Comparing Treatments for HIV-Infected Opioid and Alcohol Users in an Integrated Care Effectiveness Study
Condition: Opioid Use Disorder; Alcohol Use Disorder
MeSH terms: Alcoholism; Opioid-Related Disorders
Intervention: Extended Release Naltrexone; Treatment As usual
Intervention MeSH terms: Naltrexone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Substance related disorders; HIV; naltrexone

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Meet Diagnostic and Statistical Manual (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 treatment as usual (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 community treatment program(CTP) if not
             already receiving ongoing care.

          5. Be willing to initiate antiretroviral therapy (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 international normalized ratio (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.