- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03275350
Comparing Treatments for HIV-Infected Opioid Users in an Integrated Care Effectiveness Study (CHOICES) Scale-Up
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
California
-
Tarzana, California, United States, 91356
- Tarzana Treatment Centers
-
-
Florida
-
Miami, Florida, United States, 33136
- Jackson Memorial Hospital
-
-
Illinois
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Chicago, Illinois, United States, 60612
- Ruth M. Rothstein CORE Center
-
-
Kentucky
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Lexington, Kentucky, United States, 40536
- University of Kentucky Bluegrass Care Clinic
-
-
Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins University, Bartlett Specialty Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participant is at least 18 years old
- Participant has provided written informed consent and HIPAA for medical record abstraction
- Participant meets Diagnostic and Statistical (DSM)-5 criteria for moderate or severe opioid use disorder
- Willing to be randomized to antagonist-based therapy or TAU for treatment of opioid use disorder
- Has an HIV viral RNA count of greater than 200 copies/ml (not clinically suppressed)
- Willing to establish ongoing HIV care at the site if not already receiving ongoing care
- If female, willing to take at least one evidence-based measure to avoid becoming pregnant
Exclusion Criteria:
- Participant has a serious medical, psychiatric, or substance use disorder that, in the opinion of the study physician, would make participation hazardous to the participant, compromise study findings, or prevent participant from completing the study. Examples include:
- Acutely life-threatening medical illnesses (e.g., active opportunistic infection, uncompensated heart failure, end-stage liver disease, acute hepatitis and moderate to severe renal impairment) as assessed by medical history, review of symptoms, physical exam and/or laboratory assessments
- Severe, inadequately treated mental health disorder (e.g., active psychosis, uncontrolled manic-depressive illness) as assessed by history and/or clinical interview
- Suicidal or homicidal ideation requiring immediate attention
- Participant has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) liver enzymes greater than five times the upper limit of normal on screening phlebotomy
- Participant has an international normalized ratio (INR) > 1.5 or platelet count <100k
- Participant has a known allergy or sensitivity to naloxone, naltrexone, polyactide-co-glycolide, carboxymethylcellulose, or other components of the Vivitrol diluent
- Anticipate undergoing surgery during study participation
- Have chronic pain requiring ongoing pain management with opioid analgesics
- If female, currently (at time of consent) pregnant or breastfeeding or planning on conceiving in the coming months
- Body habitus that, in the judgment of the study physician, precludes safe intramuscular injection on XR-NTX (e.g., excess fat tissue over the buttocks)
- Received methadone of buprenorphine maintenance therapy for treatment of opioid dependence in the 4 weeks prior to screening
- Have taken an investigational drug in another study within 30 days of study consent
- Have had treatment with XR-NTX for opioid or alcohol dependence in the 4 weeks prior to consent
- Are currently in jail, prison or have a pending legal action which may prevent an individual from completing the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: XR-NTX
Extended-release naltrexone
|
Six monthly injections of extended-release naltrexone
|
Active Comparator: TAU
Treatment as usual
|
Standard treatment for opioid use disorder provided at each HIV clinic
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With HIV Viral Suppression, Missing Imputed as Unsuppressed
Time Frame: 12 weeks and 24 weeks
|
HIV-1 RNA <200 copies/ml
|
12 weeks and 24 weeks
|
Number of Participants With HIV Viral Suppression, Complete Case
Time Frame: 12 weeks and 24 weeks
|
HIV-1 RNA <200 copies/ml
|
12 weeks and 24 weeks
|
Number of Participants With HIV Viral Suppression, Per-protocol
Time Frame: 12 weeks and 24 weeks
|
HIV-1 RNA <200 copies/ml
|
12 weeks and 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Veterans Aging Cohort Study (VACS) Index
Time Frame: Baseline and 24 weeks
|
Absolute value of participant VACS Index at baseline and 24 weeks Veterans Aging Cohort Study Index Minimum value: 0 Maximum value: 164 A higher score means a worse outcome. |
Baseline and 24 weeks
|
CD4 Count
Time Frame: Baseline and 24 weeks
|
Cluster of Differentiation 4 Absolute value of CD4 count at baseline and 24 weeks. |
Baseline and 24 weeks
|
Engagement in HIV Care: Antiretroviral Therapy Prescribed
Time Frame: Baseline and 24 weeks
|
Absolute value of participants prescribed ART at baseline and within 24 weeks following randomization.
Each individual can be scored 0 (not prescribed ART) or 1 (prescribed ART) at both baseline and follow-up, after which his or her outcome score will be the follow-up score minus the baseline score.
Outcomes will be analyzed via rank-based methods such as Wilcoxon rank-sum tests.
|
Baseline and 24 weeks
|
Engagement in HIV Care: 100% Antiretroviral Therapy Adherence
Time Frame: 24 weeks
|
Number of participants taking 100% of prescribed ART doses in the past month at 24 weeks for those prescribed ART at any point during the 24 week trial (proportion; self-reported medication adherence measure).
Chi-squared test comparing proportion to treatment assignment, for those prescribed ART.
|
24 weeks
|
Number of Participants With at Least 1 HIV Care Visit in Past 12 Weeks
Time Frame: 24 weeks
|
At least 1 HIV care visit in past 12 weeks
|
24 weeks
|
Number of Participants Who Had Unprotected Sex in Past 30 Days
Time Frame: Baseline and 24 weeks
|
Past 30 day unprotected sex, as measured by the Risk Assessment Battery at baseline and week 24 (binary; self-report).
|
Baseline and 24 weeks
|
Number of Participants With Multiple Sex Partners in Past 30 Days
Time Frame: Baseline and 24 weeks
|
Past 30 day multiple sex partners, as measured by the Risk Assessment Battery at baseline and week 24 (binary; self-report).
|
Baseline and 24 weeks
|
Engagement in HIV Care: Quality of Life
Time Frame: Baseline and 24 weeks
|
Past 30 day health-related quality of life as measured by the EQ-5D questionnaire at baseline and week 24. Minimum value: 0 Maximum value: 100 Higher scores mean a better outcome |
Baseline and 24 weeks
|
Average Number of Self-Reported Days of Opioid Use in Last 30 Days
Time Frame: Between baseline and 24 weeks
|
Average number of days of opioid use between baseline and 24 weeks, measured by the Timeline Follow-Back (count; self-report), will be used to compare opioid use by treatment group.
Confirmatory analysis will assess opioid use by the average number of days of opioid use in the last 30 days of the study (by Addiction Severity Index-lite; count; self-report) and the number of monthly urine drug screen (UDS) negative for opioids between baseline and 24 weeks (count; laboratory data).
|
Between baseline and 24 weeks
|
Number of Participants Who Test Positive for Opioids at 24 Weeks
Time Frame: 24 weeks
|
Number and percent of participants with UDS positive for opioids at 24 weeks.
|
24 weeks
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Clinical Trials Network-0067
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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