NCT00421603

A Placebo-Controlled Study of Mixed Amphetamine Salts and Topiramate for the Treatment of Cocaine Dependence

A Randomized, Double-Blind, Placebo-Controlled Study of Mixed Amphetamine Salts (Adderall-XR) and Topiramate for the Treatment of Cocaine Dependence

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cocaine Dependence

Interventions

Type	Name	Description
DRUG	Adderall-XR and Topiramate	Adderall-XR 60mg/day and Topiramate 300mg/day
DRUG	Placebo	Placebo

Timeline

• Start date: 2007-02-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2007-01-12
• Last updated: 2019-04-24
• Results posted: 2013-02-28

Locations

1 site across 1 country: United States