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History of Changes for Study: NCT00732901
Serotonin and Addiction
Latest version (submitted March 6, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 8, 2008 None (earliest Version on record)
2 May 15, 2009 Study Status and Study Identification
3 September 4, 2009 Study Status and Study Identification
4 January 14, 2013 Sponsor/Collaborators, Study Status and Study Identification
5 May 3, 2013 Recruitment Status, Study Status and Contacts/Locations
6 January 5, 2016 Sponsor/Collaborators, Study Status, Study Identification and Study Design
7 February 23, 2016 Study Status
8 February 25, 2016 Sponsor/Collaborators and Study Status
9 April 22, 2016 Study Status and References
10 February 10, 2017 Study Status, Arms and Interventions, Outcome Measures and Results
11 June 9, 2017 Study Status and Study Identification
12 March 6, 2019 Study Status and Study Identification
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Study NCT00732901
Submitted Date:  August 8, 2008 (v1)

Open or close this module Study Identification
Unique Protocol ID: DA 024157
Brief Title: Serotonin and Addiction
Official Title: Project 1: Clinical Neurobiology of Serotonin and Addiction
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2008
Overall Status: Recruiting
Study Start: June 2008
Primary Completion: June 2012 [Anticipated]
Study Completion: June 2012 [Anticipated]
First Submitted: August 8, 2008
First Submitted that
Met QC Criteria:
August 8, 2008
First Posted: August 12, 2008 [Estimate]
Last Update Submitted that
Met QC Criteria:
August 8, 2008
Last Update Posted: August 12, 2008 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: National Institute on Drug Abuse (NIDA)
Responsible Party:
Collaborators: The University of Texas Health Science Center, Houston
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module 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.

Open or close this module Conditions
Conditions: Cocaine Dependence
Keywords: substance abuse
cocaine
impulsivity
serotonin
Remeron
Mirtzapine
Lexapro
Escatilopram
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Basic Science
Study Phase: Phase 2/Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 160 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: A
Mirtazapine
Drug: Mirtazapine
45mg daily for 5 weeks
Other Names:
  • Remeron
Experimental: B
Escitalopram
Drug: Escitalopram
20 mg daily for 5 weeks
Other Names:
  • Lexapro
Placebo Comparator: C
Placebo
Drug: Placebo
daily for 5 weeks
Open or close this module Outcome Measures
Primary Outcome Measures:
1. impulsivity
[ Time Frame: 5 weeks of treatment ]

Secondary Outcome Measures:
1. cue reactivity
[ Time Frame: 5 weeks of treatment ]

2. cocaine positive urines
[ Time Frame: 5 weeks of treatment ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 55 Years
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Central Contact Person: Ann D Garcia, MA
Telephone: 713-500-2804
Email: Ann.D.Garcia@uth.tmc.edu
Study Officials: Frederick G Moeller, MD
Principal Investigator
The University of Texas Health Science Center, Houston
Locations: United States, Texas
University of Texas Health Science Center-Houston; Substance Abuse Research Clinic
[Recruiting]
Houston, Texas, United States, 77030
Contact:Contact: Ann D Garcia, MA 713-500-2804 Ann.D.Garcia@uth.tmc.edu
Contact:Principal Investigator: Frederick G Moeller, MD
Contact:Sub-Investigator: Joy M Schmitz, PhD
Contact:Sub-Investigator: Scott Lane, PhD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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