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NCT01751386 · ClinicalTrials.gov registry record · Phase 2
Baclofen for Treating Anxiety and Alcoholism
A Phase 2 study of Alcohol Drinking and Alcoholism, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- Completed
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
- 1
- Study location
NCT01751386: Completed Phase 2 study of Alcohol Drinking and Alcoholism, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
NCT01751386 is a Phase 2 study of Alcohol Drinking and Alcoholism that has completed, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 39 participants, below the 630-participant average among 85 other Alcohol Drinking trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01751386, a Phase 2 study of Alcohol Drinking and Alcoholism, has completed, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: \- Baclofen is a drug used to control muscle stiffness in people with neurological diseases. Some studies suggest that baclofen may reduce alcohol craving and use. It helps to reduce anxiety in alcoholics, which in turn can help to reduce cravings. Researchers want to see if baclofen can be a safe and effective treatment for alcoholics who have high anxiety levels. Objectives: \- To see if baclofen is safe and helpful for people who have alcoholism and high anxiety levels. Eligibility: * Individuals between 21 and 65 years of age who have been diagnosed with alcoholism and anxiety issues. * Participants must not be taking anti-anxiety medication. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Tests of alcohol dependency and anxiety levels will also be given. * Participants will be divided into two groups. One group will take baclofen. The other group will have a placebo. * About 1 week after the screening visit, participants will have a study visit. They will answer questions about their behavior and mood. They will then start to take either baclofen or a placebo. Participants will take the study drug three times a day, every day. * After 1 week on the study drug, participants will have an overnight stay at the National Institutes of Health. They will have blood tests and answer questions about mood and behavior. They will also have tests that involve choosing to drink alcohol and answering more questions about cravings. * Participants will stop taking their study drug over a 3-day period. * A final follow-up visit will be required 1 week after the overnight study visit. Participants will receive information about other alcohol abuse treatment programs.
Primary Outcome
Amount of alcohol was measured as the number of mini-drinks each participant decided to drink (0-8 mini-drinks). The alcohol content of each mini-drink was calculated based on the participants' total body water, and was designed to raise the blood alcohol concentration by 0.015 g/dL.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Baclofen
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2012-12-03 |
| Est. Completion | 2016-08-17 |
| Phase | Phase 2 |
What the finished NCT01751386 record still lists
NCT01751386 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 630-participant average among 85 other Alcohol Drinking trials with a reported enrollment target (94% lower).
The record links to 5 conditions, with Alcohol Drinking appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01751386 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01751386 about?
NCT01751386 is a clinical study titled "Baclofen for Treating Anxiety and Alcoholism". Background: \- Baclofen is a drug used to control muscle stiffness in people with neurological diseases. Some studies suggest that baclofen may reduce alcohol craving and use. It helps to reduce anxiety in alcoholics, which in turn can help to reduce cravings. Researchers want to see if baclofen ca...
What is the current status of trial NCT01751386?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2012-12-03. Estimated completion is 2016-08-17.
What conditions does trial NCT01751386 study?
This clinical trial studies the following conditions: Alcohol Drinking, Alcoholism, Alcohol Dependence, Anxiety Disorder, Alcohol Drinking Related Problems.
What interventions are being tested in trial NCT01751386?
The interventions under investigation include: Placebo (OTHER), Baclofen (DRUG).
Who is sponsoring clinical trial NCT01751386?
This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01751386 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT01751386's enrollment target sits among peer trials
39 70th of 85 higher than 16 of 85 other Alcohol Drinking trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcohol Drinking 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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