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Evaluation of Atomoxetine for Cocaine Dependence: A Pilot Trial

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ClinicalTrials.gov Identifier: NCT00617201
Recruitment Status : Completed
First Posted : February 15, 2008
Results First Posted : December 11, 2012
Last Update Posted : August 31, 2017
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Substance Abuse Drug: atomoxetine Drug: placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Atomoxetine for Cocaine Dependence: A Pilot Trial
Study Start Date : July 2007
Primary Completion Date : August 2011
Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Drug: atomoxetine
Once daily oral dosing
Other Name: Straterra
Placebo Comparator: 2
Matched Placebo
Drug: placebo
Once daily oral dosing - matched placebo

Outcome Measures

Primary Outcome Measures :
  1. % Urine Samples Negative for Cocaine [ Time Frame: Urines were collected 3 times per week (e.g., Monday, Wednesday and Friday) for 12 weeks ]
    Total % urine samples negative for benzoylecgonine over the 12-week trial

Secondary Outcome Measures :
  1. Retention [ Time Frame: 12-weeks ]
    Trial retention- those who complete the 12 week dosing period

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Seeking treatment for cocaine dependence
  • Must have used cocaine in the past 30 days

Exclusion Criteria:

  • Physical dependence on any drug requiring medical management
  • Any major medical or psychiatric disorder that would be contraindicated for participation
  • Cardiovascular disease
  • Seizures or significant head injuries
  • Currently taking atomoxetine
  • Pregnant or breast-feeding
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00617201

United States, Kentucky
Straus Research Building
Lexington, Kentucky, United States, 40502
Sponsors and Collaborators
Sharon Walsh
Eli Lilly and Company
National Institute on Drug Abuse (NIDA)
Principal Investigator: Sharon L Walsh, Ph.D. University of Kentucky
More Information

Responsible Party: Sharon Walsh, Director Center on Drug and Alcohol Research, University of Kentucky
ClinicalTrials.gov Identifier: NCT00617201     History of Changes
Other Study ID Numbers: #07-0041
R01DA022191 ( U.S. NIH Grant/Contract )
First Posted: February 15, 2008    Key Record Dates
Results First Posted: December 11, 2012
Last Update Posted: August 31, 2017
Last Verified: August 2017

Keywords provided by Sharon Walsh, University of Kentucky:

Additional relevant MeSH terms:
Substance-Related Disorders
Cocaine-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Atomoxetine Hydrochloride
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents