Effect of Galantamine on Smoking Abstinence
Condition: Nicotine Addiction
MeSH terms: Tobacco Use Disorder
Intervention: Galantamine ER
Intervention description: The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.
Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER.
Intervention MeSH terms: Galantamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Tobacco; Smoking; Galantamine

Summary:

      This is a preliminary open-label study to determine whether a medication called galantamine
      (Brand Name: Razadyne) will help smokers quit and whether it reduces cognitive problems that
      smokers experience during a quit attempt.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Smokers who are between 18 and 60 years of age who self-report smoking at least 10
             cigarettes (menthol and non-menthol) per day for at least the last 6 months.

          2. Healthy as determined by the Study Physician, based on a medical evaluation including
             medical history and physical examination, and psychiatric evaluation.

          3. Capable of giving written informed consent, which includes compliance with the
             requirements and restrictions listed in the combined consent and Health Insurance
             Portability and Accountability Act (HIPAA) form.

          4. Women of childbearing potential must consent to use a medically accepted method of
             birth control while participating in the study (e.g., condoms and spermicide, oral
             contraceptive, Depo-provera injection, contraceptive patch, tubal ligation).

        Exclusion Criteria:

          1. Smoking Behavior

               -  Use of chewing tobacco, snuff, and/or snus.

               -  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.

               -  Provide a carbon monoxide (CO) breath sample reading less than 10ppm at Medical
                  Screening or Baseline visit.

          2. Alcohol/Drugs

               -  Lifetime history of substance abuse (other than nicotine) and/or currently
                  receiving treatment for substance abuse (e.g., alcohol, opioids, cocaine,
                  stimulants, Phencyclidine (PCP), benzodiazepines, or study prohibited
                  medications/recreational drugs) as determined by self-report during the phone
                  screen and/or through the MINI during the Medical Screening.

               -  Current alcohol consumption that exceeds 25 standard drinks/week over the past 6
                  months.

               -  Providing a breath alcohol concentration (BrAC) reading of greater than or equal
                  to 0.01 at Medical Screen or Baseline sessions.

               -  A positive urine drug screen for cocaine, amphetamines, methamphetamines,
                  benzodiazepines, PCP, methadone, barbiturates, and opiates at the Medical
                  Screening, Baseline visit, and Testing days.

          3. Medical

               -  Women who are pregnant, planning a pregnancy in the next 3 months, or lactating;
                  all female subjects of child-bearing potential shall undergo a urine pregnancy
                  test prior to enrollment and must agree in writing to use an approved method of
                  contraception. Pregnancy tests will be conducted at the Medical Screening,
                  Baseline visit, and Testing days.

               -  Diagnosis of Alzheimer's Disease or dementia.

               -  Current treatment of cancer or diagnosed with cancer (except basal cell
                  carcinoma) in the past 6 months.

               -  Liver/kidney failure, peptic ulcer disease, benign prostate hypertrophy

               -  Asthma or chronic obstructive pulmonary disease (COPD)

               -  History (last 6 months) of abnormal heart rhythms, tachycardia and/or
                  cardiovascular disease (stroke, angina, heart attack).

               -  Serious or unstable disease within the past 6 months, as determined by the Study
                  Physician.

               -  Any impairment (physical and/or neurological) including visual or other
                  impairment preventing cognitive task performance.

               -  Uncontrolled high blood pressure (systolic>150 or diastolic>90)

               -  Hearing impairment, significant hearing loss (more than 20% in either ear),
                  cochlear implants, or bi-lateral hearing aids.

               -  History of brain injury.

               -  History of epilepsy or a seizure disorder.

               -  Color Blindness.

               -  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
                  Intelligence Quotient (IQ) Test (administered at Medical Screening).

          4. Psychiatric Exclusion (as determined by self-report on phone screen and/or through
             MINI during Medical Screening)

               -  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).

               -  Suicide risk score on MINI greater than 0.

               -  History or current diagnosis of schizophrenia, psychosis, or bipolar disorder.

               -  Current or past hypomanic/manic episode.

               -  Current or history of a diagnosis of Attention-Deficit/Hyperactivity Disorder
                  (ADHD).

          5. Medication

               -  Current use, recent discontinuation (within the last month) of any form of
                  smoking cessation medications (i.e., Zyban, Wellbutrin, Wellbutrin
                  sustained-release (SR), Chantix, nicotine replacement therapy).

               -  Current use, recent discontinuation (within the last 60 days) or planned use of
                  the following medications:

               -  Anti-anxiety or panic disorder medications.

               -  Anti-psychotic medications.

               -  Mood-stabilizers (Lithium, Lamictal/lamotrigine, Neurontin/gabapentin,
                  Topamax/topiramate, valproic acid, Tegretol/carbamazepine)

               -  Anti-depressants (e.g., Wellbutrin, monoamine oxidase inhibitor (MAOIs),
                  selective serotonin reuptake inhibitor (SSRIs), tricyclic antidepressants).

               -  Prescription stimulants (e.g., Provigil, Ritalin, Adderall).

               -  Systemic Steroids (e.g., Prednisone).

               -  Current use (or use in the past 60 days) of:

               -  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).

               -  Blood pressure medication (e.g., Inversine/Mecamylamine).

               -  Urinary retention medications (Duvoid/bethanechol, Proscar/finasteride,
                  Avodart/dutasteride, Dibenzyline/phenoxybenzamine, Regitine/phentolamine).

               -  Eye medication (e.g., Atropine).

               -  Daily use of:

               -  Opiate-containing medications for chronic pain (Duragesic/fentanyl patches,
                  Percocet, Oxycontin).

               -  Medication for asthma (albuterol, Serevent, Combivent, Advair, Flovent, Azmacort,
                  Symbicort).

               -  Known allergy to study medication.

               -  Participants shall be instructed to refrain from using any study prohibited drugs
                  (note - participants are allowed to take prescription medicines not in the
                  exclusion list) throughout their participation in the study.

          6. General Exclusion

               -  Current enrollment or plans to enroll in another research program in the next 2
                  months.

               -  Any medical condition, illness, disorder, or concomitant medication that could
                  compromise participant safety or treatment, as determined by the Principal
                  Investigator and/or Study Physician.

               -  Inability to provide informed consent or complete any of the study tasks as
                  determined by the Principal Investigator.

               -  Completion of cognitive testing in studies in our center within the last 6
                  months.

               -  Able to effectively communicate in English (reading, writing, speaking).

               -  Missing 2 or more consecutive sessions, or 3 or more sessions during the
                  medication period.

               -  Missing 2 or more consecutive doses during the medication period.

               -  Missing 3 or more doses throughout the medication period.