A Placebo-Controlled Study of Mixed Amphetamine Salts and Topiramate for the Treatment of Cocaine Dependence (TACT)
The proposed protocol is a double-blind, placebo-controlled outpatient study of the safety and efficacy of Adderall-XR (ER-MAS) and topiramate in the treatment of cocaine dependence. Since both of these medications have independently shown promise in helping with cocaine abuse we are proposing that together they may be even more successful in the treatment of cocaine abuse. We plan to enroll 120 subjects in a 14-week trial. The primary objective of the study is to determine the efficacy of ER-MAS and topiramate in promoting cocaine abstinence among cocaine-dependent patients. This study includes free treatment for cocaine dependence that includes medication.
Drug: Adderall-XR and Topiramate
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Study of Mixed Amphetamine Salts (Adderall-XR) and Topiramate for the Treatment of Cocaine Dependence|
- Three Weeks of Continuous Cocaine Abstinence as Measured by Urine Toxicology and Self Report [ Time Frame: 3 weeks of abstinence during 14 weeks of trial or for length of participation ] [ Designated as safety issue: No ]Cocaine use was assessed by using urine toxicology confirmed self-report. Self-reported cocaine use data was collected for each day of the study period. Urine samples were collected three times per week. A week was considered abstinence if no cocaine use was self reported during that week and if all urine samples collected that week were negative for cocaine. If a patient achieved three continuous weeks of abstinence based on this criteria they were considered cocaine abstinent in terms of this outcome measure.
- Pattern of Cocaine Use as Measured by the TimeLine Followback [ Time Frame: recorded daily for the 14 weeks of the trial or length of participation ] [ Designated as safety issue: No ]
|Study Start Date:||February 2007|
|Study Completion Date:||May 2010|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Adderall-XR and Topiramate
Adderall-XR (60 mg/day) and Topiramate (300mg/day)
Drug: Adderall-XR and Topiramate
Adderall-XR 60mg/day and Topiramate 300mg/day
Other Name: Adderall-XR and Topiramate
Placebo Comparator: Placebo
Other Name: Placebo
Specific Aim 1: To determine the efficacy of ER-MAS and topiramate in promoting cocaine abstinence among cocaine-dependent patients.
Primary Hypothesis: The proportion of participants achieving sustained cocaine abstinence (via urine toxicology) for three consecutive weeks during the study will be significantly greater for the combined pharmacotherapies group compared to the placebo group.
Hypothesis 2: The proportion of urine samples negative for cocaine metabolites will be greater in the combined pharmacotherapies group compared to the placebo group.
Hypothesis 3: The pattern of cocaine use (amount of cocaine used per day in dollars and the number of using days per week), as measured by the time-line follow-back method, will show a greater reduction in use for the combined pharmacotherapies group compared to the placebo group.
Specific Aim 2: To determine the effect of ER-MAS and topiramate on cocaine craving among cocaine-dependent patients.
Hypothesis 4: Cocaine craving symptoms will be reduced to a greater degree in the combined pharmacotherapies group compared to the placebo group.
Specific Aim 3: To explore a set of related secondary outcomes (treatment retention, global functioning, HIV risk behavior) as well as moderators and mediators potentially reflective of mechanism of action.
|United States, New York|
|New York, New York, United States, 10032|
|Principal Investigator:||Frances R Levin, M.D.||Columbia University|