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Remote Observed Dosing of Suboxone to Improve Clinical Practice

NCT03769025 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-07-27

Study results available
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Summary

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.

Conditions

  • Opioid-use Disorder
  • Opioid Dependence
  • Opiate Dependence

Interventions

BEHAVIORAL

Suboxone Remote Observed Dosing

The remote observed dosing group will use the provided smartphone to video record themselves taking their Suboxone dose each day

OTHER

Suboxone Attention Control

Attention control group will send a text message daily confirming that they have taken their Suboxone dose

Sponsors & Collaborators

Principal Investigators

  • Kyle Kampman, MD · University of Pennsylvania

  • Brenda Curtis, PhD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2022-05-31
Completion
2022-07-01

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03769025 on ClinicalTrials.gov