Comparing Treatments for HIV-Infected Opioid and Alcohol Users in an Integrated Care Effectiveness Study (CHOICES)
The purpose of this study is to learn how best to treat substance use disorders in an HIV clinic setting. Specifically, the purpose is to learn if extended-release naltrexone (XR-NTX) would be an effective and acceptable treatment for HIV-infected individuals with opioid or alcohol use disorders.
Opioid Use Disorder
Alcohol Use Disorder
Drug: Extended Release Naltrexone
Other: Treatment As usual
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Comparing Treatments for HIV-Infected Opioid and Alcohol Users in an Integrated Care Effectiveness Study|
- Treatment initiation [ Time Frame: One month ] [ Designated as safety issue: No ]Successful induction onto extended release naltrexone or initiation of treatment as usual within 1 month of randomization.
- Retention on treatment [ Time Frame: 4 months ] [ Designated as safety issue: No ]4 extended release naltrexone injections
- HIV RNA suppression [ Time Frame: 4 months ] [ Designated as safety issue: No ]Plasma HIV viral load of < 200 copies/mL
- Substance use [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- Change in 30 day opioid abstinence (by Addiction Severity Index (ASI)-lite self-report and urine drug screen (UDS) confirmation) in the final 30 days of the 16 week trial compared to baseline.
- Change in past 30-day alcohol and other drug use by ASI-lite and UDS at 16 weeks, compared with baseline.
- Number of medical management visits attended, measured at 16 weeks post- randomization.
- HIV Care Engagement [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- Change in the proportion of participants prescribed antiretroviral therapy (ART) within 16 weeks following randomization, compared to baseline.
- Proportion of participants taking 100% of prescribed ART doses in the past 3 days at 16 weeks for those prescribed ART at any point during the 16 week trial.
- Number of HIV primary care visits at 16 weeks.
- Participant Safety [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
- Percent of subjects with precipitated withdrawal, hepatotoxicity, or overdose.
- Change in liver enzymes between baseline and 16-week follow-up.
- Change in Beck Depression Inventory score at 16 weeks compared to baseline.
|Study Start Date:||February 2014|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Treatment as Usual
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|
Experimental: Extended Release Naltrexone
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
Other Name: Vivitrol
|Contact: Philip T Korthuis, MD, MPHfirstname.lastname@example.org|
|Contact: Lynn Kunkel, MSemail@example.com|
|Canada, British Columbia|
|University of British Columbia||Not yet recruiting|
|Vancouver, British Columbia, Canada|
|Contact: Evan Wood, MD, PhD|
|Principal Investigator: Evan Wood, MD, PhD|
|Principal Investigator:||Philip T Korthuis, MD, MPH||Oregon Health and Science University|