Back to resultsRepeated-dose Brief Intervention to Reduce Overdose and Risk Behaviors Among Naloxone Recipients (REBOOT)
Primary Purpose
Opioid-Related Disorders, Drug Overdose
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief counseling Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Opioid-Related Disorders focused on measuring Clinical Trial, Naloxone, Motivational Interviewing
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Substance Use Research Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Brief Counseling Intervention
Control Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02093559
First Posted
March 19, 2014
Last Updated
February 13, 2017
Sponsor
San Francisco Department of Public Health
1. Study Identification
Unique Protocol Identification Number
NCT02093559
Brief Title
Repeated-dose Brief Intervention to Reduce Overdose and Risk Behaviors Among Naloxone Recipients
Acronym
REBOOT
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Francisco Department of Public Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders, Drug Overdose
Keywords
Clinical Trial, Naloxone, Motivational Interviewing
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brief Counseling Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Brief counseling Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of a randomized trial with REBOOT
Description
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.
Time Frame
16 months
Title
Acceptability of REBOOT
Description
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.
Time Frame
16 months
Title
Influence of egocentric social network characteristics on overdose events and naloxone use
Description
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.
Time Frame
16 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phillip Coffin, MD, MIA
Organizational Affiliation
San Francisco Department of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Substance Use Research Unit
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29049282
Citation
Coffin 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.
Results Reference
derived
Learn more about this trial
Repeated-dose Brief Intervention to Reduce Overdose and Risk Behaviors Among Naloxone Recipients
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