CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
atomoxetine +1 moredrug
Likely dose
Not stated in 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/NCT00617201
NCT00617201Phase 2Completed
CompareCT.gov

Evaluation of Atomoxetine for Cocaine Dependence: A Pilot Trial

Sharon Walsh·interventional·Posted Feb 15, 2008·Updated Aug 31, 2017

In Brief

A Phase 2 clinical trial evaluating atomoxetine and placebo for Substance Abuse. Completed, enrolled 50 participants across 1 site.

Detailed Summary

This placebo-controlled, double-blind, randomized pilot clinical trial will evaluate atomoxetine (Strattera®) for the treatment of cocaine dependence. Cocaine-dependent individuals, who are healthy and are seeking treatment for their substance abuse, will be randomized to receive either atomoxetine (n=25) or a matched-placebo (n=25) during a trial lasting 12 weeks; there will be a double-blind, ascending dose lead-in order to achieve maintenance on the assigned active dose safely. Contingency management procedures will be used to reinforce attendance and compliance with study procedures. Primary outcome measures will include urinalysis data assessing cocaine use.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSubstance Abuse
CountriesUnited States
CollaboratorsEli Lilly and Company, National Institute on Drug Abuse (NIDA)

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 15, 2008
Enrollment StartJul 1, 2007
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 18.4 years ago

Interventions

atomoxetinedrug

Once daily oral dosing

placebodrug

Once daily oral dosing - matched placebo