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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Opioid-Related Disorders Drug Overdose Behavioral: REBOOT Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 268 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Repeated-dose Behavioral Intervention to Reduce Opioid Overdose: A Two-Site Randomized-Controlled Efficacy Trial (REBOOT)
Actual Study Start Date : April 22, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Opioid Overdose

Arms and Interventions
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Arm Intervention/treatment
Experimental: Brief Counseling Intervention 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.
No Intervention: Control Group


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Number of days of opioid use [ Time Frame: 16 Months ]
    Days of substance use treatment will be measured by self-report via TLFB.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT03838510


Locations
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United States, California
San Francisco Department of Public Health
San Francisco, California, United States, 94102
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
San Francisco Department of Public Health
Investigators
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Principal Investigator: Phillip O Coffin, MD, MIA San Francisco Department of Public Health
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Phillip Coffin, MD, MIA, Director, Substance Use Research Unit, San Francisco Department of Public Health
ClinicalTrials.gov Identifier: NCT03838510    
Other Study ID Numbers: 5R01DA045690-02 ( U.S. NIH Grant/Contract )
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: August 16, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Drug Overdose
Opioid-Related Disorders
Opiate Overdose
Substance-Related Disorders
 Chemically-Induced Disorders
Narcotic-Related Disorders
Mental Disorders