Assessment of Potential Interactions Between Intravenous Cocaine and Atomoxetine - 1

This study is ongoing, but not recruiting participants.

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00265265

Purpose

The purpose of this study is to assess potential interactions between intravenout (i.v.) cocaine and atomoxetine (Straterra) administered orally in four escalating doses.

Condition	Intervention	Phase
Cocaine-Related Disorders	Drug: Atomoxetine	Phase I

Drug Information available for: 8-Azabicyclo(3.2.1)octane-2-carboxylic acid, 3-(benzoyloxy)-8-methyl-, methyl ester, (1R-(exo,exo))- Cocaine hydrochloride Atomoxetine Atomoxetine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety Study
Official Title:	Phase 1, Double-Blind, Placebo-Controlled Multiple Dose Assessment of Potential Interactions Between Intravenous Cocaine and Atomoxetine

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Safety
Cardiovascular responses

Secondary Outcome Measures:

Cocaine craving
pharmacokinetic assessment
Psychological Effects of Cocaine
Abuse Liability
Mood and personality assessments

Estimated Enrollment:	16
Study Start Date:	August 2005

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18-45 years of age who are not seeking treatment at the time of the study
Must be able to provide written informed consent
Must be within 20 percent of ideal body weight and weigh at least 45 kg
Must meet DSM0IV diagnostic criteria for cocaine abuse or dependence
Must currently be using cocaine as confirmed by a positive BE
If female and of child bearing potential, must agree to the use of birth control

Exclusion Criteria:

- please contact the site directly for more information

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00265265

Locations

United States, Maryland
Uniformed Services University of Health Science
Bethesda, Maryland, United States, 20814 4799

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Louis Cantilena, M.D.

Uniformed Services University of Health Science

More Information

Study ID Numbers:	NIDA-CPU-0010-1
Study First Received:	December 13, 2005
Last Updated:	October 23, 2007
ClinicalTrials.gov Identifier:	NCT00265265
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Cocaine-Related Disorders
Mental Disorders
Substance-Related Disorders

Atomoxetine
Disorders of Environmental Origin
Cocaine

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents

Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009