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Opioid Partial Agonist

Buprenorphine for Opioid Use Disorder

Phase 3
Recruiting
Research Sponsored by Friends Research Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female, 18-65 years of age, inclusive
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial will compare the effectiveness of a medication given to people on probation or parole to the usual referral to a community treatment program.

Who is the study for?
This trial is for adults aged 18-65 with moderate to severe opioid use disorder who live in Baltimore City and are on parole or probation. They must be able to give consent and stay in the study for at least 4 months. People using benzodiazepines, those with certain medical conditions, pending legal issues, or current enrollment in other substance treatment programs cannot join.Check my eligibility
What is being tested?
The study compares a 'buprenorphine bridge treatment' (BBT) given directly to individuals on probation or parole against the usual practice of referring them to community buprenorphine programs. The goal is to see if BBT helps more people start and stick with treatment.See study design
What are the potential side effects?
Buprenorphine/Naloxone can cause side effects like nausea, headaches, withdrawal symptoms, insomnia, and possible liver damage among others. Each person's experience may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
opioid use
Secondary outcome measures
HIV risk behaviors
criminal activity
health-related quality of life
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: BBTExperimental Treatment1 Intervention
Participants will begin buprenorphine pharmacotherapy using the MedicaSafe buprenorphine dispensing device immediately after an on-site intake at a community supervision office and continue such treatment until they are transitioned to community buprenorphine treatment
Group II: TAUActive Control1 Intervention
Participants will receive a referral to buprenorphine treatment in the community.
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?

Friends Research Institute, Inc.Lead Sponsor
52 Previous Clinical Trials
20,288 Total Patients Enrolled

Media Library

Buprenorphine/Naloxone (Opioid Partial Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT03616236 — Phase 3
Opioid Use Disorder Research Study Groups: BBT, TAU
Opioid Use Disorder Clinical Trial 2023: Buprenorphine/Naloxone Highlights & Side Effects. Trial Name: NCT03616236 — Phase 3
Buprenorphine/Naloxone (Opioid Partial Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03616236 — Phase 3

Frequently Asked Questions

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

How many volunteers will be included in this experiment?

"Presently, this study is not looking for new participants as the last recruitment drive was on August 18th, 2021. The trial was first posted on March 1st, 2019. There are other clinical trials you may be eligible for if you search for studies involving opioids use (146 active trials) or Buprenorphine/Naloxone (60 active trials)."

Answered by AI

Are any minors participating in this research project?

"According to the inclusion criteria, this particular trial is only for patients aged 18-65. However, there are 19 trials available for minors and 173 options for elderly patients."

Answered by AI

Has Buprenorphine/Naloxone been cleared by the FDA?

"There is some evidence from Phase 3 clinical trials to support the efficacy of Buprenorphine/Naloxone, as well as multiple rounds of data collected in order to assess safety. Consequently, our team has rated the safety of this medication a 3."

Answered by AI

What is the primary reason that doctors prescribe Buprenorphine/Naloxone?

"Buprenorphine/Naloxone is a medication used to fight opioid addiction and withdrawal symptoms. It can also provide relief for conditions like pruritus, pain, and septic shock."

Answered by AI

What is the evidence for Buprenorphine/Naloxone's efficacy?

"There are currently 60 clinical trials underway that focus on Buprenorphine/Naloxone. Of those, 14 have advanced to Phase 3 testing. Although the majority of these trials take place in White River Junction, Vermont, there are a total of 243 locations running similar research."

Answered by AI

Are there any medical conditions which would make a person ineligible for this clinical trial?

"Candidates for this study must have a history of opioid use and be between the ages 18-65. Only 320 participants will be accepted in total."

Answered by AI

Are there any unfilled vacancies for candidates in this experiment?

"This specific clinical trial, as indicated by the most recent update on clinicaltrials.gov, is not enrolling patients at this time. The study was first posted on March 1st, 2019 and last edited on August 18th, 2021. There are 206 other trials that are actively recruiting patients right now."

Answered by AI
~164 spots leftby Dec 2025