A Study on the Biobehavioral Mechanisms of Baclofen and Alcohol Drinking
Condition: Alcoholism
MeSH terms: Alcoholism; Alcohol Drinking
Intervention: Baclofen; Cyproheptadine
Intervention description: Baclofen 10mg t.i.d.; 'active' placebo
Intervention MeSH terms: Cyproheptadine; Baclofen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 14.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: baclofen; alcoholism; urge; craving; alcohol drinking; biobehavioral mechanisms of baclofen in alcoholism

Summary:

      This pilot trial has the goal to demonstrate the feasibility of a study to test the effects
      of baclofen in a laboratory experiment using cue-reactivity and alcohol-self administration
      paradigms in non-treatment seeking alcohol-dependent subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  must be male or female between 21 and 65 years old (inclusive).

          -  participants must meet criteria for current Diagnostic and Statistical Manual of
             Mental Disorders, fourth edition, text revision (DSM-IV-TR) diagnosis of alcohol
             dependence, supported by the Structured Clinical Interview for DSM-IV-TR Axis I
             Disorders Patient Edition (SCID-I/P).

          -  participants must meet criteria for heavy drinking, defined as averaging ≥4 drinks/day
             for women and ≥5 drinks/day for men during a consecutive 30-day period within the 90
             days prior to baseline evaluation (see: Anton et al, 2006). The gender-specific
             baseline was chosen as it represents heavy drinking that exceeds empirically based
             levels of moderate alcohol use that result in alcohol-related problems for women who
             consume ≥4 drinks/day, and men who consume ≥5 drinks/day (Sanchez-Craig et al, 1995).

          -  participants must be in good health as confirmed by medical history, physical
             examination, ECG, 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.

          -  participants must be willing to take oral medication and adhere to the study
             procedures.

        Exclusion criteria:

          -  individuals expressing interest in treatment for alcoholism.

          -  pregnancy or breast feeding women or not using an adequate form of birth control

          -  positive urine drug screen at baseline for any illegal substance (a urine drug screen
             may be repeated once during the screening period).

          -  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) or Anxiety Disorder. Subjects with
             a history of suicide will be excluded.

          -  clinically significant medical abnormalities (i.e., unstable hypertension, ECG,
             bilirubin > 150% of the upper normal limit, ALT or AST elevations >300% the upper
             normal limit, creatinine clearance ≤ 60 dl/min).

          -  current use of psychotropic medications that cannot be discontinued that may have an
             effect on alcohol consumption or that may interact with baclofen or cyproheptadine.

          -  medical contraindications for use of baclofen or cyproheptadine.

          -  a history of adverse reaction or hypersensitivity to baclofen or cyproheptadine.

          -  individuals with a reasonable expectation of being institutionalized during the course
             of the trial.

          -  participants who have significant alcohol withdrawal symptoms, defined as a Clinical
             Institute Withdrawal Assessment for Alcohol (CIWA-Ar) >10.

          -  history of seizures (e.g. epilepsy).

          -  subjects who have participated in any behavioral and/or pharmacological study within
             the past 90 days.