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Clinical Neurobiology of Serotonin and Addiction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cocaine Dependence Drug: Escitalopram Drug: Placebo Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Project 1: Clinical Neurobiology of Serotonin and Addiction
Study Start Date : June 2008
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. Cocaine Positive Urines [ Time Frame: 5 weeks of treatment ]
    Number of urine drug screens positive for cocaine metabolite benzoylecgonine.


Eligibility Criteria
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00732901


Locations
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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
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Principal Investigator: Frederick G Moeller, MD The University of Texas Health Science Center, Houston
More Information
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Publications of Results:

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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00732901    
Other Study ID Numbers: HM15289 - 2
P20DA024157 ( U.S. NIH Grant/Contract )
DA 024157 ( Other Identifier )
First Posted: August 12, 2008    Key Record Dates
Results First Posted: March 30, 2017
Last Update Posted: March 8, 2019
Last Verified: June 2017
Keywords provided by Virginia Commonwealth University:
substance abuse
cocaine
impulsivity
serotonin
 Remeron
Mirtzapine
Lexapro
Escatilopram
Additional relevant MeSH terms:
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Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Citalopram
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
 Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs