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OpenTrials
Completed

NCT Number: NCT00617201

Evaluation of Atomoxetine for Cocaine Dependence: A Pilot Trial

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.

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Key information

Conditions

Substance Abuse Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Straus Research Building

Lexington, Kentucky, 40502, United States

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Atomoxetine

Drug

Once daily oral dosing

Other names: Straterra

Placebo

Drug

Once daily oral dosing - matched placebo

Primary outcomes

  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 outcomes

  1. Retention

    Time frame: 12-weeks

    Trial retention- those who complete the 12 week dosing period

Sponsors and collaborators

Lead sponsor

Sharon Walsh

Other

Collaborators

  • Eli Lilly and Company
  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Feb 15, 2008
Registry last updated
Aug 31, 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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