Phase 2 N=50 Randomized Quadruple-blind Treatment

Evaluation of Atomoxetine for Cocaine Dependence: A Pilot Trial

Substance Abuse

Bottom Line

View on ClinicalTrials.gov: NCT00617201 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2012

Primary outcome: Primary: % Urine Samples Negative for Cocaine — .67; .74 percentage of positive urine samples

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: atomoxetine (Drug); placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Sharon Walsh
Primary completion: Aug 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY % Urine Samples Negative for Cocaine	.67; .74	—
SECONDARY Retention	57.4; 51.6	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00617201). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.