A Study to Help People Quit Smoking.

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

You are invited to participate in a research study at the VA Connecticut Healthcare System (West Haven campus) that examines whether a medication called galantamine can improve your learning and memory, and also help you to quit smoking. You have been invited to participate because you currently smoke cigarettes, and want to quit smoking. If you are eligible and agree to be in the study, your participation will last for approximately 8 weeks. To determine if galantamine (8 or 16 mg) is superior to placebo a) in reducing smoking self-administration in a human laboratory model and b) improving abstinence rates at the end of 4 weeks of treatment.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Cholinesterase Inhibitors; Galantamine

Criteria

Inclusion Criteria:

• Female and male smokers, aged 18 to 55 years;

• history of smoking daily for the past 12 months, at least 10 cigarettes daily;

• in good health as verified by medical history, screening examination, and screening laboratory tests;

• for women, not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods.

Exclusion Criteria:

• History of GAL allergy;

• requirement of any form of regular psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent psychiatric history (in the past 6 months);

• serious medical illness including asthma, diabetes, bradycardia, or other arrhythmias and major cardiovascular, renal, endocrine, or hepatic disorders;

• abuse of alcohol or any other illicit or prescription drugs;

• use of any other tobacco products, including smokeless tobacco and nicotine products; and

• inability to fulfill all scheduled visits and examination procedures throughout the study period.