Trial record 14 of 36 for:    " May 15, 2013":" June 14, 2013"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Pennsylvania
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01882361
First received: June 14, 2013
Last updated: March 26, 2014
Last verified: June 2013
  Purpose

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 Intervention Phase
Opiate Dependence
Human Immunodeficiency Virus
Drug: injectable naltrexone
Drug: placebo comparator
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Opioid Relapse & HIV Risk: 48 Versus 24 Weeks of Injectable Extended Release Naltrexone

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

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


Secondary Outcome Measures:
  • HIV sex risk [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Participants will show significant HIV sex risk behaviors in the 48-week vivitrol condition.


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


Estimated Enrollment: 130
Study Start Date: June 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: placebo comparator

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01882361

Contacts
Contact: George E Woody, MD 215-399-0980 ext 112 woody@tresearch.org
Contact: Sabrina A Poole, MS 215-399-0980 ext 118 spoole@tresearch.org

Locations
Russian Federation
National Research Center on Addictions Recruiting
Moscow, Russian Federation, 119002
Contact: Mariya A Vinnikova, MD, PhD    8-985-233-47-53    marya.v@mail.ru   
Principal Investigator: Mariya A Vinnikova, MD, PhD         
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: George E Woody, MD University of Pennsylvania
Principal Investigator: Evgenia A Koshkina, MD, PhD National Research Center on Addictions, RU
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01882361     History of Changes
Other Study ID Numbers: 816019, R01DA033670
Study First Received: June 14, 2013
Last Updated: March 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
opioid addiction
opioid treatment
naloxone

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Opioid-Related Disorders
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Analgesics, Opioid
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotics
Central Nervous System Depressants
Analgesics

ClinicalTrials.gov processed this record on August 19, 2014