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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

Must not have

Cognitive disorders that prevent the participant from passing a study enrollment quiz

Current use of benzodiazepines (such as Valium, Xanax, and other sedatives), either prescribed or illicitly obtained

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Approved for 10 Other Conditions

Pivotal Trial

All Individual Drugs Already Approved

No Placebo-Only Group

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.

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.

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

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I can understand and pass a quiz about the study.

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I am currently using benzodiazepines, like Valium or Xanax.

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I do not have current psychosis or thoughts of harming myself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

opioid use

Secondary study objectives

HIV risk behaviors

criminal activity

health-related quality of life

+4 more

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 4Eligibility criteria met