Human Behavioral Pharmacology Laboratory (HBPL) Study of Varenicline's Impact on Cocaine and Alcohol Craving

Exclusion Criteria

• •1. Meets DSM-IV criteria for current dependence on any substance other than nicotine, cocaine, alcohol or marijuana.
• •2. Subjects who are currently taking anti-depressant medications (e.g., SSRIs such as citalopram)
• •3. Patients who are diagnosed during screening with clinical depression using the HAM-D rating scale and present with a score \>10.
• •4. Subjects who are diagnosed with anxiety as diagnosed using the HAM-A anxiety scale with a score \>17
• •5. Subjects who meet current- or lifetime DSM-IV criteria for a psychotic disorder (e.g., schizophrenia)
• •6. Requires treatment with any psychotropic medication (e.g., antidepressant, antipsychotic, benzodiazepine, or mood stabilizing medication).
• •7. Subjects who test positive on the urine drug screen for any illicit drugs other than cocaine and marijuana during screening will be allowed a single retest. Those individuals who test positive for amphetamine during screening, given that they provide a copy of a prescription, will only be included if they can safely discontinue amphetamine use for the duration of the study. Subjects will need to provide a urine free of all illicit drugs other than cocaine and marijuana at study onset to be randomized. Subjects who test positive for any drugs other than marijuana prior to a study session will be allowed a single retest and a chance to reschedule their session. If the subject tests positive for any drug other than marijuana at the retest, their participation in the study will be terminated.
• •8. Use of any investigational medication within the past 30 days.
• •9. Concomitant use of any one of the following drugs or classes of drugs:
• •Anti-depressant drugs such as citalopram, fluoxetine; antipsychotic drugs such as haloperidol; benzodiazepines or other anxiolytic medications; Antihypertensive drugs such as Reserpine, Verapamil; Blood thinners Medications used to treat respiratory diseases such as theophylline; Trimethoprim; Cimetidine; Antiepileptic drugs (AEDs) such as phenytoin or valproic acid.
• •10. Patients with a known hypersensitivity to varenicline.
• •11. Patients with severe unstable or serious medical illness such as a seizure disorder, unstable cerebrovascular disease, bronchospastic disease, hyperthyroidism, or diabetes mellitus.
• •12. Patients with known AIDS or other serious illnesses that may require hospitalization during the study.
• •13. Female subjects who are pregnant, plan to become pregnant, are currently lactating, or are of child-bearing potential and are not using acceptable methods of birth control; acceptable methods of birth control would include:
• •1. Barrier method (diaphragm or condom)
• •2. Intrauterine progesterone contraceptive system
• •3. Levonorgesterel implant
• •4. Medroxyprogesterone acetate contraceptive injection, or
• •5. Oral contraceptives.
• •14. Patients with impaired renal function, as indicated by corrected creatinine clearance below 60 ml/min as determined by the modified Cockcroft equation (CDC, 1986).
• •15. An unacceptable liver panel (liver function tests; LFTs) that may be indicative of hepatic dysfunction.
• •16. Clinical laboratory tests (e.g., CBC, blood chemistries, urinalysis) outside normal limits, as determined by PI.
• •17. History of significant heart disease or dysfunction (e.g., an arrhythmia which required medication, Wolff Parkinson -White Syndrome, angina pectoris, documented history of myocardial infarction, heart failure).
• •18. Electrocardiography (EKG) indicative of 1st degree heart block, sinus tachycardia, left-axis deviation, non-specific ST or T-wave changes.
• •19. History of chest pain associated with cocaine use that prompted a visit to a physician.
• •20. Any medical or psychological condition that could jeopardize the subject's safe participation in the trial as determined by the PI.