Effect of Galantamine on Smoking Abstinence

Completed · Phase 2

Conditions studied: Nicotine Addiction

In brief

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.

Key facts

Study ID

NCT01548638

Run by

University of Pennsylvania

People needed

13

Starts

2012-02-01

Expected to finish

2013-10-01

Last updated by the study team

2017-12-26

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Healthy as determined by the Study Physician, based on a medical evaluation including medical history and physical examination, and psychiatric evaluation.
• 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.
• 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).

You may not qualify if…

• 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.
• 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.
• 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).
• Psychiatric Exclusion (as determined by self-report on phone screen and/or through MINI during Medical Screening)

Where it is running

• Center for Interdisciplinary Research on Nicotine Addiction, School of Medicine, University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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