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Baclofen for Treating Anxiety and Alcoholism

NCT01751386 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2017-09-18

Study results available
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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

  • Alcoholism
  • Alcohol Dependence
  • Alcohol Drinking Related Problems
  • Alcohol Drinking
  • Anxiety Disorder

Interventions

DRUG

Baclofen

OTHER

Placebo

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    lead NIH

Principal Investigators

  • Lorenzo Leggio, M.D. · National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-12-03
Primary Completion
2016-08-17
Completion
2016-08-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01751386 on ClinicalTrials.gov