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Trial record 1 of 5 for:    REBOOT
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Repeated-dose Brief Intervention to Reduce Overdose and Risk Behaviors Among Naloxone Recipients (REBOOT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02093559
First Posted: March 21, 2014
Last Update Posted: February 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Phillip Coffin, MD, MIA, San Francisco Department of Public Health
  Purpose
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).

Condition Intervention
Opioid-Related Disorders Drug Overdose Behavioral: Brief counseling Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Phillip Coffin, MD, MIA, San Francisco Department of Public Health:

Primary Outcome Measures:
  • 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.


Enrollment: 63
Study Start Date: July 2014
Study Completion Date: December 2016
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brief Counseling Intervention
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.
Behavioral: Brief counseling Intervention
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.
No Intervention: Control Group
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.

  Eligibility

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02093559


Locations
United States, California
Substance Use Research Unit
San Francisco, California, United States, 94102
Sponsors and Collaborators
San Francisco Department of Public Health
Investigators
Principal Investigator: Phillip Coffin, MD, MIA San Francisco Department of Public Health
  More Information

Responsible Party: Phillip Coffin, MD, MIA, Director, Substance Use Research Unit, San Francisco Department of Public Health
ClinicalTrials.gov Identifier: NCT02093559     History of Changes
Other Study ID Numbers: 1R34DA037194-01A1 ( U.S. NIH Grant/Contract )
First Submitted: March 19, 2014
First Posted: March 21, 2014
Last Update Posted: February 15, 2017
Last Verified: February 2017

Keywords provided by Phillip Coffin, MD, MIA, San Francisco Department of Public Health:
Clinical Trial
Naloxone
Motivational Interviewing

Additional relevant MeSH terms:
Opioid-Related Disorders
Drug Overdose
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naloxone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents