Comparing Treatments for HIV-Infected Opioid Users in an Integrated Care Effectiveness Study (CHOICES) Scale-Up
Overview
- Phase
- Phase 2
- Intervention
- Naltrexone Injectable Suspension
- Conditions
- Opioid-use Disorder
- Sponsor
- Oregon Health and Science University
- Enrollment
- 114
- Locations
- 5
- Primary Endpoint
- Number of Participants With HIV Viral Suppression, Per-protocol
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
P. Todd Korthuis, MD
Professor of Medicine
Oregon Health and Science University
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
Arms & Interventions
XR-NTX
Extended-release naltrexone
Intervention: Naltrexone Injectable Suspension
TAU
Treatment as usual
Intervention: Treatment as usual
Outcomes
Primary Outcomes
Number of Participants With HIV Viral Suppression, Per-protocol
Time Frame: 12 weeks and 24 weeks
HIV-1 RNA \<200 copies/ml
Number of Participants With HIV Viral Suppression, Missing Imputed as Unsuppressed
Time Frame: 12 weeks and 24 weeks
HIV-1 RNA \<200 copies/ml
Number of Participants With HIV Viral Suppression, Complete Case
Time Frame: 12 weeks and 24 weeks
HIV-1 RNA \<200 copies/ml
Secondary Outcomes
- Veterans Aging Cohort Study (VACS) Index(Baseline and 24 weeks)
- CD4 Count(Baseline and 24 weeks)
- Number of Participants With Multiple Sex Partners in Past 30 Days(Baseline and 24 weeks)
- Number of Participants With at Least 1 HIV Care Visit in Past 12 Weeks(24 weeks)
- Engagement in HIV Care: Quality of Life(Baseline and 24 weeks)
- Number of Participants Who Had Unprotected Sex in Past 30 Days(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 Who Test Positive for Opioids at 24 Weeks(24 weeks)
- Average Number of Self-Reported Days of Opioid Use in Last 30 Days(Between baseline and 24 weeks)