Comparing Treatments for HIV-Infected Opioid and Alcohol Users in an Integrated Care Effectiveness Study

NCT01908062 | Completed Phase 3 Results DMC

• 2 other identifiers: NIDA-CTN-0055U10DA015815
• Study Type: interventional
• Target: 51
• Locations: 2 countries
• Sites: 2

Brief Summary

The purpose of this study is to learn how best to treat substance use disorders in an HIV clinic setting. Specifically, the purpose of this pilot study is to learn if extended-release naltrexone (XR-NTX) would be a feasible and acceptable treatment for HIV-infected individuals with opioid or alcohol use disorders.

Conditions

Opioid Use Disorder; Alcohol Use Disorder

Keywords

Substance related disorders; HIV; naltrexone

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Successful Initiation of Treatment Within 4 Weeks of Randomization

  Successful induction onto XR-NTX or initiation of treatment as usual within 4 weeks of randomization.

  4 weeks

• Number of Participants Successfully Retained on Pharmacotherapy Treatment at 16 Weeks

  Number of participants who received the maximum possible expected doses of XR-NTX, or the full course of recommended pharmacotherapy treatment for treatment as usual (TAU) arm.

  16 weeks

Secondary Outcomes (9)

• HIV Viral Suppression at 16 Weeks

  16 weeks

• Mean Days of Opioid Use in Past 30 Days

  Baseline and 16 weeks

• HIV Care Engagement

  Baseline and 16 weeks

• Participant Safety: Change in Liver Enzymes Between Baseline and Week 16

  Baseline and 16 weeks

• Number of Participants With Urine Drug Screen (UDS) Positive for Opioids

  Baseline and 16 weeks

Study Arms (2)

Treatment as Usual

ACTIVE COMPARATOR

The current standard of care for treatment of opioid use disorders in HIV clinics is opioid agonist therapy. HIV-infected patients with alcohol use disorders are typically referred for residential, outpatient, and self-help groups.

Other: Treatment As usual

Extended Release Naltrexone

EXPERIMENTAL

Extended release naltrexone (XR-NTX), delivered by monthly injection. Dose: 380 mg. Frequency: One injection per month, for four months. Duration: 30 days.

Drug: Extended Release Naltrexone

Interventions

Extended Release Naltrexone DRUG

Also known as: Vivitrol

Extended Release Naltrexone

Treatment As usual OTHER

Treatment as Usual

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet Diagnostic and Statistical Manual (DSM-5) criteria for moderate or severe opioid use disorder and/or alcohol use disorder.
• Be willing to be randomized to antagonist-based therapy or treatment as usual (TAU) for treatment of opioid and/or alcohol use disorders.
• Be HIV-infected as defined by history of positive HIV serology or HIV RNA pcr \>10,000 copies/mL).
• Be willing to establish ongoing HIV care at community treatment program(CTP) if not already receiving ongoing care.
• Be willing to initiate antiretroviral therapy (ART) if not already prescribed ART, regardless of CD4 count.
• Be at least 18 years old.
• Be able to provide written informed consent and HIPAA (if applicable) for medical record abstraction.
• Be able to communicate in English.
• If female, be willing to take measures to avoid becoming pregnant.

You may not qualify if:

• Individuals will be excluded from pilot study participation if they:
• Have a serious medical, psychiatric or substance use disorder that, in the opinion of the study physician, would make study participation hazardous to the participant, compromise study findings, or prevent the participant from completing the study.
• Examples include:
• Disabling or terminal medical illness (e.g., active opportunistic infection, uncompensated heart failure, cirrhosis or end-stage liver disease, acute hepatitis and moderate to severe renal impairment) as assessed by medical history, review of systems, physical exam and/or laboratory assessments;
• Severe, untreated or inadequately treated mental health disorder (e.g., active psychosis, uncontrolled manic-depressive illness) as assessed by history and/or clinical interview;
• Current severe benzodiazepine or other depressant or sedative hypnotic use requiring medical detoxification;
• Suicidal or homicidal ideation requiring immediate attention.
• Have aspartate aminotransferase (AST) or alanine aminotransferase (ALT) liver enzymes greater than 5 times upper limit of normal on screening phlebotomy. Results from tests conducted within the past 30 days which are abstracted from medical record information are acceptable.
• Have international normalized ratio (INR) \> 1.5 or platelet count \<100k. Results from tests conducted within the past 30 days which are abstracted from medical record information are acceptable.
• Have known allergy or sensitivity to naloxone, naltrexone, polylactide-co-glycolide, carboxymethylcellulose, or other components of the Vivitrol® diluents.
• Anticipate undergoing surgery during study participation.
• Have chronic pain requiring ongoing pain management with opioid analgesics.
• Pending legal action or other reasons that might prevent an individual from completing the study.
• Currently pregnant or breastfeeding.
• Body habitus that, in the judgment of the study physician, precludes safe intramuscular injection of XR-NTX, (e.g. excess fat tissue over the buttocks).

Sponsors & Collaborators

• Oregon Health and Science University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

The CORE Center

Chicago, Illinois, 60612, United States

Location

University of British Columbia

Vancouver, British Columbia, Canada

Location

Related Publications (2)

• Kornor H, Lobmaier PPK, Kunoe N. Sustained-release naltrexone for opioid dependence. Cochrane Database Syst Rev. 2025 May 9;5(5):CD006140. doi: 10.1002/14651858.CD006140.pub3.

  PMID: 40342086 DERIVED

• Korthuis PT, Lum PJ, Vergara-Rodriguez P, Ahamad K, Wood E, Kunkel LE, Oden NL, Lindblad R, Sorensen JL, Arenas V, Ha D, Mandler RN, McCarty D; CTN-0055 CHOICES Investigators. Feasibility and safety of extended-release naltrexone treatment of opioid and alcohol use disorder in HIV clinics: a pilot/feasibility randomized trial. Addiction. 2017 Jun;112(6):1036-1044. doi: 10.1111/add.13753. Epub 2017 Feb 8.

  PMID: 28061017 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders; Alcoholism; Substance-Related Disorders

Interventions

vivitrol; Therapeutics

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Alcohol-Related Disorders

Results Point of Contact

• Title: Todd Korthuis
• Organization: Oregon Health & Science University

korthuis@ohsu.edu

503-494-8044

Study Officials

• Philip T Korthuis, MD, MPH

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: July 23, 2013
• First Posted: July 25, 2013
• Study Start: June 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 19, 2019
• Results First Posted: February 26, 2019

Record last verified: 2019-03

Locations

CA (1); US (1)