Evaluation of Atomoxetine for Cocaine Dependence: A Pilot Trial

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2011-08-31

Brief Summary

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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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Detailed Description

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Conditions

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Substance Abuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Atomoxetine

Group Type EXPERIMENTAL

atomoxetine

Intervention Type DRUG

Once daily oral dosing

2

Matched Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Once daily oral dosing - matched placebo

Interventions

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atomoxetine

Once daily oral dosing

Intervention Type DRUG

placebo

Once daily oral dosing - matched placebo

Intervention Type DRUG

Other Intervention Names

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Straterra

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes