CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 139 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
Adderall-XR 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/NCT00553319
NCT00553319Phase 3Completed

A Randomized, Double-Blind, Placebo-Controlled Study of Mixed Amphetamine Salts (Adderall-XR) for the Treatment of Adult Attention Deficit Hyperactivity Disorder (ADHD) and Cocaine Dependence

New York State Psychiatric Institute·interventional·Posted Nov 5, 2007·Updated Apr 24, 2019

In Brief

A Phase 3 clinical trial evaluating Placebo and Adderall-XR for Adult Attention Deficit Hyperactivity Disorder and Cocaine Dependence. Completed, enrolled 139 participants across 2 sites.

Detailed Summary

The proposed protocol is a 3 group double-blind, placebo-controlled outpatient study of the safety and efficacy of Adderall-XR (ER-MAS) in the treatment of comorbid ADHD and cocaine dependence. Since this medication has independently shown promise in helping with ADHD and cocaine abuse, we are proposing that it may be successful in the treatment of comorbid ADHD and cocaine abuse. We plan to enroll 75 subjects in a 14-week trial. The primary objectives of the study are to determine the efficacy of ER-MAS in promoting cocaine abstinence and improvement in ADHD symptomology among cocaine-dependent patients with comorbid ADHD.

Study Details

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

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 5, 2007
Enrollment StartDec 1, 2007
Primary CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 18.7 years ago

Interventions

Placebodrug

Placebo group

Adderall-XRdrug

Adderall-XR 60mg/day

Adderall-XRdrug

Adderall-XR 80mg/day