Back to resultsClinical Neurobiology of Serotonin and Addiction
Primary Purpose
Cocaine Dependence
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Escitalopram
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Cocaine Dependence focused on measuring substance abuse, cocaine, impulsivity, serotonin, Remeron, Mirtzapine, Lexapro, Escatilopram
Eligibility 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:
- 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.
Sites / Locations
- University of Texas Health Science Center-Houston; Substance Abuse Research Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
A (escitalopram)
B (placebo)
Arm Description
Escitalopram
Placebo
Outcomes
Primary Outcome Measures
Immediate Memory Task
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.
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
Number of urine drug screens positive for cocaine metabolite benzoylecgonine.
Full Information
NCT ID
NCT00732901
First Posted
August 8, 2008
Last Updated
March 6, 2019
Sponsor
Virginia Commonwealth University
Collaborators
National Institute on Drug Abuse (NIDA), The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT00732901
Brief Title
Clinical Neurobiology of Serotonin and Addiction
Official Title
Project 1: Clinical Neurobiology of Serotonin and Addiction
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
National Institute on Drug Abuse (NIDA), The University of Texas Health Science Center, Houston
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence
Keywords
substance abuse, cocaine, impulsivity, serotonin, Remeron, Mirtzapine, Lexapro, Escatilopram
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A (escitalopram)
Arm Type
Experimental
Arm Description
Escitalopram
Arm Title
B (placebo)
Arm Type
Experimental
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
Lexapro
Intervention Description
Escitalopram: once daily 10 mg on days 1-3, 20 mg on days 4-24 and 10 mg on days 25-28
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Once daily days 1-28
Primary Outcome Measure Information:
Title
Immediate Memory Task
Description
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.
Time Frame
after acute dose and after chronic administration
Secondary Outcome Measure Information:
Title
Attentional Bias as Measured by the Cocaine Stroop Task.
Description
Attentional bias is the difference in reaction time to cocaine related words and neutral words. A slower reaction time indicates greater attentional bias.
Time Frame
5 weeks of treatment
Title
Cocaine Positive Urines
Description
Number of urine drug screens positive for cocaine metabolite benzoylecgonine.
Time Frame
5 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederick G Moeller, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Science Center-Houston; Substance Abuse Research Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21204739
Citation
Liu S, Lane SD, Schmitz JM, Waters AJ, Cunningham KA, Moeller FG. Relationship between attentional bias to cocaine-related stimuli and impulsivity in cocaine-dependent subjects. Am J Drug Alcohol Abuse. 2011 Mar;37(2):117-22. doi: 10.3109/00952990.2010.543204. Epub 2011 Jan 5.
Results Reference
result
PubMed Identifier
24618688
Citation
Anastasio NC, Liu S, Maili L, Swinford SE, Lane SD, Fox RG, Hamon SC, Nielsen DA, Cunningham KA, Moeller FG. Variation within the serotonin (5-HT) 5-HT(2)C receptor system aligns with vulnerability to cocaine cue reactivity. Transl Psychiatry. 2014 Mar 11;4(3):e369. doi: 10.1038/tp.2013.131.
Results Reference
result
PubMed Identifier
23761390
Citation
Liu S, Lane SD, Schmitz JM, Cunningham KA, John VP, Moeller FG. Effects of escitalopram on attentional bias to cocaine-related stimuli and inhibitory control in cocaine-dependent subjects. J Psychopharmacol. 2013 Sep;27(9):801-7. doi: 10.1177/0269881113492898. Epub 2013 Jun 12.
Results Reference
result
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Clinical Neurobiology of Serotonin and Addiction
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