Clinical Neurobiology of Serotonin and Addiction
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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 |
- impulsivity [ Time Frame: 5 weeks of treatment ] [ Designated as safety issue: No ]
- 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 |
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:
- Current or past DSM-IV Axis I disorder
- Any serious non-psychiatric medical illness requiring ongoing medical treatment or which could affect the central nervous system.
- Positive HIV test.
- For female subjects: a positive pregnancy test or breast feeding.
- Concomitant use of prescription medications that could affect the central nervous system.
- Active suicidal ideation.
- Hamilton Depression or Anxiety Scale score greater than 15
Cocaine Dependent Subjects:
- Current DSM-IV Axis I disorder other than substance abuse/dependence
- Current diagnosis of other substance dependence besides cocaine.
- Any serious non-psychiatric medical illness requiring ongoing medical treatment or which could affect the central nervous system.
- Positive HIV test.
- For female subjects: a positive pregnancy test or breast feeding.
- Concomitant use of prescription medications that could affect the central nervous system.
- Active suicidal ideation.
- Subjects within 14 days of discontinuing a monoamine oxidase inhibitor.
- Subjects with cardiac arrythmias.
- Subjects with known hypersensitivity to escitalopram or citalopram, or mirtazapine
- Hamilton Depression or Anxiety Scale score greater than 15.
- Current alcohol abuse or dependence.
Contacts and Locations| United States, Texas | |
| University of Texas Health Science Center-Houston; Substance Abuse Research Clinic | |
| Houston, Texas, United States, 77030 | |
| 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 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 Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Serotonin Agents Serotonin Receptor Agonists Antidepressive Agents, Tricyclic Histamine H1 Antagonists |
ClinicalTrials.gov processed this record on May 19, 2013