Opioid Relapse & HIV Risk: 48 Versus 24 Weeks of Injectable Extended Release Naltrexone
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|ClinicalTrials.gov Identifier: NCT01882361|
Recruitment Status : Active, not recruiting
First Posted : June 20, 2013
Last Update Posted : September 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Opiate Dependence Human Immunodeficiency Virus||Drug: injectable naltrexone Drug: placebo comparator||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|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 :||November 2019|
|Estimated Study Completion Date :||November 2019|
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
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01882361
|Federal Medical Research Center for Psychiatry and Narcology (FMRC)|
|Moscow, Russian Federation, 119002|
|Principal Investigator:||George E Woody, MD||University of Pennsylvania|
|Principal Investigator:||Tatiana Klimenko, MD, PhD||Federal Medical Research Center for Psychiatry and Narcology (FMRC)|