drugset / Trial / NCT00421603

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

NCT00421603

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2007-02
Primary completion
2010-05
Completion
2010-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Methylphenidate Small molecule 60 mg
Comparator Topiramate Small molecule 300 mg

Indications