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Buprenorphine Treatment Engagement and Overdose Prevention

Primary Purpose

Opioid-use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Video DOT+
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-use Disorder

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • opioid use disorder

Exclusion Criteria:

  • current suicidal/homicidal ideation
  • severe psychiatric disorder

Sites / Locations

  • Center for Learning and HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

Video DOT+

Arm Description

Participants in this group will be referred to receive office-based buprenorphine treatment

Participants in this group will be referred to receive office-based buprenorphine treatment and will receive financial incentives for taking their daily buprenorphine dose.

Outcomes

Primary Outcome Measures

Buprenorphine treatment adherence
This will be assessed by the percentage of buprenorphine-positive urine samples during the 24-week intervention

Secondary Outcome Measures

Linkage to treatment
This will be assessed by the percentage of participants who get linked to buprenorphine treatment during the 24-week intervention

Full Information

First Posted
September 18, 2018
Last Updated
May 6, 2022
Sponsor
Johns Hopkins University
Collaborators
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT03677986
Brief Title
Buprenorphine Treatment Engagement and Overdose Prevention
Official Title
Mobile Technology for Buprenorphine Treatment Engagement and Overdose Prevention in Opioid Users
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 22, 2019 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Participants in this group will be referred to receive office-based buprenorphine treatment
Arm Title
Video DOT+
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Video DOT+
Intervention Description
Participants will receive financial incentives for recording and submitting videos of themselves taking their daily buprenorphine dose.
Primary Outcome Measure Information:
Title
Buprenorphine treatment adherence
Description
This will be assessed by the percentage of buprenorphine-positive urine samples during the 24-week intervention
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Linkage to treatment
Description
This will be assessed by the percentage of participants who get linked to buprenorphine treatment during the 24-week intervention
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: opioid use disorder Exclusion Criteria: current suicidal/homicidal ideation severe psychiatric disorder
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jackie Hampton
Phone
1-866-857-9851
Email
jhampton@jhmi.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kenneth Silverman, Ph.D.
Phone
410-550-2694
Email
ksilverm@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Silverman, Ph.D.
Organizational Affiliation
Johns Hopkins School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Learning and Health
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jackie Hampton
Phone
866-857-9851
Email
jhampton@jhmi.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34323526
Citation
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.
Results Reference
derived

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Buprenorphine Treatment Engagement and Overdose Prevention

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