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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alcohol Dependence | Drug: citalopram | Phase 1 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 31 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Basic Science |
Official Title: | Citalopram Effects on Craving and Dopamine Receptor Availability in Alcoholics |
Actual Study Start Date : | May 1, 2014 |
Actual Primary Completion Date : | August 31, 2017 |
Actual Study Completion Date : | September 1, 2017 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: placebo
Intravenous saline control, in a double-blind, crossover study, with infusion days at least 2 weeks apart.
|
Drug: citalopram
citalopram, 40 mg IV, vs. saline control, each to be administered in a double-blinded, within-subjects design. |
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.
|
Drug: citalopram
citalopram, 40 mg IV, vs. saline control, each to be administered in a double-blinded, within-subjects design. |
- Craving for Alcohol in Alcohol Dependence With Citalopram Compared to Placebo [ Time Frame: 5 minutes after 1 hour of infusion intervention ]
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.
- Striatal Dopamine Receptor Availability in Alcohol Dependence With Citalopram, Compared to Placebo [ Time Frame: 2-3 hours after 1 hour citalopram or placebo infusion ]relative binding potential of dopamine D2/3 receptor specific tracer compared to cerebellum, where there is known to be almost no dopamine receptors.

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Ages Eligible for Study: | 21 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Must be U.S. Veteran
Alcohol Dependence:
- Age between 21 and 55;
- Meeting DSM-IV diagnostic criteria for alcohol dependence;
- Report drinking at least 48 standard drinks in a 30-day period, during the 90 days before enrollment, and
- Must have had at least 2 days of heavy drinking (at least 5 drinks/day for men, 4 drinks/day for women) in the last 30 days
Healthy Control:
- Age between 21 and 55;
- No Axis I DSM-IV diagnosis (except for nicotine dependence);
- Report drinking less than 10 drinks weekly over the past 90 days prior to study entry by Timeline Followback Method (TLFB).
Exclusion Criteria:
Exclusion criteria for Alcohol Dependence:
- Current treatment for alcohol problems or a history of treatment in the 30 days before enrollment or are treatment seeking;
- A current (last 12 months) DSM-IV diagnosis of dependence on any psychoactive substances other than alcohol and nicotine.
Exclusion criteria for Healthy Controls:
- Any history of treatment for alcohol or other substance use disorders;
- Any history of DSM-IV diagnosis of dependence on any psychoactive substances other than nicotine;
- Any history of DSM-IV diagnosis of Axis I mental illness.
Exclusion criteria for all subjects:
- A current (last 12 months) DSM-IV diagnosis of schizophrenia, bipolar disorder, other psychotic disorder, eating disorder, panic disorder with or without agoraphobia;
- Current use of psychoactive drugs, other than occasional marijuana use (< 3 uses per week), as determined by a positive urine screen for narcotics, amphetamines, or sedative hypnotics;
- Serious alcohol withdrawal symptoms as indicated by a score > 10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA);
- Clinically significant physical abnormalities as indicated by physical examination, hematological laboratory assay, or urinalysis, defined as: hematology and chemistry laboratory tests that are within normal (+/- 10%) limits with the following exceptions: a) liver function tests (total bilirubin, alanine transaminase [ALT], aspartate aminotransferase [AST], and alkaline phosphatase) < 3 x the upper limit of normal, and b) kidney function tests (creatinine and BUN) < 2 x the upper limit of normal;
- A screening ECG that demonstrates anything other than normal sinus rhythm, normal conduction, and no clinically significant arrhythmias;
- History of epilepsy, seizures, or severe head trauma;
- History of alcohol intoxication delirium, alcohol withdrawal delirium or seizure, alcohol-induced persisting dementia, or alcohol-induced psychosis;
- Treatment with any of the following medications within the last 30 days prior to randomization: antidepressants, anti-convulsants, hypnotics, antipsychotics, psychomotor stimulants, or anti-anxiety agents;
- Previous treatment with citalopram discontinued due to an adverse event;
- Pregnancy, nursing, or refusal to use reliable barrier method of birth control, if female;
- Presence of metal fragments, pacemaker, or other ferromagnetic material which would prevent safe completion of an MRI scan;
- Recent history of radiation exposure which would make exposure to radiation from serial PET scans contraindicated;
- Non-zero breath-alcohol level on screening. We will exclude participants who present to study appointments intoxicated, as active alcohol intoxication may interact unpredictably with citalopram and produce unreliable results in assessments of mood or alcohol craving (e.g. Ray and Hutchison, 2007; Ray et al., 2011; see preliminary data C.2. above);
- Resting vital signs on any study visit outside of acceptable parameters: Pulse of 50-105 bpm, Blood pressures of 90-160 mm Hg systolic, 55-100 mm Hg diastolic;
- Any indication of suicidal ideation (i.e. as assessed by question 9 on the Beck Depression Inventory-II [BDI-II]), or elevated index of depressive symptoms, as evidenced by BDI-II score of 20;
- Presence in the body of a metal device (e.g., pacemaker, infusion pump, aneurysm clip, metal prosthesis or plate) that could either interfere with the acquisition of the MRI scan of the brain or for whom the MRI scan would pose a potential risk will be excluded.
- Radiation exposure: Participation in any other research study involving exposure to ionizing radiation in the past year if the total cumulative exposure from the past research studies and the current research study would exceed the limits described by the FDA in 21 CFR 361.1. Specifically, the total cumulative dose to the whole body, active blood-forming organs, lens of the eye, and gonads must remain below 5 rems, and the cumulated dose to all other organs must remain below 15 rems over the last year.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01657760
United States, California | |
VA Greater Los Angeles Healthcare System, West Los Angeles, CA | |
West Los Angeles, California, United States, 90073 |
Principal Investigator: | Todd S Zorick, MD PhD | VA Greater Los Angeles Healthcare System, West Los Angeles, CA |
Documents provided by VA Office of Research and Development:
Responsible Party: | VA Office of Research and Development |
ClinicalTrials.gov Identifier: | NCT01657760 |
Other Study ID Numbers: |
NURA-022-11F 8331171 ( Other Grant/Funding Number: VA HSR&D ) |
First Posted: | August 6, 2012 Key Record Dates |
Results First Posted: | July 23, 2019 |
Last Update Posted: | July 23, 2019 |
Last Verified: | July 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
craving dopamine citalopram ssri |
Alcoholism Alcohol-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Citalopram Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs |