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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

Page last updated: August 23, 2015

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