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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
51
The CORE Center
Chicago, Illinois, United States
University of British Columbia
Vancouver, British Columbia, Canada
Number of Participants With Successful Initiation of Treatment Within 4 Weeks of Randomization
Successful induction onto XR-NTX or initiation of treatment as usual within 4 weeks of randomization.
Time frame: 4 weeks
Number of Participants Successfully Retained on Pharmacotherapy Treatment at 16 Weeks
Number of participants who received the maximum possible expected doses of XR-NTX, or the full course of recommended pharmacotherapy treatment for treatment as usual (TAU) arm.
Time frame: 16 weeks
HIV Viral Suppression at 16 Weeks
Plasma HIV viral load of \< 200 copies/mL compared with screening
Time frame: 16 weeks
Mean Days of Opioid Use in Past 30 Days
Change in 30 day opioid use by Addiction Severity Index (ASI)-lite self-report and Time-Line Follow Back in the final 30 days of the 16 week trial compared to screening.
Time frame: Baseline and 16 weeks
HIV Care Engagement
Change in the proportion of participants prescribed antiretroviral therapy (ART) within 16 weeks following randomization, compared to baseline.
Time frame: Baseline and 16 weeks
Participant Safety: Change in Liver Enzymes Between Baseline and Week 16
Change in liver enzymes between screening and Week 16. AST = Aspartate transaminase ALT = Alanine transaminase
Time frame: Baseline and 16 weeks
Number of Participants With Urine Drug Screen (UDS) Positive for Opioids
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Time frame: Baseline and 16 weeks
Mean Days of Alcohol Use in Past 30 Days
Change in 30 day alcohol use by Addiction Severity Index (ASI)-lite self-report and Time-Line Follow Back in the final 30 days of the 16 week trial compared to screening.
Time frame: Baseline and 16 weeks
Number of Participants With Urine Ethyl Glucuronide (EtG) Positive for Alcohol
Time frame: Baseline and 16 weeks
Participant Safety: Any Fatal or Non-fatal Overdose Between Baseline and Week 16
Time frame: 16 weeks
Participant Safety: Precipitated Withdrawal
Proportion of participants assigned to XR-NTX who develop precipitated opioid withdrawal.
Time frame: 16 weeks