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

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.

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