Evaluation of Atomoxetine for Cocaine Dependence: A Pilot Trial

August 1, 2017 updated by: Sharon Walsh
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40502
        • Straus Research Building

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Atomoxetine
Drug: atomoxetine
Once daily oral dosing
Other Names:
  • Straterra
Placebo Comparator: 2
Matched Placebo
Drug: placebo
Once daily oral dosing - matched placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% 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
Urines were collected 3 times per week (e.g., Monday, Wednesday and Friday) for 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention
Time Frame: 12-weeks
Trial retention- those who complete the 12 week dosing period
12-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sharon Walsh

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

February 5, 2008

First Submitted That Met QC Criteria

February 14, 2008

First Posted (Estimate)

February 15, 2008

Study Record Updates

Last Update Posted (Actual)

August 31, 2017

Last Update Submitted That Met QC Criteria

August 1, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #07-0041
  • R01DA022191 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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