Opioid Relapse & HIV Risk: 48 Versus 24 Weeks of Injectable Extended Release Naltrexone
|Opiate Dependence Human Immunodeficiency Virus||Drug: injectable naltrexone Drug: placebo comparator||Phase 2 Phase 3|
|Study Design:||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|
- 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
- HIV sex risk [ Time Frame: 12 months ]Participants will show significant HIV sex risk behaviors in the 48-week vivitrol condition.
- adverse events [ Time Frame: 12 months ]No increase in known adverse events for the vivitrol arm as seen in other studies.
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||June 2019|
|Estimated Primary Completion Date:||June 2018 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01882361
|Contact: George E Woody, MD||215-399-0980 ext email@example.com|
|Contact: Sabrina A Poole, MS||215-399-0980 ext firstname.lastname@example.org|
|Federal Medical Research Center for Psychiatry and Narcology (FMRC)||Recruiting|
|Moscow, Russian Federation, 119002|
|Contact: Sergey Utkin, MD, PhD +79166471959 email@example.com|
|Principal Investigator: Tatiana Klimenko, MD, PhD|
|Principal Investigator:||George E Woody, MD||University of Pennsylvania|
|Principal Investigator:||Tatiana Klimenko, MD, PhD||Federal Medical Research Center for Psychiatry and Narcology (FMRC)|