Status:
COMPLETED
Galantamine Effects on Nicotine Responses in Smokers
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Smoking
Tobacco Withdrawal
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This will be a 2-4 week double-blind, placebo-controlled study. Twenty four male and female smokers will first have two 4-day treatment periods, in which they will be randomized to galantamine (8 mg/d...
Detailed Description
In this double-blind, crossover study, the investigators are proposing to evaluate galantamine's effects on the subjective nicotine effects and the severity of tobacco withdrawal symptoms. Twenty four...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- female and male smokers, aged 18 to 55 years;
- history of smoking daily for the past 12 months, at least 15 cigarettes daily;
- CO level \> 10ppm;
- for women: not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods.
- Exclusion criteria:
- history of major medical illnesses including asthma or chronic obstructive lung disease, history or current gastrointestinal ulcer, hepatic or renal impairment and cardiac rhythm disturbances or other medical conditions that the study physician deems contraindicated for the subject to be in the study;
- regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and/or recent psychiatric diagnosis and treatment for Axis I disorders including major depression, bipolar affective disorder, schizophrenia and panic disorder within the past year;
- current dependence on alcohol or on drugs or treatments for drug or alcohol addiction ;
- use of drugs that slow heart rate (eg, beta-blockers), which may increase the risk of bradycardia and AV block, or NSAIDs, which may increase potential for developing ulcers/active or occult gastrointestinal bleeding;
- known allergy to galantamine
Exclusion
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01417429
Start Date
March 1 2010
End Date
March 1 2011
Last Update
July 8 2015
Active Locations (1)
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1
Department of Veterans Affairs
West Haven, Connecticut, United States, 06516