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Opioid Agonist

Interim Buprenorphine Treatment for Opioid Use Disorder

Phase 2
Waitlist Available
Research Sponsored by University of Vermont
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For inclusion, participants must be >=18 years old, in good health, meet DSM-V criteria for opioid use disorder, provide an opioid-positive urine and be currently waitlisted with a community opioid treatment clinic or provider.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

This trial will compare the effectiveness of a new interim treatment for opioid dependence to waiting for conventional treatment.

Eligible Conditions
  • Opioid Use Disorder

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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
Illicit opioid abstinence

Side effects data

From 2014 Phase 3 trial • 313 Patients • NCT01848054
8%
Nausea (Induction)
7%
Headache (Induction)
5%
Vomiting (Induction)
4%
Insomnia (Induction)
1%
Diabetic ketoacidosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
BNX Sublingual Tablets Induction
Buprenorphine Induction

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Interim Buprenorphine TreatmentExperimental Treatment1 Intervention
Interim Buprenorphine Treatment includes (a) Maintenance treatment with Buprenorphine/ naloxone sublingual tablets with bi-monthly clinic visits for observed dosing and the remaining doses dispensed at home via a secure computerized portable device (Med-O-Wheel, Addoz, Finland). (b) nightly calls from an automated Interactive Voice Response (IVR) phone system to assess any drug use, withdrawal and craving, (c) IVR-generated random call-backs for urinalysis and pill counts, and (d) HIV+Hepatitis education delivered via iPad. (e) monthly follow-up assessments
Group II: Waitlist ControlActive Control1 Intervention
Waitlist Control participants will remain on the waitlist for their treatment of choice but complete the same monthly assessments.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naloxone
FDA approved

Find a Location

Who is running the clinical trial?

University of VermontLead Sponsor
266 Previous Clinical Trials
3,743,591 Total Patients Enrolled

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 site did they apply to?
University of Vermont
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Ive tried a number of different thing and im tryibg to deside what to do in the future need a little help.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Interim Buprenorphine Treatment to Bridge Waitlist Delays: Stage II Evaluation
Stacey C. Sigmon 2018. "Interim Buprenorphine Treatment to Bridge Waitlist Delays: Stage II Evaluation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03420313.
All > Probuphine
~14 spots leftby Apr 2025
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