Comparing Treatments for HIV-Infected Opioid and Alcohol Users in an Integrated Care Effectiveness Study (CHOICES)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|