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Clinical Neurobiology of Serotonin and Addiction

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ClinicalTrials.gov Identifier: NCT00732901
Recruitment Status : Completed
First Posted : August 12, 2008
Results First Posted : March 30, 2017
Last Update Posted : March 8, 2019
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
The University of Texas Health Science Center, Houston
Information provided by (Responsible Party):
Virginia Commonwealth University

Tracking Information
First Submitted Date  ICMJE August 8, 2008
First Posted Date  ICMJE August 12, 2008
Results First Submitted Date  ICMJE July 20, 2016
Results First Posted Date  ICMJE March 30, 2017
Last Update Posted Date March 8, 2019
Study Start Date  ICMJE June 2008
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2017)
Immediate Memory Task [ Time Frame: after acute dose and after chronic administration ]
The IMT was used to measure impulsivity. The IMT is a continuous performance test. Subjects were instructed to respond on the computer's left mouse button when a five-digit number the target stimulus appeared that was exactly like the preceding stimulus. A catch stimulus was a number that differed only slightly from the preceding number. Only one of the five digits was changed its position and value was determined randomly. Responses errors made to catch stimuli were considered commission errors or 'false alarms'. Immediate Memory Task Commission Errors to catch stimuli were the primary measure of impulsivity in this study. Scale is percentage of overall responses to a catch stimulus that were commission errors, ranging from 0 to 100. Zero would equate to no impulsivity and 100 would equate to 100% impulsive responses.
Original Primary Outcome Measures  ICMJE
 (submitted: August 8, 2008)
impulsivity [ Time Frame: 5 weeks of treatment ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2017)
  • Attentional Bias as Measured by the Cocaine Stroop Task. [ Time Frame: 5 weeks of treatment ]
    Attentional bias is the difference in reaction time to cocaine related words and neutral words. A slower reaction time indicates greater attentional bias.
  • Cocaine Positive Urines [ Time Frame: 5 weeks of treatment ]
    Number of urine drug screens positive for cocaine metabolite benzoylecgonine.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2008)
  • cue reactivity [ Time Frame: 5 weeks of treatment ]
  • Cocaine Positive Urines [ Time Frame: 5 weeks of treatment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Neurobiology of Serotonin and Addiction
Official Title  ICMJE Project 1: Clinical Neurobiology of Serotonin and Addiction
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 escitalopram and mirtazapine on impulsivity and cue reactivity in human cocaine users.
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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Cocaine Dependence
Intervention  ICMJE
  • Drug: Escitalopram
    Escitalopram: once daily 10 mg on days 1-3, 20 mg on days 4-24 and 10 mg on days 25-28
    Other Name: Lexapro
  • Drug: Placebo
    Once daily days 1-28
Study Arms  ICMJE
  • Experimental: A (escitalopram)
    Escitalopram
    Intervention: Drug: Escitalopram
  • Experimental: B (placebo)
    Placebo
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 8, 2008)
160
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00732901
Other Study ID Numbers  ICMJE HM15289 - 2
P20DA024157 ( U.S. NIH Grant/Contract )
DA 024157 ( Other Identifier )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Virginia Commonwealth University
Study Sponsor  ICMJE Virginia Commonwealth University
Collaborators  ICMJE
  • National Institute on Drug Abuse (NIDA)
  • The University of Texas Health Science Center, Houston
Investigators  ICMJE
Principal Investigator: Frederick G Moeller, MD The University of Texas Health Science Center, Houston
PRS Account Virginia Commonwealth University
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP