CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 169 enrolled
Drug / intervention
Adderall-ER +2 moredrug
Likely dose
Adderall-ER 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/NCT01811940
NCT01811940Phase 3Completed
CompareCT.gov

Multicenter Trial of Combined Pharmacotherapy to Treat Cocaine Dependence

New York State Psychiatric Institute·interventional·Posted Mar 15, 2013·Updated Apr 24, 2019

In Brief

A Phase 3 clinical trial evaluating Adderall-ER, Topiramate, and 1 other intervention for Cocaine Dependence. Completed, enrolled 169 participants across 2 sites.

Detailed Summary

The proposed protocol is a multi-site double-blind, placebo-controlled outpatient study of the safety and efficacy of Adderall-XR (MAS-ER) and topiramate in the treatment of cocaine dependence. 198 patients will be enrolled and 176 patients randomized in a 14-week trial. The proportion of participants achieving sustained cocaine abstinence for three consecutive weeks at the end of the study will be significantly greater for the combined pharmacotherapies group compared to the placebo group.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCocaine Dependence
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 15, 2013
Enrollment StartJul 1, 2013
Primary CompletionJun 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 13.3 years ago

Interventions

Adderall-ERdrug

MAS-ER 60mg/day

Topiramatedrug

Topiramate 100 mg bid.

Placeboother

Placebo