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ClinicalTrials.gov Identifier: NCT01845961
Verified January 2016 by Abramson Cancer Center of the University of Pennsylvania. Recruitment status was: Recruiting
: May 3, 2013
Last Update Posted
: September 26, 2016
Abramson Cancer Center of the University of Pennsylvania
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
The objective of this proof-of-concept pilot study to evaluate galantaminehydrobromide extended-release (ER) as a potential smoking cessation aid in treatment-seeking smokers.
Condition or disease
Treatment-seeking Smokers, Reporting Consumption of at Least 10 CigarettesPer Day for at Least the Past 6 Months
Drug: Galantamine Hydrobromide-ER
Nicotine dependence is a major public health problem and currently available treatments are ineffective for the majority of smokers. Thus, there is an urgent need to develop and test new medications to aid in smoking cessation. Recent evidence from a genetic study of prospective smoking cessation conducted at the CIRNA suggested smoking cessation may be influenced by variationin acetylcholine levels. The proposed proof-of-concept study is a randomized, double-blind, placebo-controlled, parallel arm pilot study of the effects of the acetylcholinesterase inhibitor, galantamine (vs. placebo), on short-term abstinence among 24 treatment-seeking smokers. The primary outcome is the number of days abstinence a 7 day quit attempt. Secondary outcomes include: smoking rate during the run-up and monitored abstinence phase, medication adherence, side effects, cognitio, and smoking urges and other withdrawal symptons. The pilot data generated will be used to support an NIH grant application by a new investigatot to evaluate whether acetylcholinesterase inhibitors could be effective smoking cessation medications.
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Ages Eligible for Study:
18 Years to 60 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Must be between the ages of 18 and 60
Must report smoking at least 10 cigarettes per day for the past 6 months
Must be able to provide informed consent
Must express interest in quitting smoking in the next 2 to 6 months.
Using a scale from 0 to 100, they must rate their confidence that they will make a quit attempt in the next 6 months a 50 or higher.
Daily 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 month.
Provide a carbon monoxide (CO) breath sample reading less than 10 parts per million (ppm) at Intake.
History of substance abuse in the past 6 months and/or currently receiving treatment for substance abuse (e.g., alcohol, opioids, cocaine, marijuana, or stimulants) as determined by self-report during the phone screen and/or through the MINI during the Intake. Subjects reporting a history of substance abuse must be in remission at least 6 months or greater.
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 Intake, Baseline, or Testing Days.
A positive urine drug screen for cocaine, amphetamines, methamphetamines, benzodiazepines, PCP, methadone, barbiturates, and opiates at the Intake, Baseline, or Testing days.
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 and must agree in writing to use an approved method of contraception. Following enrollment, pregnancy tests will be conducted at the Baseline 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.
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.
Any impairment (physical and/or neurological) including visual or other impairment preventing cognitive task performance.
Uncontrolled high blood pressure (SBP>160 or DBP>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.
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 Intake).
Psychiatric Exclusion (as determined by self-report on phone screen and/or through MINI during Intake):
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, and/or bipolar disorder.
Current or past hypomanic/manic episode.
Current or history of a diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD).
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);
Current use or recent discontinuation (within the last 60 days) 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.
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.
Not planning to live in the area for the next two months.
No children under the age of 18, pregnant women, fetuses, neonates, or prisoners are included in this research study.
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 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.
Not able to effectively communicate in English (reading, writing, speaking).