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Suboxone Remote Observed Dosing for Opioid Use Disorder

Phase 1 & 2
Waitlist Available
Led By Brenda Curtis, PhD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

This study is evaluating whether a smartphone app can help improve compliance with medication for opiate dependence.

Eligible Conditions
  • Opioid Use Disorder
  • Opioid Addiction

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Urinary Buprenorphine Levels
Secondary outcome measures
Percent of Urine Positive Drug Screens

Side effects data

From 2022 Phase 1 & 2 trial • 16 Patients • NCT03769025
25%
upper respiratory infection
25%
Hyperhidrosis
25%
nausea
25%
arthralgias
25%
fatigue
13%
flushing
13%
skin infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Attention Control
Remote Observed Dosing

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Remote Observed DosingExperimental Treatment1 Intervention
One group will be assigned to Remote Observed Dosing (ROD) and will have all of their Suboxone® doses remotely observed. The intervention is remote observed dosing
Group II: Attention ControlActive Control1 Intervention
The attention control (AC) group will not have their dosing observed but will send a text message confirming they have taken their study medication to the study team daily matching contact with the study team. Text message confirming that they have taken their study medication is the intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Suboxone Remote Observed Dosing
2019
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,470 Previous Clinical Trials
2,619,715 Total Patients Enrolled
University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,882,267 Total Patients Enrolled
Brenda Curtis, PhDPrincipal InvestigatorUniversity of Pennsylvania

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
University of Pennsylvania Treatment Research Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Remote Observed Dosing of Suboxone to Improve Clinical Practice
Kyle Kampman 2019. "Remote Observed Dosing of Suboxone to Improve Clinical Practice". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03769025.
~3 spots leftby Apr 2025
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