Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
54 participants
INTERVENTIONAL
2010-02-28
2016-02-29
Brief Summary
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Detailed Description
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Aim 1: To determine whether pretreatment brain activation on fMRI while performing a Go-Nogo task predicts response to pharmacotherapy in cocaine dependent subjects.
Hypothesis related to Aim 1:
Pretreatment fMRI BOLD activation in cocaine dependent subjects during impulsive responding on the Go-Nogo task predicts 8-week outcome from medication known to enhance serotonin function (citalopram). The regression coefficient of TES on pretreatment mean BOLD activation on the Go-Nogo task will be significantly greater for the citalopram group than the placebo group.
Aim 2: To determine whether pretreatment brain activation on fMRI while performing an attentional bias (cocaine Stroop) task predicts response to pharmacotherapy in cocaine dependent subjects.
Hypothesis related to Aim 2:
Pretreatment fMRI BOLD activation in cocaine dependent subjects during cocaine related words on the cocaine Stroop task predicts 8-week outcome from medication known to enhance serotonin function (citalopram). The regression coefficient of TES on pretreatment mean BOLD activation from the cocaine Stroop task will be significantly greater for the citalopram group than the placebo group.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Medication (Citalopram 20mg)
Citalopram (20mg dose)
Citalopram
20 mg or 40 mg daily for 8 weeks
Placebo
Placebo
Placebo daily for 8 weeks
Medication (Citalopram 40mg)
Citalopram 40mg dose
Citalopram
20 mg or 40 mg daily for 8 weeks
Interventions
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Citalopram
20 mg or 40 mg daily for 8 weeks
Placebo
Placebo daily for 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Have a DSM-IV axis I psychiatric disorder or neurological disease or disorder requiring ongoing treatment and/or making study participation unsafe
3. Significant current suicidal or homicidal ideation
4. Medical conditions contraindicating citalopram pharmacotherapy (liver disease, seizure disorder, bleeding disorder, or prolonged QT interval on EKG)
5. Taking CNS active concomitant medications
6. Taking medications known to have significant drug interactions with the study medication
7. Having conditions of probation or parole requiring reports of drug use to officers of the court
8. Impending incarceration
9. Pregnant or breast feeding for female patients
10. Inability to read, write, or speak English
11. Having plans to leave the immediate geographical area within 3 months
12. Unwillingness or not competent to sign a written informed consent form
13. Individuals who have pacemakers, metal or electromechanical implants or metallic foreign bodies
14. Patients who are known to be HIV positive will not be included due to possible CNS effects of HIV.
15. Alcohol withdrawal symptoms or history of significant previous alcohol withdrawal symptoms.
18 Years
50 Years
ALL
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
National Institute on Drug Abuse (NIDA)
NIH
Virginia Commonwealth University
OTHER
Responsible Party
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Principal Investigators
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Frederick G Moeller, M.D.
Role: PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University
Locations
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Virginia Commonwealth University
Richmond, Virginia, United States
Countries
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Other Identifiers
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HM15378
Identifier Type: -
Identifier Source: org_study_id