Effect of Galantamine on Short-term Abstinence

Exclusion Criteria

• •1. Smoking behavior
• •1. Use of chewing tobacco, snuff, and/or snus.
• •2. Current enrollment in a smoking cessation program, or use of other smoking cessation medications in the last month or plans to do either in the next 2 months.
• •3. Provide a carbon monoxide (CO) breath sample reading less than 10 parts per million (ppm) at either the Intake or Baseline visits.
• •2. Alcohol/Drugs
• •1. Lifetime history of substance abuse (other than nicotine) and/or currently receiving treatment for substance abuse (e.g., alcohol, opioids, cocaine, stimulants, PCP, benzodiazepines, or study-prohibited medications/recreational drugs) as determined by self-report during the phone screen and/or through the MINI during the Intake visit.
• •2. Current alcohol consumption that exceeds 25 standard drinks/week over the past 6 months.
• •3. Providing a breath alcohol concentration (BrAC) reading of greater than or equal to 0.01 at the Intake, Baseline, or Testing Days.
• •4. A positive urine drug screen for cocaine, amphetamines, methamphetamines, benzodiazepines, PCP, methadone, barbiturates, and opiates at the Intake visit, Baseline visit, or the Testing days.
• •3. Medical
• •1. Women who are pregnant, planning a pregnancy in the next 3 months, or lactating; all female subjects shall undergo a urine pregnancy test at the Intake visit and must agree in writing to use an approved method of contraception. Following enrollment, pregnancy tests will be conducted at the Baseline visit and Testing days for all female subjects of child-bearing potential.
• •2. Diagnosis of Alzheimer's Disease or dementia.
• •3. Current treatment of cancer or diagnosed with cancer (except basal cell carcinoma) in the past 6 months.
• •4. Liver/kidney failure, peptic ulcer disease, benign prostate hypertrophy.
• •5. Asthma or chronic obstructive pulmonary disease (COPD).
• •6. History (last 6 months) of abnormal heart rhythms, tachycardia and/or cardiovascular disease (stroke, angina, heart attack). These conditions will be evaluated on a case by case basis by the Study Physician/Health Care Provider.
• •7. Serious or unstable disease within the past 6 months, as determined by the Study Physician/Health Care Provider.
• •8. Clinically significant abnormalities within physical examination and vital signs at Medical Screen. Abnormalities will be assessed by the Study Physician/Health Care Provider and eligibility will be determined on a case-by-case basis.
• •9. Any impairment (physical and/or neurological) including visual or other impairment preventing cognitive task performance.
• •10. Uncontrolled high blood pressure (Systolic BP greater than 160 and/or Diastolic BP greater than 100).
• •11. Hearing impairment, significant hearing loss (more than 20% in either ear), cochlear implants, or bi-lateral hearing aids.
• •12. History of brain injury.
• •13. History of epilepsy or a seizure disorder.
• •14. Color Blindness.
• •15. Low or borderline intellectual functioning - determined by receiving a score of less than 90 on the Shipley Institute of Living Scale (SILS) which correlates with the Wechsler Adult Intelligence Scale-Revised (WAIS-R) Estimated IQ Test (administered at the Intake visit).
• •4. Psychiatric Exclusions (determined by self-report on phone screen and/or through the MINI during the Intake visit)
• •1. Current diagnosis of major depression. Persons with a history of major depression, in remission for 6 months or longer, are eligible, provided they are not excluded based on medications (below).
• •2. Suicide risk score on MINI greater than 0.
• •3. History or current diagnosis of schizophrenia, psychosis, and/or bipolar disorder.
• •4. Current or past hypomanic/manic episode.
• •5. Current or history of a diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD).
• •5. Medication
• •1. Current use, recent discontinuation (within the last month) of any form of smoking cessation medications (i.e., Zyban, Wellbutrin, Wellbutrin SR, Chantix, nicotine replacement therapy).
• •2. Current use or recent discontinuation (within the last 60 days) of any of the following:
• •* Anti-anxiety or panic disorder medications.
• •* Anti-psychotic medications.
• •* Mood-stabilizers (e.g., Lithium, Lamictal/lamotrigine, Neurontin/gabapentin, Topamax/topiramate, valproic acid, Tegretol/carbamazepine).
• •* Anti-depressants (e.g., Wellbutrin, MAOIs, SSRIs, tricyclic antidepressants).
• •* Prescription stimulants (e.g., Provigil, Ritalin, Adderall).
• •* Systemic Steroids (e.g., Prednisone).
• •* Alzheimer's disease medications (e.g., Acetylcholinesterase inhibitors (ACIs), Aricept/donepezil, Exelon/rivastigmine, Tacrine, or memantine).
• •* Parkinson's disease medications(e.g., Cogentin/benztropine).
• •* Irritable bowel syndrome medication (e.g., Dicylomine/Bentyl).
• •* Heart medications (e.g., quinidine or Procardia/nifedipine).
• •* Peptic ulcer disease medication (e.g, Zantac/ranitidine).
• •* Muscle relaxants (e.g., Soma/carisoprodol, Anectine/succinylcholine).
• •* Anti-fungal medication (e.g., Nizoral/ketoconazole).
• •* Anti-seizure medications (e.g., Ativan, Banzel, Carbatrol, Dilantin, Lamictal, Gabitril, Lyrica, Neurontin, Tegretol, Topamax).
• •* COPD medication (e.g., Atrovent/Ipratropium Bromide).
• •* Urinary retention medications (e.g., Duvoid/bethanechol, Proscar/finasteride, Avodart/dutasteride, Dibenzyline/phenoxybenzamine, Regitine/phentolamine).
• •* Eye medication (e.g., Atropine).
• •3. Daily use of any of the following:
• •* Opiate-containing medications for chronic pain (Duragesic/fentanyl patches, Percocet, Oxycontin).
• •* Medication for asthma (albuterol, Serevent, Combivent, Advair, Flovent, Azmacort, Symbicort).
• •4. Known drug allergy to the study medication.