Baclofen for Treating Anxiety and Alcoholism
- 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.
Alcohol Drinking Related Problems
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
|Official Title:||A Double-Blind, Placebo-Controlled, Randomized Human Laboratory Pilot Study of Baclofen in Anxious Alcoholics|
- Alcohol drinking during the Alcohol Self-Administration, expressed as Standard Drinking Units (SDUs) will be measured as the primary outcome during the CR/ASA session. [ Time Frame: 7 years ]
- We will also explore the role of possible moderators of baclofen's effects, namely family history of alcoholism, early vs. late onset ofalcoholism, pre-treatment anxiety levels and genetic moderators. [ Time Frame: ongoing ] [ Designated as safety issue: No ]
- Secondary objectives include baclofen's effects on alcohol cue- induced responses (urge to drink, attention to cues, blood pressure,heart rate, saliva), on the subjective effects of alcohol and on anxiety levels. [ Time Frame: 1-week ] [ Designated as safety issue: No ]
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||September 2020|
|Estimated Primary Completion Date:||September 2020 (Final data collection date for primary outcome measure)|
Baclofen 10 mg t.i.d.
Placebo Comparator: Placebo
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01751386
|Contact: Lorenzo Leggio, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Lorenzo Leggio, M.D.||National Institute on Alcohol Abuse and Alcoholism (NIAAA)|