Adherence to HIV Therapy in Heroin Addicts: Oral vs. Extended Release Naltrexone

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University of Pennsylvania
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT02046252
First received: October 29, 2013
Last updated: January 23, 2014
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
HIV+
Drug: Oral naltrexone
Drug: Naltrexone implant
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adherence to HIV Therapy in Heroin Addicts: Oral vs. Extended Release Naltrexone

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Viral Load [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adherence to ART [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: June 2010
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Naltrexone Implant + ART
Naltrexone implant maintenance 48 weeks plus psychotherapy N=100
Drug: Naltrexone implant
monthly
Active Comparator: ON Oral Naltrexone
ON (oral) naltrexone maintenance 48 weeks plus psychotherapy N=100
Drug: Oral naltrexone
50 mg/day

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT02046252

Locations
Russian Federation
Botkin Infectious Disease Hospital Recruiting
Leningrad, Russian Federation
Contact: Evgeny Krupitsky, M.D., Ph.D.    78122969906    kruenator@gmail.com   
Contact    78122969906    kruenator@gmail.com   
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: George E Woody, MD University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02046252     History of Changes
Other Study ID Numbers: R01-DA-0263360-01, 5R01DA026336
Study First Received: October 29, 2013
Last Updated: January 23, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014