A Study on the Biobehavioral Mechanisms of Baclofen and Alcohol Drinking

Brown University

Status and phase

Completed

Phase 2

Conditions

Alcoholism

Treatments

Drug: Cyproheptadine

Drug: Baclofen

Study type

Interventional

Funder types

Other

Identifiers

NCT01076283

0906000002

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

All

Ages

21 to 65 years old

Volunteers

No Healthy Volunteers

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.