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NCT01657760 · ClinicalTrials.gov registry record · Phase 1
Citalopram Effects on Craving and Dopamine Receptor Availability in Alcoholics
A Phase 1 study of Alcohol Dependence, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
- 1
- Study location
NCT01657760: Completed Phase 1 study of Alcohol Dependence, sponsored by VA Office of Research and Development.
NCT01657760 is a Phase 1 study of Alcohol Dependence that has completed, run by VA Office of Research and Development. The registered enrollment target is 31 participants, below the 313-participant average among 43 other Alcohol Dependence trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01657760, a Phase 1 study of Alcohol Dependence, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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 a
Conditions Studied
Interventions
- DRUG citalopram
Study Locations (1)
California
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA - West Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2014-05-01 |
| Est. Completion | 2017-09-01 |
| Phase | Phase 1 |
What the finished NCT01657760 record still lists
NCT01657760 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 313-participant average among 43 other Alcohol Dependence trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Alcohol Dependence appearing as the primary indexed condition, and to 1 intervention - of which citalopram is the first listed.
NCT01657760 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01657760 about?
NCT01657760 is a clinical study titled "Citalopram Effects on Craving and Dopamine Receptor Availability in Alcoholics". 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 Operati...
What is the current status of trial NCT01657760?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2014-05-01. Estimated completion is 2017-09-01.
What conditions does trial NCT01657760 study?
This clinical trial studies the following conditions: Alcohol Dependence.
What interventions are being tested in trial NCT01657760?
The interventions under investigation include: citalopram (DRUG).
Who is sponsoring clinical trial NCT01657760?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01657760 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alcohol Dependence
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01657760's enrollment target sits among peer trials
31 38th of 43 higher than 6 of 43 other Alcohol Dependence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcohol Dependence trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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