Galantamine Effects on Nicotine Responses in Smokers
Condition: Smoking; Tobacco Withdrawal
Study type: Interventional
Phase: Phase 1

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/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
    

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 male and female smokers will first have two 4-day treatment
      periods, in which subjects will be randomized to galantamine (8 mg/day) or placebo. These
      treatment periods will be separated by a 3 to 14 day washout period. This range of washout
      period, while minimizing carryover medication effects between treatments, will provide
      flexibility for subjects to comply with study procedures. During study participation,
      subjects will be instructed to continue to smoke as usual during the study except the 2.5
      days of smoking abstinence before each test session. Starting at 10 p.m. on Day 1 of each
      treatment period, subjects will refrain from smoking for approximately 2.5 days, until the
      test session on Day 4. Subjects will have twice daily outpatient visits during the first 3
      days and a test session on day 4. During the outpatient visits, study medication will be
      administered and tobacco withdrawal symptoms and compliance with smoking abstinence will be
      monitored. On Day 4 of each treatment phase subjects will have a test session, where they
      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 administration, physiological, subjective and cognitive measurements will be
      obtained.

      Currently 12 subjects completed this protocol. This study is in data analysis. (April 2011)
    

Intervention name(s): Galantamine; IV Nicotine
Intervention type(s): Drug; Drug
Intervention description(s): 8mg/a day or placebo; 1.0 mg/70 kg of nicotine against saline
Other intervention name(s): Razadyne, Razadyne ER; liquid nicotine
Intervention MeSH terms: Galantamine; Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: galantamine; subjective nicotine; tobacco withdrawal symptoms; nicotine