Phase
Condition
Addictions
Alcohol Dependence
Alcohol Use Disorder
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male and females, 18 years of age or older.
Meets DSM-IV criteria for current diagnoses of cocaine and alcohol dependence,determined by the SCID-IV.
Used cocaine in the past 30 days and used no less than $200 of cocaine in aconsecutive 30 day period over the 90 day period prior to intake. Meets the followingdrinking criteria as measured by the Timeline Followback (TLFB) (Sobell 1995) a drankwithin 30 days of intake day, b. reports a minimum of 48 standard alcoholic (avg. 12drinks/wk) in a consecutive 30-day period over the 90-day period prior to startingintake (i.e., a minimum of 40% days drinking), and c. has 2 or more days of heavydrinking (defined as greater than 4 drinks per day in males and greater than 3 drinksper day in females) in this same pre-treatment period.
Three consecutive days of abstinence from alcohol directly prior to the day ofrandomization, determined by self-reports and confirmed by negative breathalyzertests, and a Clinical Institute Withdrawal Scale for Alcohol (CIWA-AR) (Sullivan andSellers 1989) score below eight. Subjects will be given 2 additional weeks beyond thescreening week to attain the appropriate period of alcohol abstinence prior torandomization.
Have a verifiable address of principal residence, lives a commutable distance from theTRC and agrees to attend all research visits including follow-up visits.
Speaks, understands, and prints in English
Ability to give informed consent
Exclusion
Exclusion Criteria:
Meets DSM IV criteria for dependence on any substance other than cocaine and alcohol (except nicotine and cannabis), determined by the SCID. Needs treatment with anypsychoactive medications including any anti-seizure medications (with the exception ofdiphenhydramine used sparingly, if necessary, for sleep).
Meets current or lifetime DSM-IV criteria for schizophrenia or any psychotic disorderor organic mental disorder. Subject meets current DSM-IV diagnosis of any otherclinically significant psychiatric disorder that will interfere with studyparticipation as determined by the principal investigator.
Has evidence of a history of significant hematological, pulmonary, endocrine,cardiovascular, renal or gastrointestinal disease.
Severe physical or medical illnesses such as AIDS, active hepatitis, significanthepatocellular injury as evidenced by elevated total bilirubin levels (>1.3 mg/dl), orelevated levels (over 4.5x normal) of aspartate aminotransferase (AST), and/or alanineaminotransferase (ALT). Patients with Gilberts Syndrome will not be excluded.
Use of an investigational medication in the 30 days prior to randomization.
History of prior treatment with vigabatrin
History of prior treatment with drugs with known retinotoxicity
History of visual field defects or predisposing factors, including glaucoma, severemyopia, retinal disorders, cataracts, diabetes, or uncontrolled hypertension.
Is female and tests positive on a pregnancy test, is contemplating pregnancy in thenext 6 months, is nursing, or is not using an effective contraceptive method (ifrelevant). Acceptable methods of contraception include barrier methods (diaphragm orcondom with spermicide, female condom), intrauterine progesterone contraceptivesystem, levonorgrestrel implant, and medroxyprogesterone acetate contraceptiveinjection, copper IUD, vaginal contraceptive film, cervical cap, contraceptive foam,hormonal vaginal contraceptive ring (NuvaRing®) or oral contraceptives.
Study Design
Study Description
Connect with a study center
University of Pennsylvania, Treatment Research Center
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
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