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Evaluation of Atomoxetine for Cocaine Dependence: A Pilot Trial

This study has been completed.
Eli Lilly and Company
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Sharon Walsh, University of Kentucky Identifier:
First received: February 5, 2008
Last updated: November 13, 2012
Last verified: November 2012
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 Intervention Phase
Substance Abuse Drug: atomoxetine Drug: placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Atomoxetine for Cocaine Dependence: A Pilot Trial

Resource links provided by NLM:

Further study details as provided by Sharon Walsh, University of Kentucky:

Primary Outcome Measures:
  • % Urine Samples Negative for Cocaine [ Time Frame: 12 weeks ]
    Total % urine samples negative for benzoylecgonine over the 12-week trial

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

Enrollment: 50
Study Start Date: July 2007
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: atomoxetine
Once daily oral dosing
Other Name: Straterra
Placebo Comparator: 2
Matched Placebo
Drug: placebo
Once daily oral dosing - matched placebo


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00617201

United States, Kentucky
Straus Research Building
Lexington, Kentucky, United States, 40502
Sponsors and Collaborators
University of Kentucky
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 Identifier: NCT00617201     History of Changes
Other Study ID Numbers: #07-0041
R01DA022191 ( US NIH Grant/Contract Award Number )
Study First Received: February 5, 2008
Results First Received: November 13, 2012
Last Updated: November 13, 2012

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
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Anesthetics, Local
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Dopamine Agents processed this record on June 23, 2017