Official Title: “Project 1: Clinical Neurobiology of Serotonin and Addiction”

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 escitalopram and mirtazapine on impulsivity and cue reactivity in human cocaine users.

Study Type: Interventional

Study Design: Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: June 2012

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 be associated with specific profiles of 5-HT2AR and/or 5-HT2CR expression in platelets. We predict that treatment of cocaine-dependent subjects with escitalopram and/or mirtazapine will reduce impulsivity and cocaine-positive urines, in concert with a normalized balance of platelet 5-HT2AR and/or 5-HT2CR expression.

Specific Aim 2: We will test the hypothesis that cocaine-dependent subjects will exhibit greater cue reactivity than controls as determined by a modified Stroop task, and that cue reactivity will be associated with specific profiles of 5-HT2AR and/or 5-HT2CR expression in platelets. We predict that treatment of cocaine-dependent subjects with escitalopram and/or mirtazapine will reduce cue reactivity and cocaine-positive urines, in concert with a normalized balance of platelet 5-HT2AR and/or 5-HT2CR expression.

Specific Aim 3: We will test the hypothesis that specific polymorphisms in the 5-HT2AR and/or 5-HT2CR will predict baseline impulsivity and/or cue reactivity as well as treatment response to serotonergic medications in cocaine-dependent subjects.

Intervention(s) in this Clinical Trial

• Drug: Escitalopram
  • 20 mg daily for 5 weeks
• Drug: Mirtazapine
  • 45mg daily for 5 weeks
• Drug: Placebo
  • daily for 5 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • Mirtazapine
• Experimental: B
  • Escitalopram
• Placebo Comparator: C
  • Placebo

Primary Measures

• impulsivity
  • Time Frame: 5 weeks of treatment
    Safety Issue?: No

Secondary Measures

• cue reactivity
  • Time Frame: 5 weeks of treatment
    Safety Issue?: No
• cocaine positive urines
  • Time Frame: 5 weeks of treatment
    Safety Issue?: No

Inclusion Criteria:

• 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 Criteria:

• Non-Drug Abusing Control Subjects:
• 1. Current or past DSM-IV Axis I disorder
• 2. Any serious non-psychiatric medical illness requiring ongoing medical treatment or which could affect the central nervous system.
• 3. Positive HIV test.
• 4. For female subjects: a positive pregnancy test or breast feeding.
• 5. Concomitant use of prescription medications that could affect the central nervous system.
• 6. Active suicidal ideation.
• 7. Hamilton Depression or Anxiety Scale score greater than 15
• Cocaine Dependent Subjects:
• 1. Current DSM-IV Axis I disorder other than substance abuse/dependence
• 2. Current diagnosis of other substance dependence besides cocaine.
• 3. Any serious non-psychiatric medical illness requiring ongoing medical treatment or which could affect the central nervous system.
• 4. Positive HIV test.
• 5. For female subjects: a positive pregnancy test or breast feeding.
• 6. Concomitant use of prescription medications that could affect the central nervous system.
• 7. Active suicidal ideation.
• 8. Subjects within 14 days of discontinuing a monoamine oxidase inhibitor.
• 9. Subjects with cardiac arrythmias.
• 10. Subjects with known hypersensitivity to escitalopram or citalopram, or mirtazapine
• 11. Hamilton Depression or Anxiety Scale score greater than 15.
• 12. Current alcohol abuse or dependence.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: National Institute on Drug Abuse (NIDA)

Overall Clinical Trial Officials and Contacts

Frederick G Moeller, MD Principal Investigator The University of Texas Health Science Center, Houston  

Overall Contact: Ann D Garcia, MA 713-500-2804 Ann.D.Garcia@uth.tmc.edu

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00732901

Study ID Number: DA 024157

ClinicalTrials.gov Identifier: NCT00732901

Health Authority: United States: Federal Government

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