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 of this pilot study is to learn if extended-release naltrexone (XR-NTX) would be a feasible 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: 4 weeks ] [ Designated as safety issue: No ]Successful induction onto XR-NTX or initiation of treatment as usual within 4 weeks of randomization.
- Retention on treatment [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Percent of expected doses of XR-NTX received or percent of recommended treatment received for TAU arm.
- HIV Outcomes [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Plasma HIV viral load of < 200 copies/mL compared with screening
- Change in CD4 count compared with screening
- Substance Use Outcomes [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Change in 30 day opioid abstinence (by Addiction Severity Index (ASI)-lite self-report, Time-Line Follow Back, and urine drug screen (UDS) confirmation) in the final 30 days of the 16 week trial compared to screening.
- Change in past 30-day alcohol and other drug use by ASI-lite, Time-line Follow Back, and UDS at 16 weeks, compared with screening.
- HIV Care Engagement [ Time Frame: 16 weeks ] [ 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: 16 weeks ] [ Designated as safety issue: Yes ]
- Change in liver enzymes between screening and Week 16.
- Any fatal and non-fatal overdose between screening and Week 16.
- Change in Concise Health Risk Tracking score between screening and Week 16.
- Proportion of participants assigned to XR-NTX who develop precipitated opioid withdrawal.
|Study Start Date:||June 2014|
|Study Completion Date:||March 2015|
|Primary Completion Date:||March 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01908062
|United States, Illinois|
|The CORE Center|
|Chicago, Illinois, United States, 60612|
|Canada, British Columbia|
|University of British Columbia|
|Vancouver, British Columbia, Canada|
|Principal Investigator:||Philip T Korthuis, MD, MPH||Oregon Health and Science University|