Buprenorphine Treatment Engagement and Overdose Prevention

NCT ID: NCT03677986

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2020-10-20

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.

Conditions

Opioid-use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Usual Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Video DOT+

Intervention Type: BEHAVIORAL

Participants will receive financial incentives for recording and submitting videos of themselves taking their daily buprenorphine dose.

Interventions

Video DOT+

Participants will receive financial incentives for recording and submitting videos of themselves taking their daily buprenorphine dose.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• opioid use disorder

Exclusion Criteria

• current suicidal/homicidal ideation
• severe psychiatric disorder

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenneth Silverman, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Medicine

Locations

Center for Learning and Health

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34323526 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01CE003069-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00186156

Identifier Type: -

Identifier Source: org_study_id