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Completed

NCT Number: NCT00265265

Assessment of Potential Interactions Between Intravenous Cocaine and Atomoxetine - 1

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

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Key information

Conditions

Cocaine-Related Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Uniformed Services University of Health Science

Bethesda, Maryland, 20814 4799, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atomoxetine

Drug

Primary outcomes

  1. Safety

  2. Cardiovascular responses

Secondary outcomes

  1. Cocaine craving

  2. pharmacokinetic assessment

  3. Psychological Effects of Cocaine

  4. Abuse Liability

  5. Mood and personality assessments

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Registry information

Official study title

Phase 1, Double-Blind, Placebo-Controlled Multiple Dose Assessment of Potential Interactions Between Intravenous Cocaine and Atomoxetine

Important dates

Study start
2005
Primary completion
2006
First posted
Dec 14, 2005
Registry last updated
Jan 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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