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NCT00106106 · ClinicalTrials.gov registry record · Phase 2

Acamprosate to Reduce Symptoms of Alcohol Withdrawal

A Phase 2 study, sponsored by National Institutes of Health Clinical Center (CC).

Completed
Registry status
Phase 2
Development phase
56
Enrollment target

NCT00106106: Completed Phase 2 study, sponsored by National Institutes of Health Clinical Center (CC).

NCT00106106 is a Phase 2 study that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 56 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00106106, a Phase 2 study, has completed, sponsored by National Institutes of Health Clinical Center (CC).

COMPLETED
Registry status
Phase 2
Development phase
56 participants
Enrollment target

Study Summary

This study will examine whether a new drug called acamprosate can be helpful for alcohol withdrawal, a result of drinking high amounts of alcohol for long periods of time. Alcohol withdrawal can cause various symptoms, including nausea or vomiting, anxiety or depression, tremor, high blood pressure, and others. During withdrawal, brain chemicals called neurotransmitters change, with some rising to abnormally high levels. These changes may contribute to alcohol craving, drinking relapse and impaired mental performance. This study will see if taking acamprosate for 4 weeks can lower the levels of neurotransmitters, such as glutamate, lessen withdrawal symptoms and decrease alcohol craving and brain damage associated with withdrawal. Healthy normal volunteers and alcohol-dependent patients between 21 and 65 years of age may be eligible for this study. Participants are admitted to the hospital for 28 days. They receive standard inpatient care for alcohol detoxification, including a medical history and physical examination, neurological evaluation, laboratory tests, nursing, nutrition, discharge planning and referrals for treatment of concomitant conditions, if needed. In addition, they are randomly assigned to take either two acamprosate or two placebo pills three times a day for 28 days and undergo the following tests and procedures: * Days 1-28: Drug treatment. Patients take acamprosate or placebo daily. Patients with severe withdrawal symptoms may also receive diazepam (Valium). Throughout their hospitalization, patients fill out questionnaires about their emotional state and personality and are interviewed by staff about their mental health, use of alcohol, cigarettes, and illicit drugs, employment, support systems and family and social relationships, and their legal status. * Days 2 and 3: Blood tests. Blood is tested for levels of the stress hormones cortisol and ACTH, which are released to excess during alcohol withdrawal. For this test, a heparin lock (thin,

Primary Outcome

The ratio of glutamate to creatine was determined using magnetic resonance spectroscopy (MRS), a technique that complements magnetic resonance imaging (MRI). MRS is used to determine the concentration of brain metabolites, such as glutamate, in brain tissue. MRS utilizes a magnetic field to look at magnetic nuclei, which absorb and re-emit electromagnetic energy in the presence of the magnetic field. By looking at the peaks in the resultant spectra the structure and concentration of metabolites

Interventions

  • PROCEDURE NMR-spectroscopy
  • DRUG Oral acamprosate

Trial Details

FieldValue
Enrollment Target 56 participants
Start Date 2005-03
Est. Completion 2010-07
Phase Phase 2

What the finished NCT00106106 record still lists

NCT00106106 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower).

The record links to 0 conditions, and to 2 interventions - of which NMR-spectroscopy is the first listed.

NCT00106106 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00106106 about?

NCT00106106 is a clinical study titled "Acamprosate to Reduce Symptoms of Alcohol Withdrawal". This study will examine whether a new drug called acamprosate can be helpful for alcohol withdrawal, a result of drinking high amounts of alcohol for long periods of time. Alcohol withdrawal can cause various symptoms, including nausea or vomiting, anxiety or depression, tremor, high blood pressure,...

What is the current status of trial NCT00106106?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2005-03. Estimated completion is 2010-07.

What interventions are being tested in trial NCT00106106?

The interventions under investigation include: NMR-spectroscopy (PROCEDURE), Oral acamprosate (DRUG).

Who is sponsoring clinical trial NCT00106106?

This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00106106's enrollment target sits among peer trials

56 1146th of 2000 higher than 848 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00106106, the US trial registry maintained by the National Library of Medicine. NCT00106106 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.