-home naloxone
- no serious illnesses likely to progress clinically during trial
- able and willing to provide informed consent, provide locator information, communicate in English, adhere to visit schedule
Who cannot join
- suicidal ideation by concise health risk tracking (CHRT)
- currently participating in another interventional research study that could possible impact the study's outcomes of interest
- any condition that, in the Principal Investigator's judgment, interferes with safe study participation or adherence to study procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Substance Use Research Unit
San Francisco, California, 94102
About this study
REBOOT is a pilot randomized trial of a repeated-dose brief intervention to reduce overdose and risk behaviors among naloxone recipients (REBOOT). It includes an established overdose education curriculum within an Informational-Motivation-Behavior (IMB) model. This study will test the feasibility of an efficacy trial of REBOOT vs treatment as usual (information and referrals) that will evaluate overdose events (non-fatal or death), drug use cessation, and overdose and HIV risk behaviors, among opioid-dependent persons who have previously overdosed and already received take-home naloxone (the opioid antagonist used to reverse overdose).
- Conditions
- Opioid-Related Disorders, Drug Overdose
- Being tested
- Brief counseling Intervention
- Keywords
- Clinical Trial, Naloxone, Motivational Interviewing
- 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.
Brief counseling InterventionBehavioural
The brief counseling intervention will utilize MI 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 HIV risk behaviors and determine readiness for change in substance use.
| Study group | Role | What they receive |
|---|---|---|
| Brief Counseling Intervention | Experimental | The brief counseling intervention will utilize MI 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 HIV risk behaviors and determine readiness for change in substance use. Receives: Behavioral: Brief counseling Intervention |
| Control Group | No intervention | The control group will have access to brochures and be offered referral to services requested. SFDPH Community Behavioral Health Services (CBHS) provides immediate access to substance abuse treatment in San Francisco, including office- and clinic-based methadone and buprenorphine treatment. Given the pilot nature of this study, the control group will not be a full attention control; we will account for an attention effect due to assessment alone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of a randomized trial with REBOOT
To determine feasibility of a randomized trial with REBOOT, we will calculate screening and visit completion rates from the study database, with exact 95% confidence intervals (CIs), overall and by arm. Between-group differences will be assessed using Fisher's exact and Wilcoxon ranksum tests. We will calculate Kaplan-Meier curves for time to dropout, by group, and test for differences using the log-rank test.
Measured: 16 months
Acceptability of REBOOT
To determine acceptability of REBOOT, we will calculate counseling completion rates from the study database by visit, and tabulate the proportions of active arm participants attending 0-4 counseling sessions. Via ACASI, we will inquire about participant satisfaction with the intervention and belief that it affected their drug use behaviors; responses will be presented as means, medians, or proportions, as appropriate, with 95% CIs.
Measured: 16 months
Influence of egocentric social network characteristics on overdose events and naloxone use
To evaluate the influence of egocentric social network characteristics on overdose events and naloxone use, we will use GEE Poisson models with robust standard errors to evaluate the association between network size, evaluated at baseline and each return visit, and numbers of experienced and witnessed overdose events in the same period; zero-inflated models will be used if needed. In addition, we will explore the influence of homophily and assortativity on experienced and witnessed overdose events using similar methods. Newman's method will be used to calculate assortativity coefficients, a measure of the degree of demographic and risk behavior similarity within participants' egocentric networks.
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 posted21 Mar 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- None (open label)
- Enrolment
- 63 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 Coffin, MD, MIA, Principal investigator, San Francisco Department of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02093559
- Sponsor's protocol ID
- 1R34DA037194-01A1
- Acronym
- REBOOT
- Status last verified
- Nov 2023
- First submitted
- 19 Mar 2014
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Reed GE, McMahan VM, Chang YG, Johnson NL, Walley AY, Coffin PO, Harris MTH. A comparison of opioid overdose risk behaviors by race and ethnicity among overdose survivors in Boston, MA, and San Francisco, CA. Harm Reduct J. 2026 Apr 20;23(1):97. doi: 10.1186/s12954-026-01451-9.
PubMed 42010666Reed GE, McMahan VM, Chang YG, Johnson NL, Walley AY, Coffin PO, Harris MT. A Comparison of Opioid Overdose Risk Behaviors by Race and Ethnicity Among Overdose Survivors in Boston, MA, and San Francisco, CA. Res Sq [Preprint]. 2026 Feb 13:rs.3.rs-8216462. doi: 10.21203/rs.3.rs-8216462/v1.
PubMed 41727581Coffin PO, Santos GM, Matheson T, Behar E, Rowe C, Rubin T, Silvis J, Vittinghoff E. Behavioral intervention to reduce opioid overdose among high-risk persons with opioid use disorder: A pilot randomized controlled trial. PLoS One. 2017 Oct 19;12(10):e0183354. doi: 10.1371/journal.pone.0183354. eCollection 2017.
PubMed 29049282
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeated-dose Brief Intervention to Reduce Overdose and Risk Behaviors Among Naloxone Recipients
- ClinicalTrials.gov ID
- NCT02093559
- Acronym / sponsor ID
- REBOOT / 1R34DA037194-01A1
- Conditions
- Opioid-Related Disorders, Drug Overdose
- Keywords
- Clinical Trial, Naloxone, Motivational Interviewing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- San Francisco Department of Public HealthOther government
- Study start
- Jul 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 21 Mar 2014 (estimated)
- Results
- Not posted in the source record
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 pilot randomized trial of a repeated-dose brief intervention to reduce overdose and risk behaviors among naloxone recipients (REBOOT). It includes an established overdose education curriculum within an Informational-Motivation-Behavior (IMB) model. This study will test the feasibility of an efficacy trial of REBOOT vs treatment as usual (information and referrals) that will evaluate overdose events (non-fatal or death), drug use cessation, and overdose and HIV risk behaviors, among opioid-dependent persons who have previously overdosed and already received take-home naloxone (the opioid antagonist used to reverse overdose).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Counseling Intervention | Experimental | Behavioral: Brief counseling InterventionThe brief counseling intervention will utilize MI 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 HIV risk behaviors and determine readiness for change in substance use. |
| Control Group | No intervention | –The control group will have access to brochures and be offered referral to services requested. SFDPH Community Behavioral Health Services (CBHS) provides immediate access to substance abuse treatment in San Francisco, including office- and clinic-based methadone and buprenorphine treatment. Given the pilot nature of this study, the control group will not be a full attention control; we will account for an attention effect due to assessment alone. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age 18-65 years;
- current opioid dependence by SCID
- urine positive for opioids during screening, excluding prescribed agonist maintenance therapy
- history of prior opioid overdose
- previously received take-home naloxone
Key exclusion criteria (3 listed)
- suicidal ideation by concise health risk tracking (CHRT)
- currently participating in another interventional research study that could possible impact the study's outcomes of interest
- 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 |
|---|---|---|
| Brief counseling InterventionThe brief counseling intervention will utilize MI 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 HIV risk behaviors and determine readiness for change in substance use. | Behavioural | Brief Counseling Intervention |
Primary outcome
Feasibility of a randomized trial with REBOOT
Time frame: 16 months
To determine feasibility of a randomized trial with REBOOT, we will calculate screening and visit completion rates from the study database, with exact 95% confidence intervals (CIs), overall and by arm. Between-group differences will be assessed using Fisher's exact and Wilcoxon ranksum tests. We will calculate Kaplan-Meier curves for time to dropout, by group, and test for differences using the log-rank test.
Acceptability of REBOOT
Time frame: 16 months
To determine acceptability of REBOOT, we will calculate counseling completion rates from the study database by visit, and tabulate the proportions of active arm participants attending 0-4 counseling sessions. Via ACASI, we will inquire about participant satisfaction with the intervention and belief that it affected their drug use behaviors; responses will be presented as means, medians, or proportions, as appropriate, with 95% CIs.
Influence of egocentric social network characteristics on overdose events and naloxone use
Time frame: 16 months
To evaluate the influence of egocentric social network characteristics on overdose events and naloxone use, we will use GEE Poisson models with robust standard errors to evaluate the association between network size, evaluated at baseline and each return visit, and numbers of experienced and witnessed overdose events in the same period; zero-inflated models will be used if needed. In addition, we will explore the influence of homophily and assortativity on experienced and witnessed overdose events using similar methods. Newman's method will be used to calculate assortativity coefficients, a measure of the degree of demographic and risk behavior similarity within participants' egocentric networks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Derived from this study: PubMed 42010666Reed GE, McMahan VM, Chang YG, Johnson NL, Walley AY, Coffin PO, Harris MTH. A comparison of opioid overdose risk behaviors by race and ethnicity among overdose survivors in Boston, MA, and San Francisco, CA. Harm Reduct J. 2026 Apr 20;23(1):97. doi: 10.1186/s12954-026-01451-9.
- Derived from this study: PubMed 41727581Reed GE, McMahan VM, Chang YG, Johnson NL, Walley AY, Coffin PO, Harris MT. A Comparison of Opioid Overdose Risk Behaviors by Race and Ethnicity Among Overdose Survivors in Boston, MA, and San Francisco, CA. Res Sq [Preprint]. 2026 Feb 13:rs.3.rs-8216462. doi: 10.21203/rs.3.rs-8216462/v1.
- Derived from this study: PubMed 29049282Coffin PO, Santos GM, Matheson T, Behar E, Rowe C, Rubin T, Silvis J, Vittinghoff E. Behavioral intervention to reduce opioid overdose among high-risk persons with opioid use disorder: A pilot randomized controlled trial. PLoS One. 2017 Oct 19;12(10):e0183354. doi: 10.1371/journal.pone.0183354. eCollection 2017.
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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 Coffin, MD, MIA principal investigator
San Francisco Department of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief counseling Intervention in people with Opioid-Related Disorders and Drug Overdose, run by San Francisco Department of Public Health at 1 site 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 7 inclusion and 3 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 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility of a randomized trial with REBOOT (time frame: 16 months). The study lists 3 primary outcomes in all. 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 NCT02093559, which also lists 3 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 22 Nov 2023.