Baclofen for Treating Anxiety and Alcoholism
Condition: Alcoholism; Alcohol Dependence; Alcohol Drinking Related Problems; Alcohol Drinking; Anxiety Disorder
MeSH terms: Alcoholism; Anxiety Disorders; Alcohol Drinking
Intervention: Baclofen; Placebo
Intervention MeSH terms: Baclofen
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 39.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Addiction; Cue-Induced Craving; Craving; Anxiety; Alcohol Consumption

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.
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

          -  Must be male or female between 21 and 65 years old (inclusive).

          -  Participants must meet criteria for current DSM-IV-TR diagnosis of alcohol dependence,
             supported by the Structured Clinical Interview for DSM-IV-TR Axis I Disorders (SCID).

          -  Participants must have a Trait STAI > 39.

          -  Participants must be in good health as confirmed by medical history, physical
             examination, ECG, blood/urine lab tests.

          -  Females must be postmenopausal for at least one year, surgically sterile, or
             practicing an effective method of birth control before entry and throughout the study;
             have a negative urine pregnancy test at each visit. Reliable methods of birth control
             include oral contraceptives or Norplant ; barrier methods such as diaphragms with
             contraceptive jelly, cervical caps with contraceptive jelly, condoms with
             contraceptive foam, or intrauterine devices; a partner with a vasectomy; or abstinence
             from intercourse.

        EXCLUSION CRITERIA:

          -  Individuals expressing interest in treatment for alcoholism and/or anxiety.

          -  Pregnancy or breast feeding women or not using an adequate form of birth control

          -  Unable to provide a negative urine drug screen.

          -  Individuals diagnosed with a current substance dependence diagnosis, other than
             alcohol or nicotine.

          -  Meet DSM-IV Axis I criteria for a lifetime diagnosis of schizophrenia, bipolar
             disorder, or other psychoses.

          -  An active illness within the past 6 months of Visit 1 that meet the DSM-IV criteria
             for a diagnosis of Major Depressive Disorder (MDD). Subjects with a history of
             attempted suicide will be excluded.

          -  Clinically significant medical abnormalities (i.e., unstable hypertension, clinically
             significant ECG abnormalities, Creatinine greater than or equal to 2 mg/dL). Although
             baclofen has demonstrated a safe profile when administered to alcoholic individuals
             with liver cirrhosis, including those with Hepatitis C, this study employs the oral
             administration of alcohol. Therefore, individuals with clinically significant liver
             problems will be excluded, i.e. liver cirrhosis, AST or ALT > 5 times the upper normal
             limit (UNL), and individuals with Hepatitis B and C.

          -  Current use of psychotropic medications that cannot be discontinued and that may have
             an effect on alcohol consumption (thus confounding the results of the study) or that
             may interact with baclofen. Specifically, contraindicated medications will include:
             naltrexone, acamprosate, alcohol dehydrogenase inhibitors, topiramate, gabapentin,
             ondansetron, benzodiazepines, beta-blockers, H2-blockers, and alpha-1 blockers.

          -  Medical contraindications for use of baclofen.

          -  A history of adverse reaction or hypersensitivity to baclofen.

          -  Participants who have significant alcohol withdrawal symptoms, defined as a CIWA-Ar >
             8.

          -  History of epilepsy or alcohol-related seizures.