Clinical Neurobiology of Serotonin and Addiction

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
F. Gerald Moeller, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00732901
First received: August 8, 2008
Last updated: May 3, 2013
Last verified: January 2013
  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: Mirtazapine
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • impulsivity [ Time Frame: 5 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cue reactivity [ Time Frame: 5 weeks of treatment ] [ Designated as safety issue: No ]
  • cocaine positive urines [ Time Frame: 5 weeks of treatment ] [ Designated as safety issue: No ]

Estimated 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
Mirtazapine
Drug: Mirtazapine
45mg daily for 5 weeks
Other Name: Remeron
Experimental: B
Escitalopram
Drug: Escitalopram
20 mg daily for 5 weeks
Other Name: Lexapro
Placebo Comparator: C
Placebo
Drug: Placebo
daily for 5 weeks
Other Name: Placebo

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
Genders Eligible for Study:   Both
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
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

No publications provided

Responsible Party: F. Gerald Moeller, Professor - Psychiatry, Behavioral Sciences, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00732901     History of Changes
Other Study ID Numbers: DA 024157, P20DA024157, P20 DA024157
Study First Received: August 8, 2008
Last Updated: May 3, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
substance abuse
cocaine
impulsivity
serotonin
Remeron
Mirtzapine
Lexapro
Escatilopram

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

ClinicalTrials.gov processed this record on August 21, 2014