VIVITROL as a Treatment for Cocaine and Alcohol Dependence
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00777062|
Recruitment Status : Completed
First Posted : October 22, 2008
Results First Posted : January 29, 2014
Last Update Posted : January 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cocaine Dependence Alcohol Dependence||Drug: VIVITROL (Naltrexone extended-release injectable suspension) Drug: Placebo||Phase 2|
This is a Phase II double-blind randomized controlled clinical pilot study. The exploratory objectives in the proposed study will be examined with a 2-group design to assess the efficacy of naltrexone extended-release injectable suspension (VIVITROL™) as compared to placebo. Safety measures will be collected weekly through medical management (MM) by medical practitioners, including adverse events and concomitant meds. The psychosocial treatment will be Cognitive Behavioral Coping Skills Therapy (CBT). Subjects will be 80 men and women with current DSM-IV diagnoses of alcohol dependence and cocaine dependence that will be randomized to receive either VIVITROL or placebo (40 subjects per group). All subjects will receive weekly sessions of CBT and MM. The study length for each subject is comprised of 1-3 weeks of screening, an 8-week double-blind, placebo-controlled trial with MM and CBT (medication phase), and an end of medication visit.
Primary Exploratory Objectives:
- To compare medication groups' rates of cocaine abstinence, as determined by urine assay for benzoylecgonine (BE), the primary metabolite of cocaine. This will be cross-checked against participants' self-reports of cocaine use through Time-Line Follow Back (TLFB)(Sobell & Sobell, 1992).
- To compare medication groups' rates of abstinence from drinking, and of clinically significant drinking, as measured by the TLFB.
Secondary Exploratory Objectives:
- To evaluate medication groups' reports of craving for cocaine and alcohol, as measured by scores on the Penn Alcohol Craving Scale and the Minnesota Cocaine Craving Scale during the medication treatment phase.
- To compare women's reports of medication tolerance of naltrexone extended-release injectable suspension versus high dose oral naltrexone that was reported in our recently published pilot trial of high dose naltrexone for dual cocaine and alcohol dependence (Pettinati et al., 2008).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Phase II, Randomized, Double-Blind Pilot Trial of VIVITROL® (Naltrexone for Extended-Release Injectable Suspension) for the Treatment of Cocaine and Alcohol Dependence|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||September 2013|
VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6
Drug: VIVITROL (Naltrexone extended-release injectable suspension)
VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6.
Other Name: Vivitrol
Placebo Comparator: 2
Placebo injection, 380 mg injection at the start of weeks 2 and 6.
Placebo injection at the start of weeks 2 and 6.
- Urine Assay for Benzoylecgonine (BE), the Primary Metabolite of Cocaine. [ Time Frame: 8 week medication phase ]Percentage of subjects with no cocaine use for at least 3 weeks
- Time Line Follow Back -Reported Days of Abstinence From Drinking [ Time Frame: 8 week medication phase ]Percentage of participants who were abstinent from drinking
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): NCT00777062
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Helen Pettinati, Ph.D.||University of Pennsylvania|