Back to resultsSerotonin, Impulsivity, and Cocaine Dependence Treatment
Primary Purpose
Cocaine Dependence
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
citalopram
Sponsored by
About this trial
This is an interventional treatment trial for Cocaine Dependence focused on measuring Cocaine; citalopram; impulsivity; serotonin
Eligibility Criteria
Inclusion Criteria: male and female subjects age 18 to 50 who currently meet DSM-IV criteria for cocaine dependence. female subjects: a negative pregnancy test Exclusion Criteria: current or past DSM-IV Axis I disorder other than substance abuse/dependence any serious non-psychiatric medical illness requiring ongoing medical treatment substance dependence other than cocaine within the last 3 months negative urine drug screen for cocaine at time of testing for female subjects: a positive pregnancy test
Sites / Locations
- University of Texas - Houston Health Science Center
Outcomes
Primary Outcome Measures
The presence of cocaine metabolites in urine weekly.
Secondary Outcome Measures
Retention rate and cocaine cravings weekly.
Full Information
NCT ID
NCT00297505
First Posted
February 27, 2006
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00297505
Brief Title
Serotonin, Impulsivity, and Cocaine Dependence Treatment
Official Title
Serotonin, Impulsivity, and Cocaine Dependence Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
February 2006
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to compare the effects of citalopram versus placebo given in the context of contingency management for cocaine dependence.
Detailed Description
Cocaine dependence continues to be a significant public health problem, for which there is no FDA approved pharmacotherapy. This study is a 12-week, double blind, placebo controlled trial of citalopram for cocaine dependence. The primary outcome measure is benzoylecgonine positive urines. Secondary measures of side effects and craving are also examined.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence
Keywords
Cocaine; citalopram; impulsivity; serotonin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
120 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
citalopram
Primary Outcome Measure Information:
Title
The presence of cocaine metabolites in urine weekly.
Secondary Outcome Measure Information:
Title
Retention rate and cocaine cravings weekly.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
male and female subjects age 18 to 50 who currently meet DSM-IV criteria for cocaine dependence.
female subjects: a negative pregnancy test
Exclusion Criteria:
current or past DSM-IV Axis I disorder other than substance abuse/dependence
any serious non-psychiatric medical illness requiring ongoing medical treatment
substance dependence other than cocaine within the last 3 months
negative urine drug screen for cocaine at time of testing
for female subjects: a positive pregnancy test
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederick G Moeller, M.D.
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas - Houston Health Science Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17613964
Citation
Moeller FG, Schmitz JM, Steinberg JL, Green CM, Reist C, Lai LY, Swann AC, Grabowski J. Citalopram combined with behavioral therapy reduces cocaine use: a double-blind, placebo-controlled trial. Am J Drug Alcohol Abuse. 2007;33(3):367-78. doi: 10.1080/00952990701313686.
Results Reference
derived
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Serotonin, Impulsivity, and Cocaine Dependence Treatment
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