Comparing Treatments for HIV-Infected Opioid and Alcohol Users in an Integrated Care Effectiveness Study (CHOICES)
|ClinicalTrials.gov Identifier: NCT01908062|
Recruitment Status : Completed
First Posted : July 25, 2013
Last Update Posted : October 14, 2015
|Condition or disease||Intervention/treatment||Phase|
|Opioid Use Disorder Alcohol Use Disorder||Drug: Extended Release Naltrexone Other: Treatment As usual||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparing Treatments for HIV-Infected Opioid and Alcohol Users in an Integrated Care Effectiveness Study|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
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
- Treatment initiation [ Time Frame: 4 weeks ]Successful induction onto XR-NTX or initiation of treatment as usual within 4 weeks of randomization.
- Retention on treatment [ Time Frame: 16 weeks ]Percent of expected doses of XR-NTX received or percent of recommended treatment received for TAU arm.
- HIV Outcomes [ Time Frame: 16 weeks ]
- 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 ]
- 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 ]
- 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 ]
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|