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Assessment of Potential Interactions Between Intravenous Cocaine and Atomoxetine - 1

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00265265
First received: December 13, 2005
Last updated: January 23, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Cocaine-Related Disorders
 Drug: Atomoxetine
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Phase 1, Double-Blind, Placebo-Controlled Multiple Dose Assessment of Potential Interactions Between Intravenous Cocaine and Atomoxetine

Resource links provided by NLM:

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

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
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
  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

Publications:

Responsible Party: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00265265     History of Changes
Other Study ID Numbers: NIDA-CPU-0010-1
Study First Received: December 13, 2005
Last Updated: January 23, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Mental Disorders
Atomoxetine
Adrenergic Uptake Inhibitors
Adrenergic Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013