Status:
COMPLETED
Clinical Neurobiology of Serotonin and Addiction
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
The University of Texas Health Science Center, Houston
Conditions:
Cocaine Dependence
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to examine the relationship between 5-HT2R function, impulsivity and cue reactivity in cocaine dependent subjects and healthy controls and examine specific effects of esci...
Detailed Description
Specific Aim 1: We will test the hypothesis that cocaine-dependent subjects will exhibit greater impulsivity than controls as determined by a battery of impulsivity measures and that impulsivity will ...
Eligibility Criteria
Inclusion
- Non-Drug Abusing Control Subjects: Male and female subjects age 18 to 55 who do not meet current or past DSM-IV criteria for any Axis I disorder including substance abuse or dependence.
- Cocaine Dependent Subjects: Male and female subjects age 18 to 55 who meet current DSM-IV criteria for cocaine dependence.
- Female subjects: a negative pregnancy test.
Exclusion
- Non-Drug Abusing Control Subjects:
- Current or past DSM-IV Axis I disorder
- Any serious non-psychiatric medical illness requiring ongoing medical treatment or which could affect the central nervous system.
- Positive HIV test.
- For female subjects: a positive pregnancy test or breast feeding.
- Concomitant use of prescription medications that could affect the central nervous system.
- Active suicidal ideation.
- Hamilton Depression or Anxiety Scale score greater than 15
- Cocaine Dependent Subjects:
- Current DSM-IV Axis I disorder other than substance abuse/dependence
- Current diagnosis of other substance dependence besides cocaine.
- Any serious non-psychiatric medical illness requiring ongoing medical treatment or which could affect the central nervous system.
- Positive HIV test.
- For female subjects: a positive pregnancy test or breast feeding.
- Concomitant use of prescription medications that could affect the central nervous system.
- Active suicidal ideation.
- Subjects within 14 days of discontinuing a monoamine oxidase inhibitor.
- Subjects with cardiac arrythmias.
- Subjects with known hypersensitivity to escitalopram or citalopram, or mirtazapine
- Hamilton Depression or Anxiety Scale score greater than 15.
- Current alcohol abuse or dependence.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00732901
Start Date
June 1 2008
End Date
February 1 2013
Last Update
March 8 2019
Active Locations (1)
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1
University of Texas Health Science Center-Houston; Substance Abuse Research Clinic
Houston, Texas, United States, 77030