Buprenorphine Treatment Engagement and Overdose Prevention
2 other identifiers
interventional
41
1 country
1
Brief Summary
Office-based buprenorphine could be expanded to treat many of the opioid users who are not in treatment and who are at great risk for opioid overdose, but effective approaches are needed to help individuals with opioid use disorder initiate and remain in office-based buprenorphine treatment. Investigators propose to develop and pilot test a novel intervention that will combine video-based directly observed therapy and incentives to promote buprenorphine treatment engagement and adherence in out-of-treatment opioid users.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2018
CompletedFirst Posted
Study publicly available on registry
September 19, 2018
CompletedStudy Start
First participant enrolled
May 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2020
CompletedResults Posted
Study results publicly available
February 20, 2024
CompletedFebruary 20, 2024
July 1, 2023
1.2 years
September 18, 2018
August 29, 2022
July 24, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Buprenorphine Treatment Adherence
This will be assessed by the percentage of buprenorphine-positive urine samples during the 24-week intervention.
24 weeks
Secondary Outcomes (1)
Linkage to Treatment
24 weeks
Study Arms (2)
Usual Care
NO INTERVENTIONParticipants in this group will be referred to receive office-based buprenorphine treatment
Video DOT+
EXPERIMENTALParticipants in this group will be referred to receive office-based buprenorphine treatment and will receive financial incentives for taking their daily buprenorphine dose.
Interventions
Participants will receive financial incentives for recording and submitting videos of themselves taking their daily buprenorphine dose.
Eligibility Criteria
You may qualify if:
- opioid use disorder
You may not qualify if:
- current suicidal/homicidal ideation
- severe psychiatric disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Learning and Health
Baltimore, Maryland, 21224, United States
Related Publications (1)
Toegel F, Novak MD, Rodewald AM, Leoutsakos JM, Silverman K, Holtyn AF. Technology-assisted opioid education for out-of-treatment adults with opioid use disorder. Psychol Addict Behav. 2022 Aug;36(5):555-564. doi: 10.1037/adb0000769. Epub 2021 Jul 29.
PMID: 34323526DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kenneth Silverman, Professor
- Organization
- Johns Hopkins University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth Silverman, Ph.D.
Johns Hopkins School of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2018
First Posted
September 19, 2018
Study Start
May 1, 2019
Primary Completion
July 28, 2020
Study Completion
October 20, 2020
Last Updated
February 20, 2024
Results First Posted
February 20, 2024
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share