Opioid-use Disorder
Conditions
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
Participants will receive financial incentives for recording and submitting videos of themselves taking their daily buprenorphine dose.
Sponsors
Study design
Eligibility
Inclusion criteria
* opioid use disorder
Exclusion criteria
* current suicidal/homicidal ideation * severe psychiatric disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Buprenorphine Treatment Adherence | 24 weeks | This will be assessed by the percentage of buprenorphine-positive urine samples during the 24-week intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Linkage to Treatment | 24 weeks | This 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
| Arm | Count |
|---|---|
| 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 |
| Total | 41 |
Baseline characteristics
| Characteristic | Usual Care | Video DOT+ | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 21 Participants | 41 Participants |
| Age, Continuous | 49.3 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 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants | 11 Participants | 28 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 10 Participants | 11 Participants |
| Region of Enrollment United States | 20 Participants | 21 Participants | 41 Participants |
| Self-reported methadone use | 6 Participants | 12 Participants | 18 Participants |
| Sex: Female, Male Female | 14 Participants | 16 Participants | 30 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 21 |
| other Total, other adverse events | 0 / 20 | 0 / 21 |
| serious Total, serious adverse events | 0 / 20 | 0 / 21 |
Outcome results
Buprenorphine Treatment Adherence
This will be assessed by the percentage of buprenorphine-positive urine samples during the 24-week intervention.
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Buprenorphine Treatment Adherence | 19.7 percentage of urine samples | Standard Deviation 4 |
| Video DOT+ | Buprenorphine Treatment Adherence | 16.1 percentage of urine samples | Standard Deviation 3.7 |
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