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Evaluation of Atomoxetine for Cocaine Dependence: A Pilot Trial

NCT00617201 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-08-31

Study results available
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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.

Conditions

Interventions

DRUG

atomoxetine

Once daily oral dosing

DRUG

placebo

Once daily oral dosing - matched placebo

Sponsors & Collaborators

  • Eli Lilly and Company

    collaborator INDUSTRY

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Sharon Walsh

    lead OTHER

Principal Investigators

  • Sharon L Walsh, Ph.D. · University of Kentucky

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00617201 on ClinicalTrials.gov