Back to resultsAssessment of Potential Interactions Between Intravenous Cocaine and Atomoxetine - 1
Primary Purpose
Cocaine-Related Disorders
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Atomoxetine
Sponsored by
About this trial
This is an interventional treatment trial for Cocaine-Related Disorders focused on measuring Cocaine Dependence
Eligibility Criteria
Inclusion Criteria: 18-45 years of age who are not seeking treatment at the time of the study Must be able to provide written informed consent Must be within 20 percent of ideal body weight and weigh at least 45 kg Must meet DSM0IV diagnostic criteria for cocaine abuse or dependence Must currently be using cocaine as confirmed by a positive BE If female and of child bearing potential, must agree to the use of birth control Exclusion Criteria: - please contact the site directly for more information
Sites / Locations
- Uniformed Services University of Health Science
Outcomes
Primary Outcome Measures
Safety
Cardiovascular responses
Secondary Outcome Measures
Cocaine craving
pharmacokinetic assessment
Psychological Effects of Cocaine
Abuse Liability
Mood and personality assessments
Full Information
NCT ID
NCT00265265
First Posted
December 13, 2005
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00265265
Brief Title
Assessment of Potential Interactions Between Intravenous Cocaine and Atomoxetine - 1
Official Title
Phase 1, Double-Blind, Placebo-Controlled Multiple Dose Assessment of Potential Interactions Between Intravenous Cocaine and Atomoxetine
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to assess potential interactions between intravenous (i.v.) cocaine and atomoxetine (Strattera) administered orally in four escalating doses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine-Related Disorders
Keywords
Cocaine Dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
16 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Atomoxetine
Primary Outcome Measure Information:
Title
Safety
Title
Cardiovascular responses
Secondary Outcome Measure Information:
Title
Cocaine craving
Title
pharmacokinetic assessment
Title
Psychological Effects of Cocaine
Title
Abuse Liability
Title
Mood and personality assessments
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-45 years of age who are not seeking treatment at the time of the study
Must be able to provide written informed consent
Must be within 20 percent of ideal body weight and weigh at least 45 kg
Must meet DSM0IV diagnostic criteria for cocaine abuse or dependence
Must currently be using cocaine as confirmed by a positive BE
If female and of child bearing potential, must agree to the use of birth control
Exclusion Criteria:
- please contact the site directly for more information
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis Cantilena, M.D.
Organizational Affiliation
Uniformed Services University of Health Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uniformed Services University of Health Science
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814 4799
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22987022
Citation
Cantilena L, Kahn R, Duncan CC, Li SH, Anderson A, Elkashef A. Safety of atomoxetine in combination with intravenous cocaine in cocaine-experienced participants. J Addict Med. 2012 Dec;6(4):265-73. doi: 10.1097/ADM.0b013e31826b767f.
Results Reference
result
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Assessment of Potential Interactions Between Intravenous Cocaine and Atomoxetine - 1
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