Clinical trial NCT03275350: Comparing Treatments for HIV-Infected Opioid Users in an Integrated Care Effectiveness Study (CHOICES) Scale-Up
Official title: Comparing Treatments for HIV-Infected Opioid Users in an Integrated Care Effectiveness Study (CHOICES) Scale-Up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Opioid-use Disorder
Hiv
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Johns Hopkins University
name: University of Kentucky
name: Jackson Health System
name: Tarzana Treatment Centers
name: Ruth M. Rothstein CORE Center
First posted: 2017-09-07
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With HIV Viral Suppression, Missing Imputed as Unsuppressed
timeFrame: 12 weeks and 24 weeks
measure: Number of Participants With HIV Viral Suppression, Complete Case
timeFrame: 12 weeks and 24 weeks
measure: Number of Participants With HIV Viral Suppression, Per-protocol
timeFrame: 12 weeks and 24 weeks
Secondary outcomes:
measure: Veterans Aging Cohort Study (VACS) Index
timeFrame: Baseline and 24 weeks
measure: CD4 Count
timeFrame: Baseline and 24 weeks
measure: Engagement in HIV Care: Antiretroviral Therapy Prescribed
timeFrame: Baseline and 24 weeks
measure: Engagement in HIV Care: 100% Antiretroviral Therapy Adherence
timeFrame: 24 weeks
measure: Number of Participants With at Least 1 HIV Care Visit in Past 12 Weeks
timeFrame: 24 weeks
measure: Number of Participants Who Had Unprotected Sex in Past 30 Days
timeFrame: Baseline and 24 weeks
measure: Number of Participants With Multiple Sex Partners in Past 30 Days
timeFrame: Baseline and 24 weeks
measure: Engagement in HIV Care: Quality of Life
timeFrame: Baseline and 24 weeks
measure: Average Number of Self-Reported Days of Opioid Use in Last 30 Days
timeFrame: Between baseline and 24 weeks
measure: Number of Participants Who Test Positive for Opioids at 24 Weeks
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Tarzana
country: United States
facility: Tarzana Treatment Centers
state: California
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
city: Chicago
country: United States
facility: Ruth M. Rothstein CORE Center
state: Illinois
city: Lexington
country: United States
facility: University of Kentucky Bluegrass Care Clinic
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins University, Bartlett Specialty Clinic
state: Maryland
Study officials:
References:
citation: 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.