search
Back to results

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

Primary Purpose

Opiate Dependence, Human Immunodeficiency Virus

Status
Completed
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
injectable naltrexone
placebo comparator
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opiate Dependence focused on measuring opioid addiction, opioid treatment, naloxone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Federal Medical Research Center for Psychiatry and Narcology (FMRC)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

injectable naltrexone

placebo injection for naltrexone

Arm Description

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

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

Outcomes

Primary Outcome Measures

Opiate positive urine tests
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
Participants will show significant HIV sex risk behaviors in the 48-week vivitrol condition.

Full Information

First Posted
June 14, 2013
Last Updated
November 5, 2020
Sponsor
University of Pennsylvania
Collaborators
National Institute on Drug Abuse (NIDA)
search

1. Study Identification

Unique Protocol Identification Number
NCT01882361
Brief Title
Opioid Relapse & HIV Risk: 48 Versus 24 Weeks of Injectable Extended Release Naltrexone
Official Title
Opioid Relapse & HIV Risk: 48 Versus 24 Weeks of Injectable Extended Release Naltrexone
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
June 2013 (Actual)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
July 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: Primary outcomes will significantly favor the 48-week Vivitrol condition; Five or more secondary outcomes will favor the 48-week condition; none will favor the 24-week condition.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opiate Dependence, Human Immunodeficiency Virus
Keywords
opioid addiction, opioid treatment, naloxone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
injectable naltrexone
Arm Type
Active Comparator
Arm Description
One dose of injectable extended release naltrexone (Vivitrol), 380mg dosage, given every four weeks in a 48-week trial.
Arm Title
placebo injection for naltrexone
Arm Type
Placebo Comparator
Arm Description
placebo comparator injection starting at week 24 in a 48-week trial.
Intervention Type
Drug
Intervention Name(s)
injectable naltrexone
Other Intervention Name(s)
Vivitrol
Intervention Description
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
Intervention Name(s)
placebo comparator
Intervention Description
this placebo has no specific pharmacological activity
Primary Outcome Measure Information:
Title
Opiate positive urine tests
Description
Reduction in drug use as seen by the primary urine outcomes will significantly favor the 48-week Vivitrol condition
Time Frame
12 months
Secondary Outcome Measure Information:
Title
HIV sex risk
Description
Participants will show significant HIV sex risk behaviors in the 48-week vivitrol condition.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
adverse events
Description
No increase in known adverse events for the vivitrol arm as seen in other studies.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George E Woody, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tatiana Klimenko, MD, PhD
Organizational Affiliation
Federal Medical Research Center for Psychiatry and Narcology (FMRC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal Medical Research Center for Psychiatry and Narcology (FMRC)
City
Moscow
ZIP/Postal Code
119002
Country
Russian Federation

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs