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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01882361
Recruitment Status : Active, not recruiting
First Posted : June 20, 2013
Last Update Posted : January 9, 2020
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Opiate Dependence Human Immunodeficiency Virus Drug: injectable naltrexone Drug: placebo comparator Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Opioid Relapse & HIV Risk: 48 Versus 24 Weeks of Injectable Extended Release Naltrexone
Actual Study Start Date : June 2013
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: injectable naltrexone
One dose of injectable extended release naltrexone (Vivitrol), 380mg dosage, given every four weeks in a 48-week trial.
Drug: 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.
Other Name: Vivitrol

Placebo Comparator: placebo injection for naltrexone
placebo comparator injection starting at week 24 in a 48-week trial.
Drug: placebo comparator
this placebo has no specific pharmacological activity

Primary Outcome Measures :
  1. Opiate positive urine tests [ Time Frame: 12 months ]
    Reduction in drug use as seen by the primary urine outcomes will significantly favor the 48-week Vivitrol condition

Secondary Outcome Measures :
  1. HIV sex risk [ Time Frame: 12 months ]
    Participants will show significant HIV sex risk behaviors in the 48-week vivitrol condition.

Other Outcome Measures:
  1. adverse events [ Time Frame: 12 months ]
    No increase in known adverse events for the vivitrol arm as seen in other studies.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01882361

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Russian Federation
Federal Medical Research Center for Psychiatry and Narcology (FMRC)
Moscow, Russian Federation, 119002
Sponsors and Collaborators
University of Pennsylvania
National Institute on Drug Abuse (NIDA)
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Principal Investigator: George E Woody, MD University of Pennsylvania
Principal Investigator: Tatiana Klimenko, MD, PhD Federal Medical Research Center for Psychiatry and Narcology (FMRC)
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Responsible Party: University of Pennsylvania Identifier: NCT01882361    
Other Study ID Numbers: 816019
R01DA033670 ( U.S. NIH Grant/Contract )
First Posted: June 20, 2013    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Keywords provided by University of Pennsylvania:
opioid addiction
opioid treatment
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Opioid-Related Disorders
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents