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Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) Yale University Department of Veterans Affairs |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00644137 |
The goal of this study is to examine the effects of a GABA (gamma amino butyric acid)-enhancing medication, pregabalin (300 mg/day), on smoking behavior, tobacco withdrawal and cigarette craving in smokers. We hypothesize that in smokers, pregabalin at 300 mg/day, will be more effective than placebo in decreasing smoking behavior and attenuating tobacco withdrawal and cigarette craving.
Condition | Intervention | Phase |
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Nicotine Dependence |
Drug: pregabalin Other: cigarettes |
Phase 0 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment |
Official Title: | GABA Medication for Tobacco |
Estimated Enrollment: | 40 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
pregabalin 300mg/day given in conjunction with smoking cigarettes.
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Drug: pregabalin
Help stop smoking
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2: Experimental
cigarettes with study medication
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Other: cigarettes
help stop smoking with study medication
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A total of 40 smokers will be randomly assigned to a sequence of treatment conditions: 300 mg/day pregabalin or placebo treatment. Each treatment condition will last 4 days, separated by 3 to 15 days of washout period.
Smokers will have twice daily outpatient visits during the first 3 days and a test session on day 4. In each treatment period, smokers will abstain from smoking for 2.5 days, starting at 10 pm on Day 1 until the test session on Day 4. During the test sessions, measures of smoking behavior and tobacco withdrawal will be obtained. Smoking is an important public health problem costing over 430,000 lives a year in this county alone. The first line-treatments, Nicotine Replacement Treatments (NRT) or bupropion, compared to placebo, approximately double the long-term success rate for smoking cessation. Given that there remains 46 million smokers in this country and over 70 percent of them interested in quitting smoking, development of new treatments for smoking cessation will have great public health implications. Currently we have screened 13 subjects with 10 completers. This study is currently recruiting human subjects.
Study is still active.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lance Barnes | 203-937-4823 | lance.barnes@yale.edu |
Contact: Stacy Minnix, B.S.W | 203-937-4805 | stacy.minnix@yale.edu |
United States, Connecticut | |
Yale University | Recruiting |
New Haven, Connecticut, United States, 06520 | |
Contact: Mehmet Sofuoglu, M.D., Ph.D. 203-937-4809 mehmet.sofuoglu@yale.edu | |
Contact: James Poling, Ph.D. 203-937-4830 james.poling@yale.edu |
Principal Investigator: | Mehmet Sofuoglu, M.D., Ph.D. | Yale University |
Responsible Party: | Yale University ( Mehmet Sofuoglu M.D., Ph.D. ) |
Study ID Numbers: | R01 DA020752, YALE 0701002184, VA 0023 |
Study First Received: | March 24, 2008 |
Last Updated: | March 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00644137 History of Changes |
Health Authority: | United States: Federal Government |
smoking sensations no cravings desire to smoke |
Smoking Neurotransmitter Agents Mental Disorders Tobacco Use Disorder Gamma-Aminobutyric Acid Substance-Related Disorders |
Pregabalin Disorders of Environmental Origin Peripheral Nervous System Agents Analgesics Anticonvulsants |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Tobacco Use Disorder Physiological Effects of Drugs Disorders of Environmental Origin Pregabalin Pharmacologic Actions Mental Disorders Sensory System Agents |
Therapeutic Uses Gamma-Aminobutyric Acid Substance-Related Disorders GABA Agents Peripheral Nervous System Agents Analgesics Central Nervous System Agents Anticonvulsants |