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| Sponsor: | Yale University |
|---|---|
| Collaborator: |
VA Connecticut Healthcare System |
| Information provided by: | Yale University |
| ClinicalTrials.gov Identifier: | NCT00633256 |
Purpose
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:
To examine the effect of cycloserine vs. placebo on extinction of smoking cue reactivity in overnight abstinent smokers. Reactivity to smoking cues will be captured with self-report smoking urges and physiological measures (heart rate, blood pressure, and skin conductance).
We hypothesize that cycloserine, relative to placebo, will facilitate extinction of smoking cue reactivity.
4) To examine the safety and tolerability of cycloserine treatment in smokers. We hypothesize that cycloserine will be well tolerated by smokers.
| Condition | Intervention |
|---|---|
|
Smoking |
Drug: Cycloserine Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
|---|---|
|
Experimental: Cycloserine
50 mg cycloserine
|
Drug: Cycloserine
50 mg Cycloserine given in two separate experimental sessions separated by approximately one week.
Other Names:
|
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Sham Comparator: Placebo
Matched placebo
|
Drug: Placebo
Matched placebo for subjects randomized to placebo arm. Given in two experimental sessions separated by approximately one week.
Other Name: Placebo
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Connecticut | |
| West Haven VA | |
| West Haven, Connecticut, United States, 06516 | |
| Principal Investigator: | James Poling, Ph.D. | Yale University |
More Information
| Responsible Party: | James Poling, Ph.D. / Research Scientist, Yale University |
| ClinicalTrials.gov Identifier: | NCT00633256 History of Changes |
| Other Study ID Numbers: | 0601001031 |
| Study First Received: | February 29, 2008 |
| Last Updated: | March 10, 2008 |
| Health Authority: | United States: Institutional Review Board |
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Smoking Habits Cycloserine Nicotine Anti-Infective Agents, Urinary Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Renal Agents Antibiotics, Antitubercular Anti-Bacterial Agents |
Antitubercular Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents |