Opioid Relapse & HIV Risk: 48 Versus 24 Weeks of Injectable Extended Release Naltrexone
Information source: University of Pennsylvania
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Opiate Dependence; Human Immunodeficiency Virus
Intervention: injectable naltrexone (Drug); placebo comparator (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: University of Pennsylvania Official(s) and/or principal investigator(s): George E Woody, MD, Principal Investigator, Affiliation: University of Pennsylvania Evgenia A Koshkina, MD, PhD, Principal Investigator, Affiliation: National Research Center on Addictions, RU
Overall contact: George E Woody, MD, Phone: 215-399-0980, Ext: 112, Email: woody@tresearch.org
Summary
To address the question of the comparison of two courses of Vivitrol with differing lengths
in 130 HIV negative, consenting, opioid addicted patients who have completed inpatient
treatment. Participants will be randomized under double blind conditions to a 24 or 48-week
course of pharmacotherapy, along with bi-weekly drug counselling, over 48 weeks, with
follow-ups at weeks 60 and 72. The 24-week cohort will receive Vivitrol placebo injections
in weeks 24 to 48.
Clinical Details
Official title: Opioid Relapse & HIV Risk: 48 Versus 24 Weeks of Injectable Extended Release Naltrexone
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Opiate positive urine tests
Secondary outcome: HIV sex risk
Detailed description:
1. 2.1 Primary and Secondary Outcome Measures
Primary outcomes are:
1) Opiate positive urine tests; 2) HIV injecting risk.
Secondary outcomes are:
1) Time to relapse; 2) HIV sex risk; 3) Proportion of appointments kept; 6) Psychiatric
symptoms; 7) Opioid craving; 8) Self-reported drug use; 9) Money spent for drugs; 10)
Employment; 11) Arrests; 12) Overall adjustment; 12) Adverse events.
Hypotheses are that:
1. Primary outcomes will significantly favor the 48-week Vivitrol condition;
2. Five or more secondary outcomes will favor the 48-week condition; none will favor the
24-week condition.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- HIV-negative men and women 18 years of age or older who meet the Diagnostic and
Statistical Manual of Mental Disorders 4th edition-Text Revision (DSM- IV-TR)
criteria for opioid dependence
- Must be voluntarily seeking treatment for opioid dependence, with injection heroin as
the drug and administration route of choice
- Must report sharing injection equipment during the past year
- Must have successfully completed inpatient detoxification at the The National Center
on Addictions in Moscow (NRCA)
- Must have no current evidence of physiologic dependence
- Must have a stable address in Moscow with a telephone number where they can be
reached
- If female, must have a negative pregnancy test and use of medically acceptable
contraception if of childbearing age
- Must be able to provide informed consent as judged by the ability to read the consent
and correctly answer 9 out of 10 questions about the study on a quiz
Exclusion Criteria:
- No current condition of psychosis (schizophrenia,paranoid disorder, mania)
- No history of major psychiatric disorders such as Schizophrenia, Major Depression
with suicidal attempts, Bipolar I, uncontrolled epilepsy or other seizure disorder
- No current dependence (within the past year) to drugs other than prescription opiates
or heroin, caffeine, marijuana, or nicotine based on the Diagnostic and Statistical
Manual of Mental Disorders-Text Revision (DSM - IV-TR) criteria
- No current alcohol dependence or alcohol use disorder that would preclude successful
completion of study procedures
- No current suicidal or homicidal ideation requiring immediate attention as determined
at baseline assessment
- No cognitive impairment with inability to read and understand the consent
- No significant laboratory abnormality such as haemoglobin <10, hepatic transaminase
levels >3 times upper limit of normal or serum creatinine that is >1. 5 times upper
limit of normal
- No legal charges with impending incarceration
- No concurrent participation in another treatment study
- Cannot be scheduled for surgery or be likely to require opioids for pain control in
next 2 years
- Not currently taking naltrexone or currently receiving other treatment
(pharmacological or behavioral) for drug dependence or currently receiving
psychoactive medication
- Cannot have had receipt of any approved or investigational depot product administered
into the gluteal muscle within 6 months before screening
- Cannot be on any excluded medication at screening or be anticipating the use of an
excluded medication during the study period
- Cannot have participated in a clinical trial of a pharmacological agent within 30
days prior to screening
Locations and Contacts
George E Woody, MD, Phone: 215-399-0980, Ext: 112, Email: woody@tresearch.org
National Research Center on Addictions, Moscow 119002, Russian Federation; Recruiting Mariya A Vinnikova, MD, PhD, Phone: 8-985-233-47-53, Email: marya.v@mail.ru Mariya A Vinnikova, MD, PhD, Principal Investigator
Additional Information
Starting date: June 2013
Last updated: January 14, 2015
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