Evaluation of Atomoxetine for Cocaine Dependence: A Pilot Trial
2 other identifiers
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2007
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 5, 2008
CompletedFirst Posted
Study publicly available on registry
February 15, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedResults Posted
Study results publicly available
December 11, 2012
CompletedAugust 31, 2017
August 1, 2017
4.1 years
February 5, 2008
November 13, 2012
August 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
% Urine Samples Negative for Cocaine
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 Outcomes (1)
Retention
12-weeks
Study Arms (2)
1
EXPERIMENTALAtomoxetine
2
PLACEBO COMPARATORMatched Placebo
Interventions
Eligibility Criteria
You may qualify if:
- Seeking treatment for cocaine dependence
- Must have used cocaine in the past 30 days
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sharon Walshlead
- Eli Lilly and Companycollaborator
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
Straus Research Building
Lexington, Kentucky, 40502, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Sharon Walsh
- Organization
- University of Kentucky
Study Officials
- PRINCIPAL INVESTIGATOR
Sharon L Walsh, Ph.D.
University of Kentucky
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director Center on Drug and Alcohol Research
Study Record Dates
First Submitted
February 5, 2008
First Posted
February 15, 2008
Study Start
July 1, 2007
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
August 31, 2017
Results First Posted
December 11, 2012
Record last verified: 2017-08