CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 81 enrolled
Drug / intervention
Adderall-XR and Topiramate +1 moredrug
Likely dose
Adderall-XR and Topiramate 60mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00421603
NCT00421603Phase 2Completed

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

New York State Psychiatric Institute·interventional·Posted Jan 12, 2007·Updated Apr 24, 2019

In Brief

A Phase 2 clinical trial evaluating Adderall-XR and Topiramate and Placebo for Cocaine Dependence. Completed, enrolled 81 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 12, 2007
Enrollment StartFeb 1, 2007
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 19.5 years ago

Interventions

Adderall-XR and Topiramatedrug

Adderall-XR 60mg/day and Topiramate 300mg/day

Placebodrug

Placebo