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Clinical Neurobiology of Serotonin and Addiction

This study has been completed.
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
The University of Texas Health Science Center, Houston
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00732901
First received: August 8, 2008
Last updated: June 9, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention Phase
Cocaine Dependence Drug: Escitalopram Drug: Placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Basic Science
Official Title: Project 1: Clinical Neurobiology of Serotonin and Addiction

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 160
Study Start Date: June 2008
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A (escitalopram)
Escitalopram
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
Experimental: B (placebo)
Placebo
Drug: Placebo
Once daily days 1-28

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00732901

Locations
United States, Texas
University of Texas Health Science Center-Houston; Substance Abuse Research Clinic
Houston, Texas, United States, 77030
Sponsors and Collaborators
Virginia Commonwealth University
National Institute on Drug Abuse (NIDA)
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Frederick G Moeller, MD The University of Texas Health Science Center, Houston
  More Information

Additional Information:
Publications:
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00732901     History of Changes
Other Study ID Numbers: HM15289
P20DA024157 ( US NIH Grant/Contract Award Number )
DA 024157 ( Other Identifier )
Study First Received: August 8, 2008
Results First Received: July 20, 2016
Last Updated: June 9, 2017

Keywords provided by Virginia Commonwealth University:
substance abuse
cocaine
impulsivity
serotonin
Remeron
Mirtzapine
Lexapro
Escatilopram

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Serotonin
Citalopram
Dexetimide
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on June 28, 2017