a study on the biobehavioral mechanisms of baclofen and alcohol drinking

Conditions: 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.

Keywords: baclofen alcoholism urge craving alcohol drinking biobehavioral mechanisms of baclofen in alcoholism