Baclofen for Treating Anxiety and Alcoholism
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|ClinicalTrials.gov Identifier: NCT01751386|
Recruitment Status : Completed
First Posted : December 18, 2012
Results First Posted : August 16, 2017
Last Update Posted : September 18, 2017
- 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.
- To see if baclofen is safe and helpful for people who have alcoholism and high anxiety levels.
- 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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Alcoholism Alcohol Dependence Alcohol Drinking Related Problems Alcohol Drinking Anxiety Disorder||Drug: Baclofen Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double-Blind, Placebo-Controlled, Randomized Human Laboratory Pilot Study of Baclofen in Anxious Alcoholics|
|Study Start Date :||December 3, 2012|
|Actual Primary Completion Date :||August 17, 2016|
|Actual Study Completion Date :||August 17, 2016|
Baclofen 10 mg t.i.d.
Placebo Comparator: Placebo
- Total Amount of Alcohol Consumed During the Alcohol Self Administration (ASA) Session [ Time Frame: 2 hours ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01751386
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Lorenzo Leggio, M.D.||National Institute on Alcohol Abuse and Alcoholism (NIAAA)|