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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Oregon Health and Science University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
P. Todd Korthuis, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01908062
First received: July 23, 2013
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to learn how best to treat substance use disorders in an HIV clinic setting. Specifically, the purpose is to learn if extended-release naltrexone (XR-NTX) would be an effective and acceptable treatment for HIV-infected individuals with opioid or alcohol use disorders.


Condition Intervention Phase
Opioid Use Disorder
Alcohol Use Disorder
Drug: Extended Release Naltrexone
Other: Treatment As usual
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparing Treatments for HIV-Infected Opioid and Alcohol Users in an Integrated Care Effectiveness Study

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Treatment initiation [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Successful induction onto XR-NTX or initiation of treatment as usual within 4 weeks of randomization.

  • Retention on treatment [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Percent of expected doses of XR-NTX received or percent of recommended treatment received for TAU arm.


Secondary Outcome Measures:
  • HIV Outcomes [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: Yes ]
    • 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.


Estimated Enrollment: 50
Study Start Date: June 2014
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Meet DSM-5 criteria for moderate or severe opioid use disorder and/or alcohol use disorder.
  2. Be willing to be randomized to antagonist-based therapy or TAU for treatment of opioid and/or alcohol use disorders.
  3. Be HIV-infected as defined by history of positive HIV serology or HIV RNA pcr >10,000 copies/mL).
  4. Be willing to establish ongoing HIV care at CTP if not already receiving ongoing care.
  5. Be willing to initiate ART if not already prescribed ART, regardless of CD4 count.
  6. Be at least 18 years old.
  7. Be able to provide written informed consent and HIPAA (if applicable) for medical record abstraction.
  8. Be able to communicate in English.
  9. If female, be willing to take measures to avoid becoming pregnant.

Exclusion Criteria:

Individuals will be excluded from pilot study participation if they:

  • Have a serious medical, psychiatric or substance use disorder that, in the opinion of the study physician, would make study participation hazardous to the participant, compromise study findings, or prevent the participant from completing the study.

Examples include:

  1. Disabling or terminal medical illness (e.g., active opportunistic infection, uncompensated heart failure, cirrhosis or end-stage liver disease, acute hepatitis and moderate to severe renal impairment) as assessed by medical history, review of systems, physical exam and/or laboratory assessments;

    1. Severe, untreated or inadequately treated mental health disorder (e.g., active psychosis, uncontrolled manic-depressive illness) as assessed by history and/or clinical interview;
    2. Current severe benzodiazepine or other depressant or sedative hypnotic use requiring medical detoxification;
    3. Suicidal or homicidal ideation requiring immediate attention.
  2. Have aspartate aminotransferase (AST) or alanine aminotransferase (ALT) liver enzymes greater than 5 times upper limit of normal on screening phlebotomy. Results from tests conducted within the past 30 days which are abstracted from medical record information are acceptable.
  3. Have INR > 1.5 or platelet count <100k. Results from tests conducted within the past 30 days which are abstracted from medical record information are acceptable.
  4. Have known allergy or sensitivity to naloxone, naltrexone, polylactide-co-glycolide, carboxymethylcellulose, or other components of the Vivitrol® diluents.
  5. Anticipate undergoing surgery during study participation.
  6. Have chronic pain requiring ongoing pain management with opioid analgesics.
  7. Pending legal action or other reasons that might prevent an individual from completing the study.
  8. Currently pregnant or breastfeeding.
  9. Body habitus that, in the judgment of the study physician, precludes safe intramuscular injection of XR-NTX, (e.g. excess fat tissue over the buttocks).
  10. Received methadone or buprenorphine maintenance therapy for treatment of opioid dependence in the 4 weeks prior to screening.
  11. Have taken an investigational drug in another study within 30 days of study consent.
  12. Have ECG findings that, in the opinion of the study medical clinician would preclude safe participation in the study. Results from ECGs conducted within the past 30 days which are abstracted from medical record information are acceptable.
  13. Have had treatment with XR-NTX for opioid or alcohol dependence in the 3 months prior to screening.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01908062

Contacts
Contact: Philip T Korthuis, MD, MPH 503-494-8044 korthuis@ohsu.edu
Contact: Lynn Kunkel, MS 503-494-2562 kunkell@ohsu.edu

Locations
United States, Illinois
The CORE Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Pamela Vergara-Rodriguez    312-572-4753      
Contact: Melody Bather-Gardner    312-572-4518      
Principal Investigator: Pamela Vergara-Rodriguez         
Canada, British Columbia
University of British Columbia Recruiting
Vancouver, British Columbia, Canada
Contact: Evan Wood, MD, PhD    604-682-2344 ext 66373      
Contact: Cheyenne Johnson    604-682-2344 ext 62202      
Principal Investigator: Evan Wood, MD, PhD         
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Philip T Korthuis, MD, MPH Oregon Health and Science University
  More Information

No publications provided

Responsible Party: P. Todd Korthuis, Associate Professor of Medicine, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01908062     History of Changes
Other Study ID Numbers: NIDA-CTN-0055, U10DA015815
Study First Received: July 23, 2013
Last Updated: June 19, 2014
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Keywords provided by Oregon Health and Science University:
Substance related disorders
HIV
naltrexone

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior
Naltrexone
Analgesics, Opioid
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics
Central Nervous System Depressants

ClinicalTrials.gov processed this record on July 29, 2014