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

Sponsor

University of Pennsylvania (Other)

Overall Status

Completed

CT.gov ID

NCT01882361

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

Enrollment

Location

Arms

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

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.

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:

Opiate positive urine tests; 2) HIV injecting risk.

Secondary outcomes are:

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

77 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 :

Jun 1, 2013

Actual Primary Completion Date :

Jul 31, 2020

Actual Study Completion Date :

Jul 31, 2020

Arms and Interventions

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 Names: 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

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 Names:

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

Outcome Measures

Primary Outcome Measures

Opiate positive urine tests [12 months]
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 [12 months]
Participants will show significant HIV sex risk behaviors in the 48-week vivitrol condition.

Other Outcome Measures

adverse events [12 months]
No increase in known adverse events for the vivitrol arm as seen in other studies.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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)

Investigators

Principal Investigator: George E Woody, MD, University of Pennsylvania
Principal Investigator: Tatiana Klimenko, MD, PhD, Federal Medical Research Center for Psychiatry and Narcology (FMRC)