Evaluation of Atomoxetine for Cocaine Dependence: A Pilot Trial

Sharon Walsh

Status and phase: Completed; Phase 2

Conditions: Substance Abuse

Treatments: Drug: atomoxetine; Drug: placebo

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT00617201

R01DA022191 (U.S. NIH Grant/Contract)

#07-0041

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Atomoxetine

Treatment:

Drug: atomoxetine

2

Placebo Comparator group

Description:

Matched Placebo

Treatment:

Drug: placebo