Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 28 of 590 for:    ESCITALOPRAM AND Celexa

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Brief Summary:
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 Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (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.

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

  Show Detailed Description

Layout table for study information
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.




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, California
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States, 90073
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Layout table for investigator information
Principal Investigator: Todd S Zorick, MD PhD VA Greater Los Angeles Healthcare System, West Los Angeles, CA
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:

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 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

Layout table for additional information
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
Keywords provided by VA Office of Research and Development:
craving
dopamine
citalopram
ssri
Additional relevant MeSH terms:
Layout table for MeSH terms
Dexetimide
Citalopram
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Dopamine
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents