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Partial Agonist

Pharmacotherapy Strategies for Opioid Use Disorder

Phase 2

Recruiting

Led By Edward V Nunes, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age or older;

Seeking treatment for opioid use disorder and choosing either buprenorphine (BUP) or extended-release injection naltrexone (XR-NTX);

Must not have

18 years of age or older

Timeline

Screening 1 day

Treatment 18 months

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will look at ways to improve treatment for people with opioid addiction, by testing different combinations of drugs and behavioral therapies. The goal is to find out which approaches are most likely to lead to long-term success and help people stay off opioids.

Who is the study for?

Adults with opioid use disorder seeking treatment can join this study. They must be in stable health, speak English, and women should use birth control if applicable. Excluded are those with severe medical or mental conditions, certain substance dependencies, legal constraints that prevent participation, or who have used specific mHealth apps recently.

What is being tested?

The trial is testing combinations of medications like buprenorphine (BUP) and extended-release naltrexone (XR-NTX), along with behavioral strategies to improve retention in treatment for opioid addiction and to determine safe discontinuation methods for long-term success without relapse.

What are the potential side effects?

Possible side effects include reactions related to the medications such as nausea, headaches, dizziness, potential liver damage from naltrexone; buprenorphine may cause respiratory issues or dependency. Behavioral interventions might lead to emotional discomfort.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I am seeking treatment for opioid addiction and considering buprenorphine or naltrexone.

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I am 18 years old or older.

Select...

I am looking for treatment for opioid addiction and considering buprenorphine or naltrexone.

Exclusion Criteria

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

Select...

I am 18 years old or older.

Timeline

Screening ~ 1 day1 visit

Treatment ~ 18 months26 visits

Follow Up ~ 6 months3 visits

Screening ~ 1 day

Treatment ~ 18 months

Follow Up ~6 months

This trial's timeline: 1 day for screening, 18 months for treatment, and 6 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

Discontinuation: Completed Discontinuation without Relapse

Retention: Continuous retention in MOUD treatment at 26 weeks

Secondary study objectives

DSK2: Treatment effectiveness

Discontinuation KS1: Other discontinuation outcomes

Retention KS1: Weekly opioid abstinence

+1 more

Other study objectives

D-Other 10: Sexual risk

D-Other 11: Rate of incarceration

D-Other 12: Rate of homelessness

+31 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

16Treatment groups

Experimental Treatment

Group I: Retention: XR-NTX + MMRExperimental Treatment2 Interventions

Extended-release injectable naltrexone (XR-NTX) plus MMR, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component.

Group II: Retention: XR-NTX + MMExperimental Treatment2 Interventions

Extended-release injectable naltrexone (XR-NTX) plus MM, consisting of standard Medical Management and usual counseling at the treatment program.

Group III: Retention: XR-BUP + MMRExperimental Treatment2 Interventions

Extended-release injectable buprenorphine (XR-BUP) plus MMR, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component.

Group IV: Retention: XR-BUP + MMExperimental Treatment2 Interventions

Extended-release injectable buprenorphine (XR-BUP) plus MM, consisting of standard Medical Management and usual counseling at the treatment program.

Group V: Retention: SL-BUP standard dose + MMRExperimental Treatment2 Interventions

Standard dose sublingual buprenorphine-naloxone (SL-BUP) 16mg/day target plus MMR, consisting of Medical Management and usual counseling, plus a technology-based behavioral component.

Group VI: Retention: SL-BUP standard dose + MMExperimental Treatment2 Interventions

Standard dose sublingual buprenorphine-naloxone (SL-BUP) 16mg/day target plus MM, consisting of standard Medical Management and usual counseling at the treatment program.

Group VII: Retention: SL-BUP high dose + MMRExperimental Treatment2 Interventions

High dose sublingual buprenorphine-naloxone (SL-BUP) 32mg/day target plus MMR, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component.

Group VIII: Retention: SL-BUP high dose + MMExperimental Treatment2 Interventions

High dose sublingual buprenorphine-naloxone (SL-BUP) 32mg/day target plus MM, consisting of standard Medical Management and usual counseling at the treatment program.

Group IX: Discontinuation: Discontinue XR-NTX with XR-NTX + MMDExperimental Treatment2 Interventions

Start on XR-NTX, taper with XR-NTX, plus MMD, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component.

Group X: Discontinuation: Discontinue XR-NTX with XR-NTX + MMExperimental Treatment2 Interventions

Start on XR-NTX, taper with XR-NTX, plus MM, consisting of standard Medical Management and usual counseling at the treatment program.

Group XI: Discontinuation: Discontinue XR-BUP with XR-BUP + MMDExperimental Treatment2 Interventions

Start on XR-BUP, taper with XR-BUP, plus MMD, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component.

Group XII: Discontinuation: Discontinue XR-BUP with XR-BUP + MMExperimental Treatment2 Interventions

Start on XR-BUP, taper with XR-BUP, plus MM, consisting of standard Medical Management and usual counseling at the treatment program.

Group XIII: Discontinuation: Discontinue SL-BUP with XR-BUP + MMDExperimental Treatment2 Interventions

Start on SL-BUP, taper with XR-BUP, plus MMD, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component.

Group XIV: Discontinuation: Discontinue SL-BUP with XR-BUP + MMExperimental Treatment2 Interventions

Start on SL-BUP, taper with XR-BUP, plus MM, consisting of standard Medical Management and usual counseling at the treatment program.

Group XV: Discontinuation: Discontinue SL-BUP with SL-BUP + MMDExperimental Treatment2 Interventions

Start on SL-BUP, taper with SL-BUP, plus MMD, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component.

Group XVI: Discontinuation: Discontinue SL-BUP with SL-BUP + MMExperimental Treatment2 Interventions

Start on SL-BUP, taper with SL-BUP, plus MM, consisting of standard Medical Management and usual counseling at the treatment program.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

2017

N/A

~500

MMR

2006

Completed Phase 3