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Comparing Treatments for HIV-Infected Opioid Users in an Integrated Care Effectiveness Study (CHOICES) Scale-Up

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ClinicalTrials.gov Identifier: NCT03275350
Recruitment Status : Recruiting
First Posted : September 7, 2017
Last Update Posted : July 31, 2018
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Johns Hopkins University
University of Kentucky
Whitman-Walker Health
Jackson Health System
Florida Department of Health
Tarzana Treatment Centers
Ruth M. Rothstein CORE Center
Information provided by (Responsible Party):
P. Todd Korthuis, Oregon Health and Science University

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.

Condition or disease Intervention/treatment Phase
Opioid-use Disorder Hiv Drug: Naltrexone Injectable Suspension Other: Treatment as usual Phase 2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparing Treatments for HIV-Infected Opioid Users in an Integrated Care Effectiveness Study (CHOICES) Scale-Up
Actual Study Start Date : February 5, 2018
Estimated Primary Completion Date : March 6, 2020
Estimated Study Completion Date : March 6, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: XR-NTX
Extended-release naltrexone
Drug: Naltrexone Injectable Suspension
Six monthly injections of extended-release naltrexone

Active Comparator: TAU
Treatment as usual
Other: Treatment as usual
Standard treatment for opioid use disorder provided at each HIV clinic




Primary Outcome Measures :
  1. HIV Viral Suppression [ Time Frame: 24 weeks ]
    HIV-1 RNA <200 copies/ml


Secondary Outcome Measures :
  1. Veterans Aging Cohort Study (VACS) Index [ Time Frame: 24 weeks ]
    Change in VACS Index compared with screening

  2. Cluster of Differentiation 4 (CD4) [ Time Frame: 24 weeks ]
    Change in CD4 count compared with screening

  3. Engagement in HIV Care: Antiretroviral Therapy Prescribed [ Time Frame: 24 weeks ]
    Change in the proportion of study participants prescribed ART within 24 weeks following randomization, compared to baseline. 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.

  4. Engagement in HIV Care: Antiretroviral Therapy Adherence [ Time Frame: 24 weeks ]
    Proportion 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.

  5. Engagement in HIV Care: Retention in HIV Care [ Time Frame: 24 weeks ]
    Number of HIV primary care visits at 24 weeks (count, chart abstraction). Outcome scores will be analyzed via rank-based methods such as Wilcoxon rank-sum tests.

  6. Engagement in HIV Care: HIV Risk Behaviors [ Time Frame: Week 24 ]
    Past 30 day injection drug use, unprotected sex, multiple sexual partners as measured by the Risk Assessment Battery at week 24 (binary; self-report). Chi-squared test comparing proportion to treatment assignment.

  7. Engagement in HIV Care: Quality of Life [ Time Frame: 24 weeks ]
    Past 30 day health-related quality of life as measured by the EQ-5D questionnaire at week 24. Change from baseline in mean EQ-5D score assessed by treatment group using paired t-test, or analysis of change via ordinary least squares.

  8. Antiretroviral Therapy Adherence Mediation Variables: Days of Opioid Use [ Time Frame: Between baseline and 24 weeks ]
    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 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). Analyzed using rank-based methods such as Wilcoxon rank-sum tests.

  9. Antiretroviral Therapy Adherence Mediation Variables: Opioid Abstinence [ Time Frame: Weeks 20-24 ]
    Past 30 day opioid abstinence (by Addiction Severity Index (ASI)-life self-report, Timeline Follow-Back and UDS confirmation) in the final 30 days of the 24 week trial (binary; self-report + UDS). Analyzed via rank-based methods such as Wilcoxon rank-sum tests.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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, carboxymethycellulose, 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

Information from the National Library of Medicine

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): NCT03275350


Contacts
Contact: Todd Korthuis, MD 503-494-8044 korthuis@ohsu.edu
Contact: Dennis McCarty, PhD 503-494-1177 mccartyd@ohsu.edu

Locations
United States, California
Tarzana Treatment Centers Recruiting
Tarzana, California, United States, 91356
Contact: Ken Bachrach, MD    818-996-1051 ext 3806    kbachrach@tarzanatc.org   
Contact: Shaun Flax, MA    (818( 996-1051 ext 1105    sflax@tarzanatc.org   
United States, District of Columbia
Whitman-Walker Health Recruiting
Washington, District of Columbia, United States, 20036
Contact: Andrea Duncan    202-745-6152    aduncan@whitman-walker.org   
Principal Investigator: Sarah Henn, MD, MPH         
United States, Florida
Jackson Memorial Hospital Recruiting
Miami, Florida, United States, 33136
Contact: Jessica Ucha, MSEd    305-243-4399    jucha@med.miami.edu   
Principal Investigator: Allen Rodriguez, MD         
Florida Department of Health - Sunshine Care Clinic Recruiting
Orlando, Florida, United States, 32805
Contact: Argentina Clarke, MS    407-868-4687    Argentina.Clarke@flhealth.gov   
Contact: Ana Rua-Dobles    407-723-4014      
Principal Investigator: Lynne Hopkins, MD         
United States, Illinois
Ruth M. Rothstein CORE Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Erin Jaworski, MPH    312-572-4573    ejaworski@cookcountyhhs.org   
Principal Investigator: Pamela Vergara-Rodriguez, MD         
United States, Kentucky
University of Kentucky Bluegrass Care Clinic Recruiting
Lexington, Kentucky, United States, 40536
Contact: Xian Brooks, MPH    859-323-7333    xian.brooks@uky.edu   
Contact: Diana Ball, CSW    859-323-8178      
Principal Investigator: Laura Fanucchi, MD         
United States, Maryland
Johns Hopkins University, Bartlett Specialty Clinic Recruiting
Baltimore, Maryland, United States, 21287
Contact: Mary Ann Stephens, PhD       mchutua1@jhmi.edu   
Principal Investigator: Gregory Lucas, MD, PhD         
Sponsors and Collaborators
Oregon Health and Science University
National Institute on Drug Abuse (NIDA)
Johns Hopkins University
University of Kentucky
Whitman-Walker Health
Jackson Health System
Florida Department of Health
Tarzana Treatment Centers
Ruth M. Rothstein CORE Center

Responsible Party: P. Todd Korthuis, Associate Professor of Medicine, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03275350     History of Changes
Other Study ID Numbers: Clinical Trials Network-0067
First Posted: September 7, 2017    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Analgesics, Opioid
Naltrexone
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists