Galantamine Effects on Nicotine Responses in Smokers

Completed · Phase 1 · Has a placebo group

Conditions studied: Smoking, Tobacco Withdrawal

In brief

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/day) or placebo. These treatment periods will be separated by a 3 to 14 day washout period. During the first 3-days of each treatment period, smokers will have daily clinic visits, where they will receive study medications and any adverse effects from study medications will be monitored. Starting at 10 p.m. on Day 1 of each treatment period, subjects will refrain from smoking for approximately 2.5 days, until the experimental session on Day 4. Compliance with non-smoking will be verified by CO levels \< 10 ppm. During the experimental sessions, subjects will receive saline or 1.0 mg/70 kg of nicotine intravenously in a random, double-blind manner. The sequence of nicotine treatments will be counterbalanced among subjects such that equal number of subjects will receive saline first or nicotine first. Following each saline and nicotine treatments, physiological, subjective and cognitive measurements will be obtained

Key facts

Study ID

NCT01417429

Run by

Yale University

People needed

12

Starts

2010-03-01

Expected to finish

2011-03-01

Last updated by the study team

2015-07-08

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Department of Veterans Affairs — West Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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