Comparing Treatments for HIV-Infected Opioid Users in an Integrated Care Effectiveness Study (CHOICES) Scale-Up
Primary Purpose
Opioid-use Disorder, Hiv
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Naltrexone Injectable Suspension
Treatment as usual
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-use Disorder
Eligibility Criteria
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
Sites / Locations
- Tarzana Treatment Centers
- Jackson Memorial Hospital
- Ruth M. Rothstein CORE Center
- University of Kentucky Bluegrass Care Clinic
- Johns Hopkins University, Bartlett Specialty Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
XR-NTX
TAU
Arm Description
Extended-release naltrexone
Treatment as usual
Outcomes
Primary Outcome Measures
Number of Participants With HIV Viral Suppression, Missing Imputed as Unsuppressed
HIV-1 RNA <200 copies/ml
Number of Participants With HIV Viral Suppression, Complete Case
HIV-1 RNA <200 copies/ml
Number of Participants With HIV Viral Suppression, Per-protocol
HIV-1 RNA <200 copies/ml
Secondary Outcome Measures
Veterans Aging Cohort Study (VACS) Index
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.
CD4 Count
Cluster of Differentiation 4
Absolute value of CD4 count at baseline and 24 weeks.
Engagement in HIV Care: Antiretroviral Therapy Prescribed
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.
Engagement in HIV Care: 100% Antiretroviral Therapy Adherence
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.
Number of Participants With at Least 1 HIV Care Visit in Past 12 Weeks
At least 1 HIV care visit in past 12 weeks
Number of Participants Who Had Unprotected Sex in Past 30 Days
Past 30 day unprotected sex, as measured by the Risk Assessment Battery at baseline and week 24 (binary; self-report).
Number of Participants With Multiple Sex Partners in Past 30 Days
Past 30 day multiple sex partners, as measured by the Risk Assessment Battery at baseline and week 24 (binary; self-report).
Engagement in HIV Care: Quality of Life
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
Average Number of Self-Reported Days of Opioid Use in Last 30 Days
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).
Number of Participants Who Test Positive for Opioids at 24 Weeks
Number and percent of participants with UDS positive for opioids at 24 weeks.
Full Information
NCT ID
NCT03275350
First Posted
August 28, 2017
Last Updated
April 26, 2022
Sponsor
Oregon Health and Science University
Collaborators
National Institute on Drug Abuse (NIDA), Johns Hopkins University, University of Kentucky, Jackson Health System, Tarzana Treatment Centers, Ruth M. Rothstein CORE Center
1. Study Identification
Unique Protocol Identification Number
NCT03275350
Brief Title
Comparing Treatments for HIV-Infected Opioid Users in an Integrated Care Effectiveness Study (CHOICES) Scale-Up
Official Title
Comparing Treatments for HIV-Infected Opioid Users in an Integrated Care Effectiveness Study (CHOICES) Scale-Up
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 5, 2018 (Actual)
Primary Completion Date
November 8, 2019 (Actual)
Study Completion Date
November 8, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
National Institute on Drug Abuse (NIDA), Johns Hopkins University, University of Kentucky, Jackson Health System, Tarzana Treatment Centers, Ruth M. Rothstein CORE Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The Primary Objective of this study is to compare the effectiveness of HIV clinic-based extended-release Naltrexone (XR-NTX) in decreasing substance use and increasing HIV viral suppression in HIV-infected participants with opioid use disorder to Treatment as Usual in this population.
Detailed Description
The CTN-0055 CHOICES pilot study demonstrated the feasibility of extended-release naltrexone (XR-NTX) for treatment of opioid use disorder in HIV primary care. The CTN-0067 CHOICES scale-up study builds on lessons learned from the pilot and uses the Consolidated Framework for Implementation Research to advance understanding of XR-NTX adoption in HIV primary care clinics. The study is an open-label, randomized, comparative effectiveness trial of office-based XR-NTX for 24 weeks (6 monthly injections) versus treatment as usual (TAU) in HIV-infected participants with untreated opioid use disorder. Each participant will be engaged in the overall study for 25 to 28 weeks, depending on the speed of screening and enrollment procedures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder, Hiv
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Actual)
8. Arms, Groups, and Interventions
Arm Title
XR-NTX
Arm Type
Active Comparator
Arm Description
Extended-release naltrexone
Arm Title
TAU
Arm Type
Active Comparator
Arm Description
Treatment as usual
Intervention Type
Drug
Intervention Name(s)
Naltrexone Injectable Suspension
Intervention Description
Six monthly injections of extended-release naltrexone
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Intervention Description
Standard treatment for opioid use disorder provided at each HIV clinic
Primary Outcome Measure Information:
Title
Number of Participants With HIV Viral Suppression, Missing Imputed as Unsuppressed
Description
HIV-1 RNA <200 copies/ml
Time Frame
12 weeks and 24 weeks
Title
Number of Participants With HIV Viral Suppression, Complete Case
Description
HIV-1 RNA <200 copies/ml
Time Frame
12 weeks and 24 weeks
Title
Number of Participants With HIV Viral Suppression, Per-protocol
Description
HIV-1 RNA <200 copies/ml
Time Frame
12 weeks and 24 weeks
Secondary Outcome Measure Information:
Title
Veterans Aging Cohort Study (VACS) Index
Description
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.
Time Frame
Baseline and 24 weeks
Title
CD4 Count
Description
Cluster of Differentiation 4
Absolute value of CD4 count at baseline and 24 weeks.
Time Frame
Baseline and 24 weeks
Title
Engagement in HIV Care: Antiretroviral Therapy Prescribed
Description
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.
Time Frame
Baseline and 24 weeks
Title
Engagement in HIV Care: 100% Antiretroviral Therapy Adherence
Description
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.
Time Frame
24 weeks
Title
Number of Participants With at Least 1 HIV Care Visit in Past 12 Weeks
Description
At least 1 HIV care visit in past 12 weeks
Time Frame
24 weeks
Title
Number of Participants Who Had Unprotected Sex in Past 30 Days
Description
Past 30 day unprotected sex, as measured by the Risk Assessment Battery at baseline and week 24 (binary; self-report).
Time Frame
Baseline and 24 weeks
Title
Number of Participants With Multiple Sex Partners in Past 30 Days
Description
Past 30 day multiple sex partners, as measured by the Risk Assessment Battery at baseline and week 24 (binary; self-report).
Time Frame
Baseline and 24 weeks
Title
Engagement in HIV Care: Quality of Life
Description
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
Time Frame
Baseline and 24 weeks
Title
Average Number of Self-Reported Days of Opioid Use in Last 30 Days
Description
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).
Time Frame
Between baseline and 24 weeks
Title
Number of Participants Who Test Positive for Opioids at 24 Weeks
Description
Number and percent of participants with UDS positive for opioids at 24 weeks.
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Tarzana Treatment Centers
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Facility Name
Jackson Memorial Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Ruth M. Rothstein CORE Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Kentucky Bluegrass Care Clinic
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Johns Hopkins University, Bartlett Specialty Clinic
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34758887
Citation
Hoffman KA, Baker R, Fanucchi LC, Lum PJ, Kunkel LE, Ponce Terashima J, McCarty D, Jacobs P, Korthuis PT. Perspectives on extended-release naltrexone induction among patients living with HIV and opioid use disorder: a qualitative analysis. Addict Sci Clin Pract. 2021 Nov 10;16(1):67. doi: 10.1186/s13722-021-00277-z.
Results Reference
derived
Learn more about this trial
Comparing Treatments for HIV-Infected Opioid Users in an Integrated Care Effectiveness Study (CHOICES) Scale-Up
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