Adherence to HIV Therapy in Heroin Addicts: Oral vs XR-NTX

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Substance use, particularly the compulsive behaviors associated with addiction, lead to unhealthy behaviors including non-adherence to antiretroviral therapy (ART) and treatment failure. High on the list of disorders leading to non-adherence is heroin addiction as a wide range of impulsive, high-risk behaviors accompanies it. The science of adherence would be improved by developing new methods to prevent relapse to heroin addiction, especially methods that can be used in settings that are not limited by the aims to test such a method using an implantable naltrexone formulation (IN) that is approved in Russia and blocks opioid effects for 3 months. The efficacy of the IN should be better than oral naltrexone (ON) because it does not depend on daily behavior to take a tablet and maintains a constant plasma level for months, which should result in sustained blockade, less relapse, and better ART adherence and treatment response.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Heroin; Naltrexone

Criteria

Inclusion Criteria:

• must be HIV+ men/women starting their first episode of ART or starting a new ART treatment episode and was prescribed medications that suppressed the virus to <400 copies during their last treatment

• understand that they will be prescribed ART medications that they have never received and to which their virus is likely to be susceptible

• viral loads of 1,000 copies or more

• meet the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) criteria for opioid dependence in early remission

• have a negative opiate urine toxicology and alcohol breath test

• show no evidence of physiologic dependence on physical exam and following a naltrexone challenge

• have a stable address in the St. Petersburg or Leningrad Region of Russia area

• have a valid telephone number where subject can be reached

• have a negative pregnancy test and use adequate contraception

• have the ability to give informed consent as judged by ability to read the consent and correctly answer 9 of 10 questions about the study on a quiz that will be administered after discussing the study and reading the consent

Exclusion Criteria:

• not be currently psychotic as determined by a psychiatric examination (i.e.; schizophrenia, paranoid disorder, mania)

• not have current suicidal or homicidal ideation requiring immediate attention as determined at baseline assessment

• not have an uncontrolled seizure disorder

• not have cognitive impairment with an inability to read and understand the consent

• not have significant laboratory abnormality such as >2 grade anemia

• not have hepatic transaminase levels >5 times the upper limit of normal

• not have serum creatinine >1.5 times the upper limit of normal

• not have pending legal charges with impending incarceration

• not be concurrently participating in another treatment study

• not currently taking naltrexone