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Evaluation of Atomoxetine for Cocaine Dependence: A Pilot Trial

Primary Purpose

Substance Abuse

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
atomoxetine
placebo
Sponsored by
Sharon Walsh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Abuse focused on measuring cocaine, dependence, stimulants

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Straus Research Building

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Atomoxetine

Matched Placebo

Outcomes

Primary Outcome Measures

% Urine Samples Negative for Cocaine
Total % urine samples negative for benzoylecgonine over the 12-week trial

Secondary Outcome Measures

Retention
Trial retention- those who complete the 12 week dosing period

Full Information

First Posted
February 5, 2008
Last Updated
August 1, 2017
Sponsor
Sharon Walsh
Collaborators
Eli Lilly and Company, National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00617201
Brief Title
Evaluation of Atomoxetine for Cocaine Dependence: A Pilot Trial
Official Title
Evaluation of Atomoxetine for Cocaine Dependence: A Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sharon Walsh
Collaborators
Eli Lilly and Company, National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse
Keywords
cocaine, dependence, stimulants

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Atomoxetine
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Matched Placebo
Intervention Type
Drug
Intervention Name(s)
atomoxetine
Other Intervention Name(s)
Straterra
Intervention Description
Once daily oral dosing
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Once daily oral dosing - matched placebo
Primary Outcome Measure Information:
Title
% Urine Samples Negative for Cocaine
Description
Total % urine samples negative for benzoylecgonine over the 12-week trial
Time Frame
Urines were collected 3 times per week (e.g., Monday, Wednesday and Friday) for 12 weeks
Secondary Outcome Measure Information:
Title
Retention
Description
Trial retention- those who complete the 12 week dosing period
Time Frame
12-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon L Walsh, Ph.D.
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
Straus Research Building
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40502
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Atomoxetine for Cocaine Dependence: A Pilot Trial

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