Intervention: Baclofen
Trial phase: Phase 2
ATC code: M03BX01
SMILES: NCC(CC(=O)O)c1ccc(Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 20
Group description: Baclofen capsules: 15 mg/day (5 mg t.i.d.; titration phase) for 3 days, followed by 30 mg/day (10 mg t.i.d.; target dose) until the alcohol laboratory session; then, 15 mg/day (5 mg t.i.d.; taper down) for three additional days.
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.