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Trial record 28 of 590 for:    ESCITALOPRAM AND Celexa

Citalopram Effects on Craving and Dopamine Receptor Availability in Alcoholics (CECDRAAD)

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ClinicalTrials.gov Identifier: NCT01657760
Recruitment Status : Completed
First Posted : August 6, 2012
Results First Posted : July 23, 2019
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition Alcohol Dependence
Intervention Drug: citalopram
Enrollment 31
Recruitment Details Alcohol-dependent (AD) and healthy control (HC) participants were screened via the SCID-IV, excluding any participants with any Axis I psychiatric diagnosis within the last 6 months (aside from and alcohol dependence in the AD group). Fourteen potential AD and seventeen potential HC participants were enrolled and screened.
Pre-assignment Details Enrolled participants who did not start study procedures either decided not to participate or failed screening.
Arm/Group Title Alcohol Dependent Citalopram First Placebo Second Alcohol Dependent Placebo First Citalopram Second Healthy Control Citalopram First Placebo Second Healthy Control Placebo First Citalopram Second
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DSM-IV alcohol dependent participants.

Qualifying participants were invited back for three subsequent visits: a structural MRI scan, and two study medication/[18F]-fallypride PET scanning days (citalopram 40 mg iv, or saline placebo, double-blinded, administered in counter-balancing order) more than 1 week apart. All completing participants had breathalyzer-confirmed exhaled alcohol concentration of 0, and low alcohol withdrawal scores (confirming no intoxication and minimal alcohol withdrawal symptoms) on all study visits (see below). On study medication/PET scanning days, the following procedures were completed in order: 1. Breathalyzer, withdrawal, and psychiatric symptomatology screening; 2. Intravenous citalopram (or saline placebo) infusion (1 h). 3. Cue-induced craving assessment (~20 minutes). 4. [18F]-fallypride PET scanning (~3 h).

DSM-IV alcohol dependent participants.

Qualifying participants were invited back for three subsequent visits: a structural MRI scan, and two study medication/[18F]-fallypride PET scanning days (citalopram 40 mg iv, or saline placebo, double-blinded, administered in counter-balancing order) more than 1 week apart. All completing participants had breathalyzer-confirmed exhaled alcohol concentration of 0, and low alcohol withdrawal scores (confirming no intoxication and minimal alcohol withdrawal symptoms) on all study visits (see below). On study medication/PET scanning days, the following procedures were completed in order: 1. Breathalyzer, withdrawal, and psychiatric symptomatology screening; 2. Intravenous citalopram (or saline placebo) infusion (1 h). 3. Cue-induced craving assessment (~20 minutes). 4. [18F]-fallypride PET scanning (~3 h).

participants with no Axis I mental illness or substance use disorder.

Same procedures as AD group

participants with no Axis I mental illness or substance use disorder.

Same procedures as AD group

Period Title: Overall Study
Started 5 7 7 7
Completed 4 6 6 4
Not Completed 1 1 1 3
Reason Not Completed
Withdrawal by Subject             0             0             0             1
Physician Decision             1             1             1             2
Arm/Group Title Alcohol Dependent Healthy Control Total
Hide Arm/Group Description DSM-IV alcohol dependent participants with no Axis I illness or substance use disorder Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
Patients with alcohol dependence and matched controls were enrolled
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
38  (7.6) 41  (7.9) 39.5  (7.8)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
2
  20.0%
5
  50.0%
7
  35.0%
Male
8
  80.0%
5
  50.0%
13
  65.0%
[1]
Measure Analysis Population Description: 31 subjects enrolled, only 20 completed the study
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 10 participants 10 participants 20 participants
White
5
  50.0%
4
  40.0%
9
  45.0%
African American
4
  40.0%
5
  50.0%
9
  45.0%
Asian
1
  10.0%
1
  10.0%
2
  10.0%
[1]
Measure Analysis Population Description: 31 enrolled, 20 completed the study
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 20 participants
10
 100.0%
10
 100.0%
20
 100.0%
1.Primary Outcome
Title Craving for Alcohol in Alcohol Dependence With Citalopram Compared to Placebo
Hide Description

To assess whether craving for alcohol in alcohol dependence is affected by iv citalopram, compared to placebo.

Cue-induced craving for alcohol was assessed using the Alcohol Urge Questionnaire, composed of 8 questions with responses on a 0 (none) to 7 (severe or highest level) which when scored provide an estimate of the level of craving for alcohol for the participant. A maximum score is thus 56, indicating the highest level of craving for alcohol, whereas the minimum score of 0 indicates no appreciable craving for alcohol.

Time Frame 5 minutes after 1 hour of infusion intervention
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Hide Analysis Population Description
All participants completed both arms
Arm/Group Title Alcohol Dependent Citalopram Infusion Alcohol Dependent Placebo Healthy Control Citalopram Infusion Healthy Control Placebo Infusion
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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: citalopram, 40 mg IV, vs. saline control, each to be administered in a double-blinded, within-subjects design.

Intravenous saline control, in a double-blind, crossover study, with infusion days at least 2 weeks apart.

citalopram: citalopram, 40 mg IV, vs. saline control, each to be administered in a double-blinded, within-subjects design.

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: citalopram, 40 mg IV, vs. saline control, each to be administered in a double-blinded, within-subjects design.

Intravenous saline control, in a double-blind, crossover study, with infusion days at least 2 weeks apart.

citalopram: citalopram, 40 mg IV, vs. saline control, each to be administered in a double-blinded, within-subjects design.

Overall Number of Participants Analyzed 10 10 10 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
21  (14.6) 30.4  (17.9) 10.8  (4.5) 10.6  (3.7)
2.Secondary Outcome
Title Striatal Dopamine Receptor Availability in Alcohol Dependence With Citalopram, Compared to Placebo
Hide Description relative binding potential of dopamine D2/3 receptor specific tracer compared to cerebellum, where there is known to be almost no dopamine receptors.
Time Frame 2-3 hours after 1 hour citalopram or placebo infusion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alcohol Dependent Citalopram Infusion Healthy Control Citalopram Infusion Alcohol Dependent Placebo Infusion Healthy Control Placebo Infusion
Hide Arm/Group Description:
DSM-IV alcohol dependent
participants with no Axis I illness or substance use disorder
DSM-IV alcohol dependent
participants with no Axis I illness or substance use disorder
Overall Number of Participants Analyzed 10 10 10 10
Mean (Standard Deviation)
Unit of Measure: striatal binding potential ratio
22.4  (4.0) 25.7  (5.1) 22.5  (3.8) 21.3  (4.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alcohol Dependent Citalopram Infusion, Healthy Control Citalopram Infusion
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments 80% power to detect difference p<0.05 two tailed
Statistical Test of Hypothesis P-Value 0.87
Comments ANOVA, uncorrected for MC.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.01
Parameter Dispersion
Type: Standard Deviation
Value: 0.03
Estimation Comments [Not Specified]
Time Frame two weeks of study procedures per participant
Adverse Event Reporting Description Adverse events were collected on all study days, both upon initial participant contact, during the study procedures, and upon completing each day's study procedures.
 
Arm/Group Title Placebo Citalopram Infusion
Hide Arm/Group Description

Intravenous saline control, in a double-blind, crossover study, with infusion days at least 2 weeks apart.

citalopram: citalopram, 40 mg IV, vs. saline control, each to be administered in a double-blinded, within-subjects design.

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: citalopram, 40 mg IV, vs. saline control, each to be administered in a double-blinded, within-subjects design.

All-Cause Mortality
Placebo Citalopram Infusion
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)      0/20 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Citalopram Infusion
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/20 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Citalopram Infusion
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/20 (35.00%)      12/20 (60.00%)    
Gastrointestinal disorders     
nausea  [1]  1/20 (5.00%)  1 8/20 (40.00%)  8
dyspepsia  [2]  1/20 (5.00%)  1 0/20 (0.00%)  0
Musculoskeletal and connective tissue disorders     
muscle tension   2/20 (10.00%)  2 2/20 (10.00%)  2
Nervous system disorders     
anxiety   1/20 (5.00%)  1 0/20 (0.00%)  0
dizziness  [3]  2/20 (10.00%)  2 5/20 (25.00%)  5
fatigue   2/20 (10.00%)  2 7/20 (35.00%)  7
insomnia  [4]  0/20 (0.00%)  0 1/20 (5.00%)  1
Indicates events were collected by systematic assessment
[1]
subjective experience of nausea
[2]
stomach upset
[3]
temporary dizziness
[4]
occurring after study medication given
A limitation of the study is the modest sample size. Due to the collinearity between smoking and alcohol dependence in the sample, we are also unable to effectively disentangle any specific effect of smoking status on any of the measures reported.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Todd Zorick
Organization: Harbor-UCLA Department of Psychiatry
Phone: 310-781-3400
EMail: tzorick@mednet.ucla.edu
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01657760     History of Changes
Other Study ID Numbers: NURA-022-11F
8331171 ( Other Grant/Funding Number: VA HSR&D )
First Submitted: July 23, 2012
First Posted: August 6, 2012
Results First Submitted: October 30, 2018
Results First Posted: July 23, 2019
Last Update Posted: July 23, 2019