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| ID | Type | Description | Link |
|---|---|---|---|
| P20DA024157 | U.S. NIH Grant/Contract | View source | |
| DA 024157 | Other Identifier |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| The University of Texas Health Science Center, Houston | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A (escitalopram) | Experimental | Escitalopram |
|
| B (placebo) | Experimental | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Escitalopram | Drug | Escitalopram: once daily 10 mg on days 1-3, 20 mg on days 4-24 and 10 mg on days 25-28 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | after acute dose and after chronic administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 weeks of treatment |
| Cocaine Positive Urines |
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Inclusion Criteria:
Exclusion Criteria:
Non-Drug Abusing Control Subjects:
Cocaine Dependent Subjects:
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| Name | Affiliation | Role |
|---|---|---|
| Frederick G Moeller, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center-Houston; Substance Abuse Research Clinic | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21204739 | Result | 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. | |
| 24618688 | Result | 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. |
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The enrollment number was the number of participants who signed the informed consent. The Participants who Started in the Participant flow module were number of participants who completed the screening and met inclusion criteria to start medication.
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| ID | Title | Description |
|---|---|---|
| FG000 | A (Escitalopram) | Escitalopram Escitalopram: once daily 10 mg on days 1-3, 20 mg on days 4-24 and 10 mg on days 25-28 |
| FG001 | B (Placebo) | Placebo Placebo: once daily for days 1-28 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | A (Escitalopram) | Escitalopram: once daily 10 mg on days 1-3, 20 mg on days 4-24 and 10 mg on days 25-28 |
| BG001 | B (Placebo) | Placebo once daily for days 1-28 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Numerical data values are not accessible because PI transferred institutions. See references. | Posted | after acute dose and after chronic administration |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A (Escitalopram) | Escitalopram Escitalopram: once daily 10 mg on days 1-3, 20 mg on days 4-24 and 10 mg on days 25-28 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| F. Gerard Moeller | Virginia Commonwealth University | 804-828-4134 | fgmoeller@vcu.edu |
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| ID | Term |
|---|---|
| D019970 | Cocaine-Related Disorders |
| D019966 | Substance-Related Disorders |
| D007175 | Impulsive Behavior |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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| Placebo | Drug | Once daily days 1-28 |
|
Number of urine drug screens positive for cocaine metabolite benzoylecgonine. |
| 5 weeks of treatment |
| 23761390 | Result | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| A (Escitalopram) |
Escitalopram Escitalopram: 10 mg daily for days 1-3, 20mg daily for days 4-24, and 10mg daily for days 25-28 |
| OG001 | B (Placebo) | Placebo Placebo: daily for days 1-28 |
|
| Secondary | 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. | Posted | Mean | Standard Deviation | milliseconds | 5 weeks of treatment |
|
|
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| Secondary | Cocaine Positive Urines | Number of urine drug screens positive for cocaine metabolite benzoylecgonine. | Posted | Number | Positive urine drug screens | 5 weeks of treatment |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | B (Placebo) | Placebo Placebo: once daily for days 1-28 | 0 | 12 | 0 | 12 |
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| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Chronic Day 1 |
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| Chronic Day 2 |
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| Chronic Day 3 |
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| Chronic Day 4 |
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