Opioid Relapse & HIV Risk: 48 Versus 24 Weeks of Injectable Extended Release Naltrexone

NCT ID: NCT01882361

Last Updated: 2020-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2020-07-31

Brief 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.

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.

Conditions

Opiate Dependence; Human Immunodeficiency Virus

Keywords

opioid addiction; opioid treatment; naloxone

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

injectable naltrexone

One dose of injectable extended release naltrexone (Vivitrol), 380mg dosage, given every four weeks in a 48-week trial.

Group Type: ACTIVE_COMPARATOR

injectable naltrexone

Intervention Type: DRUG

Vivitrol is an extended-release, microsphere formulation of naltrexone designed to be administered by intramuscular (IM) gluteal injection every 4 weeks or once a month. After IM injection, the naltrexone plasma concentration time profile is characterized by a transient initial peak, which occurs approximately 2 hours after injection, followed by a second peak observed approximately 2 - 3 days later. Beginning approximately 14 days after dosing, concentrations slowly decline, with measurable levels for greater than 1 month.

placebo injection for naltrexone

placebo comparator injection starting at week 24 in a 48-week trial.

Group Type: PLACEBO_COMPARATOR

placebo comparator

Intervention Type: DRUG

this placebo has no specific pharmacological activity

Interventions

injectable naltrexone

Vivitrol is an extended-release, microsphere formulation of naltrexone designed to be administered by intramuscular (IM) gluteal injection every 4 weeks or once a month. After IM injection, the naltrexone plasma concentration time profile is characterized by a transient initial peak, which occurs approximately 2 hours after injection, followed by a second peak observed approximately 2 - 3 days later. Beginning approximately 14 days after dosing, concentrations slowly decline, with measurable levels for greater than 1 month.

Intervention Type: DRUG

placebo comparator

this placebo has no specific pharmacological activity

Intervention Type: DRUG

Other Intervention Names

Vivitrol

Eligibility 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 Federal Medical Research Center for Psychiatry and Narcology (FMRCPN)
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

George E Woody, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Tatiana Klimenko, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal Medical Research Center for Psychiatry and Narcology (FMRC)

Locations

Federal Medical Research Center for Psychiatry and Narcology (FMRC)

Moscow, , Russia

Countries

Russia

Other Identifiers

R01DA033670

Identifier Type: NIH

Identifier Source: secondary_id

View Link

816019

Identifier Type: -

Identifier Source: org_study_id