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Opioid Partial Agonist

Buprenorphine for Opioid Addiction

Phase 3
Waitlist Available
Led By Elizabeth Ralevski, Ph.D.
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 1-12
Awards & highlights

Study Summary

This trial is testing whether a low or high dose of buprenorphine is more effective in treating opioid dependence in 200 Veteran men and women.

Eligible Conditions
  • Opioid Addiction

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 1-12
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 1-12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Urine Toxicology
Urine Toxicology for Opiate Use

Side effects data

From 2014 Phase 3 trial • 815 Patients • NCT01675167
17%
Nausea
8%
Constipation
7%
Vomiting
7%
Headache
5%
Dizziness
5%
Somnolence
1%
Drug withdrawal syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
OL Buprenorphine HCl Buccal Film
DB Buprenorphine HCl Buccal Film
DB Placebo Film

Trial Design

2Treatment groups
Experimental Treatment
Group I: Buprenorphine low doseExperimental Treatment1 Intervention
Participants in this arm will receive a low dose (less than or equal to 8/2mg) of buprenorphine for 12 weeks.
Group II: Buprenorphine high doseExperimental Treatment1 Intervention
Participants in this arm will receive a high dose (16-24mg) of buprenorphine for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Buprenorphine
2014
Completed Phase 4
~2600

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,847 Previous Clinical Trials
2,737,659 Total Patients Enrolled
3 Trials studying Opioid Addiction
423 Patients Enrolled for Opioid Addiction
United States Department of DefenseFED
861 Previous Clinical Trials
227,185 Total Patients Enrolled
Elizabeth Ralevski, Ph.D.Principal InvestigatorYale University
6 Previous Clinical Trials
97 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Buprenorphine Treatment for Opioid Dependence
2015. "Buprenorphine Treatment for Opioid Dependence". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02187198.
~1 spots leftby Apr 2025
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