NCT03677986

Buprenorphine Treatment Engagement and Overdose Prevention

Completed NA Results posted Last updated 20 February 2024

What this trial tests

NA trial testing Video DOT+ in Opioid-use Disorder in 41 participants. Completed in 20 October 2020.

Timeline

1 May 2019

Primary endpoint
28 July 2020

20 October 2020

Quick facts

Lead sponsor	Johns Hopkins University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	41
Start date	1 May 2019
Primary completion	28 July 2020
Estimated completion	20 October 2020
Sites	1 location across United States

Drugs / interventions tested

• Video DOT+

Conditions studied

• Opioid-use Disorder — all drugs for Opioid-use Disorder →

Sponsor

Johns Hopkins University

Who can join

Adults 18 to 100, any sex, with Opioid-use Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Buprenorphine Treatment Adherence Primary · 24 weeks

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

Group	Value	95% CI
Usual Care	19.7	± 4.0
Video DOT+	16.1	± 3.7

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Adjunct interventions to standard medical management of buprenorphine in outpatient settings: A systematic review of the evidence.
   Wyse JJ, Morasco BJ, Dougherty J, Edwards B, et al · · 2021 · cited 19× · PMID 34508958 · DOI 10.1016/j.drugalcdep.2021.108923
2. Remotely delivered incentives to promote buprenorphine treatment engagement in out-of-treatment adults with opioid use disorder.
   Holtyn AF, Toegel F, Novak MD, Leoutsakos JM, et al · · 2021 · cited 10× · PMID 34087746 · DOI 10.1016/j.drugalcdep.2021.108786
3. Technology-assisted opioid education for out-of-treatment adults with opioid use disorder.
   Toegel F, Novak MD, Rodewald AM, Leoutsakos JM, et al · · 2022 · cited 3× · PMID 34323526 · DOI 10.1037/adb0000769