Citalopram Effects on Craving and Dopamine Receptor Availability in Alcoholics (CECDRAAD)
Alcohol use disorders (AUDs) are highly prevalent among U.S. civilians, and even more prevalent in the U.S. Veteran population. AUDs are frequently co-morbid with depressive symptoms in psychiatric clinical populations, resulting in an increased severity of both conditions. Indeed, returning OEF/OIF Veterans have extraordinarily high rates of alcohol misuse and co-morbid psychiatric symptoms, indicating that future Veteran clinical populations will be particularly affected by AUDs. While FDA-approved medications are available to treat AUDs, their efficacy is low compared to available psychosocial treatments. Despite the lack of evidence for efficacy from controlled trials, antidepressants are frequently prescribed to clinical populations (including Veterans) with active AUDs. A better understanding of patient-level clinical variables that may confer poor response to treatment with antidepressants would allow clinicians better tools to distinguish those alcohol-dependent Veterans likely to do worse with antidepressant treatment.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
|Official Title:||Citalopram Effects on Craving and Dopamine Receptor Availability in Alcoholics|
- Craving for alcohol in type B alcohol dependence with citalopram compared to placebo [ Time Frame: 2-3 years ] [ Designated as safety issue: No ]To assess whether craving for alcohol in type B alcohol dependence is affected by iv citalopram, compared to placebo.
- Striatal dopamine receptor availability in type B alcohol dependence with citalopram, compared to placebo [ Time Frame: 2-3 years ] [ Designated as safety issue: No ]To assess whether striatal dopamine receptor availability in type B alcohol dependence is affected by iv citalopram, compared to placebo.
|Study Start Date:||April 2014|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Placebo Comparator: Arm 1
Intravenous citalopram, 40 mg vs. saline control, in a double-blind, crossover study, with infusion days at least 2 weeks apart.
Active Comparator: citalopram infusion
40 mg citalopram in 250 ml saline infused over 1 hour, in a double-blind, crossover study, with infusion days at least 2 weeks apart.
citalopram, 40 mg IV, vs. saline control, each to be administered in a double-blinded, within-subjects design.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01657760
|Contact: Todd S Zorick, MD PhD||Todd.Zorick@va.gov|
|Contact: Arthur L Brody, MDfirstname.lastname@example.org|
|United States, California|
|VA Greater Los Angeles Healthcare System, West Los Angeles, CA||Recruiting|
|West Los Angeles, California, United States, 90073|
|Contact: Todd S Zorick, MD PhD Todd.Zorick@va.gov|
|Contact: Arthur L Brody, MD email@example.com|
|Principal Investigator: Todd S. Zorick, MD PhD|
|Principal Investigator:||Todd S. Zorick, MD PhD||VA Greater Los Angeles Healthcare System, West Los Angeles, CA|