Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Baclofen for Treating Anxiety and Alcoholism
NCT01751386 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01751386
The ClinicalTrials.gov registry entry for NCT01751386 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 118 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01751386 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01751386?
The interventions under investigation include: Placebo (OTHER), Baclofen (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01751386?
This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 118 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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