Comparing Treatments for HIV-Infected Opioid Users in an Integrated Care Effectiveness Study (CHOICES) Scale-Up

NCT03275350 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: Clinical Trials Network-0067
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 5

Brief Summary

The Primary Objective of this study is to compare the effectiveness of HIV clinic-based extended-release Naltrexone (XR-NTX) in decreasing substance use and increasing HIV viral suppression in HIV-infected participants with opioid use disorder to Treatment as Usual in this population.

Conditions

Opioid-use Disorder; Hiv

Outcome Measures

Primary Outcomes (3)

• Number of Participants With HIV Viral Suppression, Missing Imputed as Unsuppressed

  HIV-1 RNA \<200 copies/ml

  12 weeks and 24 weeks

• Number of Participants With HIV Viral Suppression, Complete Case

  HIV-1 RNA \<200 copies/ml

  12 weeks and 24 weeks

• Number of Participants With HIV Viral Suppression, Per-protocol

  HIV-1 RNA \<200 copies/ml

  12 weeks and 24 weeks

Secondary Outcomes (10)

• Veterans Aging Cohort Study (VACS) Index

  Baseline and 24 weeks

• CD4 Count

  Baseline and 24 weeks

• Engagement in HIV Care: Antiretroviral Therapy Prescribed

  Baseline and 24 weeks

• Engagement in HIV Care: 100% Antiretroviral Therapy Adherence

  24 weeks

• Number of Participants With at Least 1 HIV Care Visit in Past 12 Weeks

  24 weeks

Study Arms (2)

XR-NTX

ACTIVE COMPARATOR

Extended-release naltrexone

Drug: Naltrexone Injectable Suspension

TAU

ACTIVE COMPARATOR

Treatment as usual

Other: Treatment as usual

Interventions

Naltrexone Injectable Suspension DRUG

Six monthly injections of extended-release naltrexone

XR-NTX

Treatment as usual OTHER

Standard treatment for opioid use disorder provided at each HIV clinic

TAU

Eligibility Criteria

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

You may qualify if:

• Participant is at least 18 years old
• Participant has provided written informed consent and HIPAA for medical record abstraction
• Participant meets Diagnostic and Statistical (DSM)-5 criteria for moderate or severe opioid use disorder
• Willing to be randomized to antagonist-based therapy or TAU for treatment of opioid use disorder
• Has an HIV viral RNA count of greater than 200 copies/ml (not clinically suppressed)
• Willing to establish ongoing HIV care at the site if not already receiving ongoing care
• If female, willing to take at least one evidence-based measure to avoid becoming pregnant

You may not qualify if:

• Participant has a serious medical, psychiatric, or substance use disorder that, in the opinion of the study physician, would make participation hazardous to the participant, compromise study findings, or prevent participant from completing the study. Examples include:
• Acutely life-threatening medical illnesses (e.g., active opportunistic infection, uncompensated heart failure, end-stage liver disease, acute hepatitis and moderate to severe renal impairment) as assessed by medical history, review of symptoms, physical exam and/or laboratory assessments
• Severe, inadequately treated mental health disorder (e.g., active psychosis, uncontrolled manic-depressive illness) as assessed by history and/or clinical interview
• Suicidal or homicidal ideation requiring immediate attention
• Participant has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) liver enzymes greater than five times the upper limit of normal on screening phlebotomy
• Participant has an international normalized ratio (INR) \> 1.5 or platelet count \<100k
• Participant has a known allergy or sensitivity to naloxone, naltrexone, polyactide-co-glycolide, carboxymethylcellulose, or other components of the Vivitrol diluent
• Anticipate undergoing surgery during study participation
• Have chronic pain requiring ongoing pain management with opioid analgesics
• If female, currently (at time of consent) pregnant or breastfeeding or planning on conceiving in the coming months
• Body habitus that, in the judgment of the study physician, precludes safe intramuscular injection on XR-NTX (e.g., excess fat tissue over the buttocks)
• Received methadone of buprenorphine maintenance therapy for treatment of opioid dependence in the 4 weeks prior to screening
• Have taken an investigational drug in another study within 30 days of study consent
• Have had treatment with XR-NTX for opioid or alcohol dependence in the 4 weeks prior to consent
• Are currently in jail, prison or have a pending legal action which may prevent an individual from completing the study

Sponsors & Collaborators

• Oregon Health and Science University: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Johns Hopkins University: collaborator
• University of Kentucky: collaborator
• Jackson Health System: collaborator
• Tarzana Treatment Centers: collaborator
• Ruth M. Rothstein CORE Center: collaborator

Study Sites (5)

Tarzana Treatment Centers

Tarzana, California, 91356, United States

Location

Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

Ruth M. Rothstein CORE Center

Chicago, Illinois, 60612, United States

Location

University of Kentucky Bluegrass Care Clinic

Lexington, Kentucky, 40536, United States

Location

Johns Hopkins University, Bartlett Specialty Clinic

Baltimore, Maryland, 21287, United States

Location

Related Publications (3)

• 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

• Foot C, Korthuis PT, Tsui JI, Luo SX, Chan B, Cook RR. Associations between stimulant use and return to illicit opioid use following initiation onto medication for opioid use disorder. Addiction. 2024 Jan;119(1):149-157. doi: 10.1111/add.16334. Epub 2023 Sep 15.

  PMID: 37712113 DERIVED

• Hoffman KA, Baker R, Fanucchi LC, Lum PJ, Kunkel LE, Ponce Terashima J, McCarty D, Jacobs P, Korthuis PT. Perspectives on extended-release naltrexone induction among patients living with HIV and opioid use disorder: a qualitative analysis. Addict Sci Clin Pract. 2021 Nov 10;16(1):67. doi: 10.1186/s13722-021-00277-z.

  PMID: 34758887 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders; Acquired Immunodeficiency Syndrome

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

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

korthuis@ohsu.edu

503-494-8044

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: August 28, 2017
• First Posted: September 7, 2017
• Study Start: February 5, 2018
• Primary Completion: November 8, 2019
• Study Completion: November 8, 2019
• Last Updated: April 27, 2022
• Results First Posted: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)