Effect of Galantamine on Short-term Abstinence
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Intervention: Galantamine; Placebo
Intervention MeSH terms: Galantamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Galantamine; Nicotine Bitartrate; Nicotine Tartrate; Nicotine dependence; Tobacco Dependence

Summary:

      This is a randomized, double-blind, placebo-controlled study to test 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. Interest in quitting smoking in the next 2 to 6 months.

          3. Healthy as determined by the Study Physician, based on a medical evaluation including
             medical history and physical examination, and psychiatric evaluation.

          4. Capable of giving written informed consent, which includes compliance with the
             requirements and restrictions listed in the combined consent and HIPAA form.

          5. 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

               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.

             Subjects will be instructed to refrain from using any study prohibited
             drugs/medications (both recreational and prescription) throughout their participation
             in the study. After final eligibility is confirmed, subjects who report taking
             contraindicated medication(s) over the course of the study period may only remain
             eligible if the Study Physician and/or Principal Investigator determines that the
             contraindicated medication(s) do/did not impact the study design, data quality, and/or
             subject safety/welfare. Subjects are permitted to take necessary prescription
             medications not included within the exclusion list during the study.

          6. General exclusions

               1. Current, anticipated, or pending enrollment in another research program over the
                  next 2-3 months that could potentially affect subject safety and/or the study
                  data/design as determined by the Principal Investigator and/or Study Physician.

               2. Not planning to live in the area for the next two months.

               3. 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.

               4. Inability to provide informed consent or complete any of the study tasks as
                  determined by the Principal Investigator.

               5. Completion of neurocognitive assessments and/or use of study medication(s) at the
                  CIRNA in the past 6-months that could influence performance on study tasks as
                  determined by the Principal Investigator.

               6. Not able to effectively communicate in English (reading, writing, speaking).

               7. Missing 2 or more consecutive sessions, or 3 or more sessions during the
                  medication period.

               8. Missing 2 or more consecutive doses during the medication period.

               9. Missing 3 or more doses throughout the medication period.