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Repeated-dose Behavioral Intervention to Reduce Opioid Overdose (REBOOT)

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.
 
ClinicalTrials.gov Identifier: NCT03838510
Recruitment Status : Active, not recruiting
First Posted : February 12, 2019
Last Update Posted : August 16, 2022
Sponsor:
Information provided by (Responsible Party):
Phillip Coffin, MD, MIA, San Francisco Department of Public Health

Tracking Information
First Submitted Date  ICMJE February 7, 2019
First Posted Date  ICMJE February 12, 2019
Last Update Posted Date August 16, 2022
Actual Study Start Date  ICMJE April 22, 2019
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2019)
  • Occurrence of overdose events [ Time Frame: 16 Months ]
    Occurrence of overdose events will be measured by self-report via timeline follow-back (TLFB) assessment, ED/EMS records, and Vital records.
  • 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.
  • Days of substance use treatment [ Time Frame: 16 Months ]
    Days of substance use treatment will be measured by self-report via TLFB and with appropriate HIPAA/CFR-42 release.
  • Dates of substance use treatment [ Time Frame: 16 Months ]
    Dates of substance use treatment will be measured by self-report via TLFB and with appropriate HIPAA/CFR-42 release.
  • Modality of substance use treatment [ Time Frame: 16 Months ]
    Substance use treatment modality will be measured by self-report via TLFB and with appropriate HIPAA/CFR-42 release.
  • Number of days of opioid use [ Time Frame: 16 Months ]
    Days of substance use treatment will be measured by self-report via TLFB.
Original Primary Outcome Measures  ICMJE
 (submitted: February 8, 2019)
  • Overdose events [ Time Frame: 16 Months ]
    Overdose events will be measured by self-report via timeline follow-back (TLFB) assessment, ED/EMS records, and Vital records.
  • Days of substance use treatment [ Time Frame: 16 Months ]
    Days of substance use treatment will be measured by self-report via TLFB and with appropriate HIPAA/CFR-42 release.
  • Dates of substance use treatment [ Time Frame: 16 Months ]
    Dates of substance use treatment will be measured by self-report via TLFB and with appropriate HIPAA/CFR-42 release.
  • Modality of substance use treatment [ Time Frame: 16 Months ]
    Substance use treatment modality will be measured by self-report via TLFB and with appropriate HIPAA/CFR-42 release.
  • Number of days of opioid use [ Time Frame: 16 Months ]
    Days of substance use treatment will be measured by self-report via TLFB.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Repeated-dose Behavioral Intervention to Reduce Opioid Overdose
Official Title  ICMJE Repeated-dose Behavioral Intervention to Reduce Opioid Overdose: A Two-Site Randomized-Controlled Efficacy Trial (REBOOT)
Brief 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. This study will test the efficacy of REBOOT vs attention-control.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Opioid-Related Disorders
  • Drug Overdose
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Brief Counseling Intervention
    Intervention: Behavioral: REBOOT
  • No Intervention: Control Group
Publications * McMahan 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 15, 2022)
268
Original Estimated Enrollment  ICMJE
 (submitted: February 8, 2019)
300
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03838510
Other Study ID Numbers  ICMJE 5R01DA045690-02( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Phillip Coffin, MD, MIA, San Francisco Department of Public Health
Original Responsible Party Same as current
Current Study Sponsor  ICMJE San Francisco Department of Public Health
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Phillip O Coffin, MD, MIA San Francisco Department of Public Health
PRS Account San Francisco Department of Public Health
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP