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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-05

Study Completion Date

2019-11-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Naltrexone for Opioid Dependent Released Human Immunodeficiency Virus Positive (HIV+) Criminal Justice Populations

NCT01246401

HIV AIDS Opioid Dependence +1 more

COMPLETED PHASE1/PHASE2

Opioid Relapse & HIV Risk: 48 Versus 24 Weeks of Injectable Extended Release Naltrexone

NCT01882361

Opiate Dependence Human Immunodeficiency Virus

COMPLETED PHASE2/PHASE3

Intermittent Naltrexone Among Polysubstance Users

NCT01723384

Methamphetamine Alcohol

COMPLETED PHASE2

Naltrexone for Overdose Prevention

NCT06633900

Overdose Accidental

RECRUITING PHASE2/PHASE3

Extended-release Buprenorphine Compared to Sublingual Buprenorphine in Rural Settings (RXR)

NCT06023459

ACTIVE_NOT_RECRUITING PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The CTN-0055 CHOICES pilot study demonstrated the feasibility of extended-release naltrexone (XR-NTX) for treatment of opioid use disorder in HIV primary care. The CTN-0067 CHOICES scale-up study builds on lessons learned from the pilot and uses the Consolidated Framework for Implementation Research to advance understanding of XR-NTX adoption in HIV primary care clinics. The study is an open-label, randomized, comparative effectiveness trial of office-based XR-NTX for 24 weeks (6 monthly injections) versus treatment as usual (TAU) in HIV-infected participants with untreated opioid use disorder. Each participant will be engaged in the overall study for 25 to 28 weeks, depending on the speed of screening and enrollment procedures.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Opioid-use Disorder Hiv

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

XR-NTX

Extended-release naltrexone

Group Type ACTIVE_COMPARATOR

Naltrexone Injectable Suspension

Intervention Type DRUG

Six monthly injections of extended-release naltrexone

TAU

Treatment as usual

Group Type ACTIVE_COMPARATOR

Treatment as usual

Intervention Type OTHER

Standard treatment for opioid use disorder provided at each HIV clinic

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Naltrexone Injectable Suspension

Six monthly injections of extended-release naltrexone

Intervention Type DRUG

Treatment as usual

Standard treatment for opioid use disorder provided at each HIV clinic

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No