Cabotegravir + Buprenorphine for Opioid Use Disorder

(NOTRE Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Lauren Brinkley-Rubinstein, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Duke University

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The investigators plan to conduct an R61/33 hybrid type 2 implementation-effectiveness trial that includes 1) a one-year exploratory R61 phase that will enable the development of the intervention protocol needed for the R33 trial phase including concrete R61 phase milestones; 2) a four-year R33 phase that will include a concurrent implementation evaluation and a randomized control trial.

Research Team

Lauren Brinkley-Rubinstein, PhD

Principal Investigator

Duke University

Eligibility Criteria

This trial is for individuals with opioid use disorder, at risk of HIV infection or have a prescription drug abuse history. It's also open to those who may develop cataracts as a result of their condition or treatment. Participants must meet certain health criteria not specified here.

Inclusion Criteria

HIV negative as confirmed by a HIV rapid test

Eligible for release within 120 days (sentenced and/or pretrial) excluding individuals who might be sentenced to federal prison

History of OUD meeting DSM-5 criteria of moderate or severe opioid use disorder at the time of incarceration or treated in an opioid agonist treatment program during the year before incarceration or met OUD criteria in the year prior to incarceration

Exclusion Criteria

Untreated psychiatric disorder that may make participation hazardous such as untreated psychosis (treated psychiatric disorders allowed)

Suicidal ideation

I do not have any severe illnesses like unstable diabetes, heart disease, or liver problems.

Treatment Details

Interventions

• Buprenorphine (Anti-tumor antibiotic)
• Cabotegravir (Virus Therapy)

Trial Overview The study tests long-acting pre-exposure prophylaxis (PrEP) and medications for opioid use disorder in carceral settings. It compares injections and pills of Cabotegravir and Buprenorphine over five years, including an initial one-year exploratory phase followed by a four-year randomized control trial.

Participant Groups

Group I: Long Acting Injectable Arm Experimental Treatment 2 Interventions

Participants assigned to this arm will be administered the-long acting injectable formulation of pre-exposure prophylaxis every 1-2 months, as well as the long-acting injectable formulation of buprenorphine, at the same clinic visit.

Group II: Daily Oral Pill Arm Active Control 2 Interventions

Participants assigned to this arm will be administered daily oral pre-exposure prophylaxis for HIV prevention, as well as daily oral buprenorphine for opioid use disorder

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Mary E. Klotman

Duke University

Chief Executive Officer since 2017

MD from Duke University School of Medicine

Michelle McMurry-Heath

Duke University

Chief Medical Officer since 2020

MD from Duke University School of Medicine

Friends Research Institute, Inc.

Collaborator

Trials

60

Recruited

22,500+

Dr. Steven Carswell

Friends Research Institute, Inc.

Chief Executive Officer

PhD

Dr. Robert Schwartz

Friends Research Institute, Inc.

Chief Medical Officer since 2023

MD

The Miriam Hospital

Collaborator

Trials

252

Recruited

39,200+

Maria Ducharme

The Miriam Hospital

Chief Executive Officer since 2021

Doctor of Nursing Practice from Massachusetts General Hospital Institute of Health Professions, MS in Nursing from University of Rhode Island, BS in Nursing from Rhode Island College

Mark A. Deitch

The Miriam Hospital

Chief Medical Officer

MD, MBA

University of Arkansas

Collaborator

Trials

500

Recruited

153,000+

Dr. Brent D. Williams

University of Arkansas

Chief Executive Officer since 2023

Ph.D. in Business Administration from the University of Arkansas

Dr. Racheal Adams

University of Arkansas

Chief Medical Officer since 2023

Doctor of Pharmacy from the University of Arkansas for Medical Sciences

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Executive Officer since 2003

MD from National Autonomous University of Mexico

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Medical Officer since 2003

MD from National Autonomous University of Mexico