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

NCT01882361 | Completed Phase 2 DMC

• 2 other identifiers: 816019R01DA033670
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Opiate Dependence; Human Immunodeficiency Virus

Keywords

opioid addiction; opioid treatment; naloxone

Outcome Measures

Primary Outcomes (1)

• Opiate positive urine tests

  Reduction in drug use as seen by the primary urine outcomes will significantly favor the 48-week Vivitrol condition

  12 months

Secondary Outcomes (1)

• HIV sex risk

  12 months

Other Outcomes (1)

• adverse events

  12 months

Study Arms (2)

injectable naltrexone

ACTIVE COMPARATOR

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

Drug: injectable naltrexone

placebo injection for naltrexone

PLACEBO COMPARATOR

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

Drug: placebo comparator

Interventions

injectable naltrexone 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.

Also known as: Vivitrol

injectable naltrexone

placebo comparator DRUG

this placebo has no specific pharmacological activity

placebo injection for naltrexone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Federal Medical Research Center for Psychiatry and Narcology (FMRC)

Moscow, 119002, Russia

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Acquired Immunodeficiency Syndrome

Interventions

vivitrol

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• George E Woody, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Tatiana Klimenko, MD, PhD

  Federal Medical Research Center for Psychiatry and Narcology (FMRC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2013
• First Posted: June 20, 2013
• Study Start: June 1, 2013
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: November 6, 2020

Record last verified: 2020-11

Locations

RU (1)