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Buprenorphine Treatment Engagement and Overdose Prevention

Buprenorphine Treatment Engagement and Overdose Prevention in Opioid Users

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03677986
Enrollment
41
Registered
2018-09-19
Start date
2019-05-01
Completion date
2020-10-20
Last updated
2024-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid-use Disorder

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.

Interventions

BEHAVIORALVideo DOT+

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

Sponsors

Centers for Disease Control and Prevention
CollaboratorFED
Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* opioid use disorder

Exclusion criteria

* current suicidal/homicidal ideation * severe psychiatric disorder

Design outcomes

Primary

MeasureTime frameDescription
Buprenorphine Treatment Adherence24 weeksThis will be assessed by the percentage of buprenorphine-positive urine samples during the 24-week intervention.

Secondary

MeasureTime frameDescription
Linkage to Treatment24 weeksThis will be assessed by the percentage of participants who get linked to buprenorphine treatment during the 24-week intervention

Countries

United States

Participant flow

Recruitment details

Participants were recruited via community agencies that served the target population and a referral system in which study participants were paid for successfully referring others to the study. Interested individuals completed a brief phone interview. Potentially eligible participants were invited for a full in-person interview.

Participants by arm

ArmCount
Usual Care
Participants in this group will be referred to receive office-based buprenorphine treatment
20
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. Video DOT+: Participants will receive financial incentives for recording and submitting videos of themselves taking their daily buprenorphine dose.
21
Total41

Baseline characteristics

CharacteristicUsual CareVideo DOT+Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
20 Participants21 Participants41 Participants
Age, Continuous49.3 years
STANDARD_DEVIATION 8.9
44.6 years
STANDARD_DEVIATION 11.4
46.9 years
STANDARD_DEVIATION 10.2
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants0 Participants2 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
17 Participants11 Participants28 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
1 Participants10 Participants11 Participants
Region of Enrollment
United States
20 Participants21 Participants41 Participants
Self-reported methadone use6 Participants12 Participants18 Participants
Sex: Female, Male
Female
14 Participants16 Participants30 Participants
Sex: Female, Male
Male
6 Participants5 Participants11 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 200 / 21
other
Total, other adverse events
0 / 200 / 21
serious
Total, serious adverse events
0 / 200 / 21

Outcome results

Primary

Buprenorphine Treatment Adherence

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

Time frame: 24 weeks

ArmMeasureValue (MEAN)Dispersion
Usual CareBuprenorphine Treatment Adherence19.7 percentage of urine samplesStandard Deviation 4
Video DOT+Buprenorphine Treatment Adherence16.1 percentage of urine samplesStandard Deviation 3.7
p-value: 0.91495% CI: [0.21, 4.14]GEE
Secondary

Linkage to Treatment

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

Time frame: 24 weeks

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026