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Sponsors and Collaborators: |
Yale University VA Connecticut Healthcare System |
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Information provided by: | Yale University |
ClinicalTrials.gov Identifier: | NCT00633256 |
A total of 20 subjects will participate in this four week, between groups, double-blind, placebo controlled study. Subjects will participate in two experimental sessions separated by approximately one week. Subjects will be randomized to receive either 50 mg cycloserine or placebo combined with cue exposure. Several physiological and subjective outcome measures (e.g., heart rate, blood pressure, galvanic skin response) will be obtained during the sessions. Experimental sessions will last approximately 4.5 hours with follow-up sessions lasting approximately thirty minutes. Our aims are:
4) To examine the safety and tolerability of cycloserine treatment in smokers. We hypothesize that cycloserine will be well tolerated by smokers.
Condition | Intervention |
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Smoking |
Drug: Cycloserine Drug: Placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Factorial Assignment, Efficacy Study |
Official Title: | The Effect of Cycloserine on Smoking Behavior in Nicotine Dependent Smokers. |
Enrollment: | 20 |
Study Start Date: | December 2006 |
Study Completion Date: | February 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Cycloserine: Experimental
50 mg cycloserine
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Drug: Cycloserine
50 mg Cycloserine given in two separate experimental sessions separated by approximately one week.
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Placebo: Sham Comparator
Matched placebo
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Drug: Placebo
Matched placebo for subjects randomized to placebo arm. Given in two experimental sessions separated by approximately one week.
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Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Connecticut | |
West Haven VA | |
West Haven, Connecticut, United States, 06516 |
Principal Investigator: | James Poling, Ph.D. | Yale University |
Responsible Party: | Yale University ( James Poling, Ph.D. / Research Scientist ) |
Study ID Numbers: | 0601001031 |
Study First Received: | February 29, 2008 |
Last Updated: | March 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00633256 History of Changes |
Health Authority: | United States: Institutional Review Board |
Antimetabolites Nicotine polacrilex Cycloserine Anti-Bacterial Agents Anti-Infective Agents Smoking |
Neostigmine Nicotine Anti-Infective Agents, Urinary Antitubercular Agents Isoniazid |
Cycloserine Antimetabolites Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Anti-Infective Agents, Urinary Renal Agents Pharmacologic Actions |
Antibiotics, Antitubercular Smoking Habits Anti-Bacterial Agents Therapeutic Uses Antitubercular Agents |