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Buprenorphine Treatment Engagement and Overdose Prevention

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ClinicalTrials.gov Identifier: NCT03677986
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : February 9, 2021
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE September 18, 2018
First Posted Date  ICMJE September 19, 2018
Last Update Posted Date February 9, 2021
Actual Study Start Date  ICMJE April 22, 2019
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2018)
Buprenorphine treatment adherence [ Time Frame: 24 weeks ]
This will be assessed by the percentage of buprenorphine-positive urine samples during the 24-week intervention
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2018)
Linkage to treatment [ Time Frame: 24 weeks ]
This will be assessed by the percentage of participants who get linked to buprenorphine treatment during the 24-week intervention
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Buprenorphine Treatment Engagement and Overdose Prevention
Official Title  ICMJE Mobile Technology for Buprenorphine Treatment Engagement and Overdose Prevention in Opioid Users
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.
Detailed Description The United States is experiencing an epidemic of opioid-related overdose deaths. Office-based buprenorphine treatment could expand access to treatment to the many opioid users who are not in treatment and who are at great risk for opioid overdose. However, office-based buprenorphine has two limitations that Investigators will address in this application: 1) Patients prescribed buprenorphine by office-based providers can divert the buprenorphine for illicit use. 2) Many people in need of buprenorphine treatment do not initiate and remain in office-based buprenorphine treatment. Investigators will use Video Directly Observed Therapy (DOT) and incentives to enhance office-based buprenorphine treatment. Video DOT is an innovative, mobile health platform that patients can use to record and submit videos of patients taking medication that are then viewable on a secure, web portal for providers to confirm medication adherence. Video DOT could facilitate adherence to buprenorphine treatment and safeguard against diversion. The addition of incentives could engage out-of-treatment opioid users into treatment and increase treatment retention. Incentive interventions, which provide incentives to patients meeting therapeutic goals, have been highly effective in promoting a wide range of health behaviors and have firm theoretical and empirical foundations. Incentive interventions can promote treatment engagement in individuals with substance use disorders, including out-of-treatment opioid users. Investigators propose to develop and pilot test a novel combination of Video DOT and incentives to promote buprenorphine treatment engagement and adherence in out-of-treatment opioid users. The Video DOT+ intervention will provide an incentive for linking to buprenorphine treatment and facilitate retention in treatment by providing incentives for maintaining daily buprenorphine use as verified by the Video DOT system. The incentives will be integrated into the Video DOT platform and delivered remotely to reloadable credit cards to allow for the entire intervention to be delivered via mobile technology and to facilitate easy dissemination of the Video DOT+ system. A randomized pilot study is planned over 3 years. Out-of-treatment opioid users (N=64) will be referred to buprenorphine treatment and randomly assigned to a Usual Care (Control) group or Video DOT+ group. Video DOT+ participants will receive the Video DOT+ intervention being developed and evaluated in this project. Investigators will assess participants every 4 weeks throughout a 24-week intervention period and at 12 weeks after the intervention ends. The primary outcome measure will be buprenorphine treatment adherence during the 24-week intervention. Secondary measures will include buprenorphine treatment engagement (linkage and retention), opioid use, risk of opioid overdose, and post-intervention effects. The project will allow for the development and preliminary evaluation of a novel intervention to promote buprenorphine treatment engagement and adherence in out-of-treatment opioid users. Ultimately, Investigators would like to develop and disseminate an effective and scalable intervention that can enhance office-based buprenorphine treatment and thereby combat the opioid overdose epidemic.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Opioid-use Disorder
Intervention  ICMJE Behavioral: Video DOT+
Participants will receive financial incentives for recording and submitting videos of themselves taking their daily buprenorphine dose.
Study Arms  ICMJE
  • No Intervention: Usual Care
    Participants in this group will be referred to receive office-based buprenorphine treatment
  • Experimental: Video DOT+
    Participants in this group will be referred to receive office-based buprenorphine treatment and will receive financial incentives for taking their daily buprenorphine dose.
    Intervention: Behavioral: Video DOT+
Publications * Not Provided

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 18, 2018)
64
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2023
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • opioid use disorder

Exclusion Criteria:

  • current suicidal/homicidal ideation
  • severe psychiatric disorder
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jackie Hampton 1-866-857-9851 jhampton@jhmi.edu
Contact: August Holtyn 410-550-9691 aholtyn1@jhmi.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03677986
Other Study ID Numbers  ICMJE IRB00186156
R01CE003069-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
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
Plan to Share IPD: No
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Centers for Disease Control and Prevention
Investigators  ICMJE Not Provided
PRS Account Johns Hopkins University
Verification Date February 2021

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