Effect of Galantamine on Short-term Abstinence

Completed · Phase 2 · Has a placebo group

Conditions studied: Tobacco Use Disorder

In brief

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.

Key facts

Study ID

NCT01669538

Run by

University of Pennsylvania

People needed

98

Starts

2012-08-01

Expected to finish

2017-11-01

Last updated by the study team

2019-02-15

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.
• Interest in quitting smoking in the next 2 to 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 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 10 parts per million (ppm) at either the Intake or Baseline visits.
• Alcohol/Drugs
• 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.
• 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 the Intake, Baseline, or Testing Days.
• 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.
• Medical
• 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.
• 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). These conditions will be evaluated on a case by case basis by the Study Physician/Health Care Provider.
• Serious or unstable disease within the past 6 months, as determined by the Study Physician/Health Care Provider.
• 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.
• Any impairment (physical and/or neurological) including visual or other impairment preventing cognitive task performance.
• Uncontrolled high blood pressure (Systolic BP greater than 160 and/or Diastolic BP greater than 100).
• 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 IQ Test (administered at the Intake visit).

Where it is running

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

Full record on ClinicalTrials.gov

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