Modulation of Pharmacologically Induced Alcohol Craving in Recently Detoxified Alcoholics

This is an interventional treatment trial for Alcoholism focused on measuring Chemical Stressor, Alcoholism, Yohimbine, Acamprosate, Craving Read More

• INCLUSION CRITERIA:

Subjects will be 60 recently detoxified alcoholics according to the following criteria:

• DSM-IV diagnosis of alcohol dependence on SCID, alcohol problems as primary complaint among substance use disorder, and alcohol use within the last month.
• Spielberger trait anxiety (21) score greater than 39
• Age 21-65
• Females of childbearing potential must agree to use a reliable method of birth control during the study. Reliable methods of birth control include oral contraceptives or Norplant(Registered Trademark); 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:

• People who present with significant medical problems which in the assessment of the Lead Associate Investigator contraindicate administration of any of the study drugs. Examples are patients requiring intensive medical or diagnostic management, such as uncontrolled hypertension, serious GI bleeding, major organ or body system dysfunction such as decompensated liver disease, renal failure, myocardial ischemia, congestive heart failure or cerebrovascular disease, major endocrine problems such as uncontrolled diabetes, pancreatic or thyroid disease, or glaucoma.
• People who are infected with the Human Immunodeficiency Virus (HIV).
• People with the following specific neuro-psychiatric disorders: any psychotic disorder including schizophrenia; bipolar affective disorder; or panic disorder.
• People with any other condition that impairs judgment or cognitive function to an extent that precludes them from providing informed consent or complying with treatment (incompetent individuals); or that requires management with pharmacotherapy that would make the subject ineligible for participation.
• Contraindications for acamprosate (previously exhibited hypersensitivity to acamprosate calcium or any of its components; or severe renal impairment, manifested as creatinine clearance of 30 mL/min or less.
• Contraindications for yohimbine or mCPP, such as liver or renal disease; chronic inflammation of the sexual organs or prostate gland; history of gastric and duodenal ulcers; glaucoma; hypersensitivity to yohimbine or mCPP
• People who are unlikely or unable to complete the treatment program because they become, or are likely to be, incarcerated while on the protocol.
• People who are required to receive treatment by a court of law or who are involuntarily committed to treatment.
• Pregnancy or lactation (negative pregnancy test required)
• Regular use of psychotropic medication, physician prescribed or purchased over the counter (e.g. antidepressant, lithium, antipsychotic, anxiolytic, antiepileptic, nasal decongestants in tablet form) or blood pressure medication (e.g. beta-blockers, calcium antagonists, ACE-inhibitors or AT1 antagonists) within the last 4 weeks, with the exception of benzodiazepines administered within the NIAAA program as part of alcohol withdrawal treatment. Specifically, no subject will be taken off psychoactive medications for the purpose of enrollment in this protocol.