NCT03769025

Remote Observed Dosing of Suboxone to Improve Clinical Practice

Completed Phase 1, PHASE2 Results posted Last updated 27 July 2023

What this trial tests

Phase 1, PHASE2 trial testing Suboxone Remote Observed Dosing in Opioid-use Disorder in 16 participants. Completed in 1 July 2022.

Timeline

1 April 2019

Primary endpoint
31 May 2022

1 July 2022

Quick facts

Lead sponsor	University of Pennsylvania
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	16
Start date	1 April 2019
Primary completion	31 May 2022
Estimated completion	1 July 2022
Sites	1 location across United States

Drugs / interventions tested

• Suboxone Remote Observed Dosing
• Suboxone Attention Control

Conditions studied

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

Sponsor

University of Pennsylvania

Who can join

Adults 18 to 45, any sex, with Opioid-use Disorder or Opioid Dependence. 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.

Mean Urinary Buprenorphine Levels Primary · 12 weeks

compare the mean urinary buprenorphine level obtained over 12 weeks between the two groups

Group	Value	95% CI
Remote Observed Dosing	861	± 1656
Attention Control	287	± 253

Percent of Urine Positive Drug Screens Secondary · 12 weeks

Percent of urine drug screens positive for opiates

Group	Value	95% CI
Remote Observed Dosing	.3	± .36
Attention Control	.29	± .49

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 week. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Remote Observed Dosing

Serious: 1/8 (13%)

Deaths: 0/8

Attention Control

Serious: 0/8 (0%)

Deaths: 0/8

Serious adverse events (2 terms)

Reaction	System	Remote Observed Dosing	Attention Control
Diabetic ketoacidosis	Endocrine disorders	—	—
nephrolithiasis	Renal and urinary disorders	—	—

Other adverse events (9 terms — click to expand)

Reaction	System	Remote Observed Dosing	Attention Control
arthralgias	Musculoskeletal and connective tissue disorders	—	—
nausea	Gastrointestinal disorders	—	—
fatigue	General disorders	—	—
upper respiratory infection	Infections and infestations	—	—
Hyperhidrosis	Skin and subcutaneous tissue disorders	—	—
edema	Skin and subcutaneous tissue disorders	—	—
drug withdrawal	General disorders	—	—
skin infection	Skin and subcutaneous tissue disorders	—	—
flushing	Skin and subcutaneous tissue disorders	—	—

Most-reported serious reactions: Diabetic ketoacidosis, nephrolithiasis.

Data from ClinicalTrials.gov NCT03769025 adverse events section.

Sponsor's own description

This is a 15-week, outpatient study of remote observed dosing to improve suboxone compliance in opiate dependent subjects.The main purpose of this study is to see if watching patients take their medication will improve treatment of opiate dependence by prompting patients to take all prescribed doses of Suboxone. Suboxone is approved by the Food and Drug Administration (FDA) for the treatment of opiate dependence. All patients receive a smartphone and patients in the intervention (remote observed dosing) group will use the smartphone to take videos of themselves taking Suboxone.

Publications & conference data

1 peer-reviewed publication 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