Galantamine Effects on Nicotine Responses in Smokers
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Smoking Tobacco Withdrawal |
Drug: Galantamine Drug: IV Nicotine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Galantamine Effects on Nicotine Responses in Smokers |
- Galantamine Effects on Nicotine Responses in Smokers [ Time Frame: 1 year to complete ] [ Designated as safety issue: Yes ]Urine sample and blood samples anticipated for 24 male and females
| Enrollment: | 12 |
| Study Start Date: | March 2010 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Galantamine |
Drug: Galantamine
8mg/a day or placebo
|
|
Experimental: Nicotine
Subject will be given IV Nicotine
|
Drug: IV Nicotine
1.0 mg/70 kg of nicotine against saline
|
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)
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Connecticut | |
| Department of Veterans Affairs | |
| West Haven, Connecticut, United States, 06516 | |
| Principal Investigator: | Mehmet Sofuoglu, M.D., Ph.D. | Yale University |
More Information
No publications provided
| Responsible Party: | Mehmet Sofuoglu, M.D., Ph.D., Yale University |
| ClinicalTrials.gov Identifier: | NCT01417429 History of Changes |
| Other Study ID Numbers: | HIC1001006222 |
| Study First Received: | April 5, 2011 |
| Last Updated: | August 12, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Yale University:
|
galantamine subjective nicotine tobacco withdrawal symptoms nicotine |
Additional relevant MeSH terms:
|
Substance Withdrawal Syndrome Smoking Substance-Related Disorders Mental Disorders Habits Galantamine Nicotine Nicotine polacrilex Parasympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Nootropic Agents Central Nervous System Agents Therapeutic Uses Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents Ganglionic Stimulants Nicotinic Agonists Cholinergic Agonists Central Nervous System Stimulants |
ClinicalTrials.gov processed this record on May 21, 2013