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New studies into baclofen in the US

Here is a list of new studies into baclofen funded listed on the NIH site:

#1: Recruiting Baclofen for Treating Anxiety and Alcoholism
Conditions: Alcoholism; Alcohol Dependence; Alcohol Drinking Related Problems; Alcohol Drinking; Anxiety Disorder
Interventions: Drug: Baclofen; Other: Placebo
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.

#2: Recruiting Efficacy and Safety of High Dose Baclofen for Alcohol Dependence
Efficacy and Safety of High Dose Baclofen for Alcohol Dependence
This study is currently recruiting participants. (see Contacts and Locations)
Sponsor: University of North Carolina, Chapel Hill
Condition: Alcoholism
Interventions: Drug: Baclofen; Drug: Placebo

The proposed study will carefully test the hypothesis that a robust dose of baclofen (90 mg/day) has efficacy and is safe in individuals with alcohol dependence. Furthermore, the proposal will test whether an indicator of physical dependence, i.e. drinks/drinking day, predicts response to baclofen. Additionally, the proposal will examine the anti-anxiety effects of baclofen within an alcohol dependent population and ascertain whether baseline levels of anxiety predict response to baclofen.

#3: Completed: Efficacy and Tolerability of Baclofen for Alcohol Dependence
Condition: Alcohol Dependence
Interventions: Drug: baclofen; Drug: placebo; Behavioral: BRENDA counseling

#4: Completed: Combination of Naltrexone and Baclofen for Alcohol Dependence:A Pilot Study.
Condition: Alcohol Dependence
Intervention: Drug: Naltrexone, Baclofen, Placebo and Behavior Therapy

#5: Completed: Baclofen for the Treatment of Alcohol Dependence
Condition: Alcohol Dependence
Interventions: Drug: Baclofen; Drug: Placebo

#6 Completed: Has Results A Study on the Biobehavioral Mechanisms of Baclofen and Alcohol Drinking
Condition: Alcoholism
Interventions: Drug: Baclofen; Drug: Cyproheptadine

#7 Unknown: † Baclofen as Add-On to Standard Treatment of Alcohol- Dependent Patients
Condition: Alcohol Dependence
Intervention: Drug: Baclofen (as add-on to standard treatment of alcohol dependence)

#8: Active, not recruiting Baclofen for the Treatment of Alcohol Drinkers
***FRANCE CLINICAL TRIAL***
Condition: Alcoholism
Interventions: Drug: Baclofen; Drug: Placebo

***The NIH PROCESSED THIS FILE ON APRIL 19, 2015***

***FRANCE Study*** (I believe the USA is collaborating with France for this study)

#9 Completed Efficacy and Safety of Baclofen for Maintenance of Abstinence in Alcohol Dependent Patients
Condition: Alcohol Dependence
Interventions: Drug: Baclofen; Drug: Placebo (for baclofen)

#10 Completed Efficacy of Baclofen in the Treatment of Alcohol Addiction
Condition: Liver Cirrhosis, Alcoholic
Interventions: Drug: Baclofen; Drug: placebo

#11 Recruiting Baclofen in the Treatment of Alcoholic Liver Disease
Conditions: Alcoholic Liver Disease; Alcohol Dependence
Interventions: Drug: Baclofen 30mg/day; Drug: Baclofen 75mg/day; Drug: Placebo

#12 Completed ALK29-002: A Study of Baclofen Formulations in Healthy Adults
Condition: Alcohol Dependence
Interventions: Drug: Baclofen IR; Drug: Baclofen ER

#13 Recruiting Preventing Alcohol Withdrawal With Oral Baclofen
Conditions: Alcoholism; Alcohol Withdrawal
Intervention: Drug: Baclofen

#14: Preventing Alcohol Withdrawal With Oral Baclofen (BACLOFEN III)This study is currently recruiting participants. (see Contacts and Locations)
Sponsor: Essentia Health
Information provided by (Responsible Party): Jeffrey E Lyon, Essentia Health

The purpose of this study is determine if the medication baclofen can prevent the symptoms of Alcohol Withdrawal Syndrome (AWS) in hospitalized patients who may be at risk for AWS. This medication is most often used for patients who have spasticity of their muscles due to a neuromuscular disease. In several European studies, and in an earlier study at Essentia Health (NCT00597701), baclofen has been found to have a significant effect on the severity of symptoms of AWS.

#15 Recruiting Preventing Alcohol Withdrawal Syndrome With Oral Baclofen Condition: Alcohol Withdrawal Syndrome
Interventions: Drug: Baclofen; Drug: Placebo

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Discussion

2 thoughts on “New studies into baclofen in the US

  1. Greetings,

    Do you have more information on present or future studies on baclofen in the U.S.A.?

    Bud

    Like

    Posted by Bud Last | May 4, 2015, 1:05 pm
    • I am aware of study at the University of Pennsylvania into time released baclofen which has been partially funded by the Alcohol Research Foundation, a small charity in Virginia. Time release is a useful idea because of dosage issues.

      Dr. George Koob of the NIH alcohol section is following the progress of studies in France which are now going to result in the formal licensing of baclofen for alcoholism there. The studies I have listed here are the only other studies I know of but this may change if the French issue a license.

      Like

      Posted by David | May 4, 2015, 5:04 pm

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