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The Effect of Cycloserine on Smoking Behavior in Nicotine Dependent Smokers

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ClinicalTrials.gov Identifier: NCT00633256
Recruitment Status : Completed
First Posted : March 11, 2008
Results First Posted : April 11, 2012
Last Update Posted : April 11, 2012
Sponsor:
Collaborator:
VA Connecticut Healthcare System
Information provided by (Responsible Party):
James Poling, Yale University

Study Description
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Brief Summary:

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:

  1. 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.

  2. To examine the effect of cycloserine vs. placebo when combined with two 4.5 hour laboratory cue exposure training sessions, on smoking behavior in smokers. Smoking behavior will be measured with self-report smoking and saliva cotinine levels.
  3. To examine the effect of cycloserine vs. placebo on memory performance in nicotine dependent smokers. Memory performance will be measured with verbal learning, recognition and recall tasks.

4) To examine the safety and tolerability of cycloserine treatment in smokers. We hypothesize that cycloserine will be well tolerated by smokers.


Condition or disease Intervention/treatment Phase
Smoking Drug: Cycloserine Drug: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Cycloserine on Smoking Behavior in Nicotine Dependent Smokers.
Study Start Date : December 2006
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking
Drug Information available for: Cycloserine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cycloserine
50 mg cycloserine
 Drug: Cycloserine
50 mg Cycloserine given in two separate experimental sessions separated by approximately one week.
Other Names:
  • Closina Aspen, Austral.
  • Cycloserine Capsules USP 29
  • Cycloserine (TM)King, UK
  • D-cycloserin IFET (IFET), Gr.
  • Proserine Hawon, Thai.
  • Seromycin - 250 MG - Capsule Dura Pharmaceuticals
  • Seromycin - 250 MG - Oral Capsule Eli Lilly
  • Seromycin (FM) Lilly, Canad.
  • Seromycin Dura, USA
  • Seromycin Lilly, Hong Kong
  • Seromycin With Isoniazid - 250 MG - Capsule Eli Lilly
  • Siklocap
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.


Outcome Measures
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Primary Outcome Measures :
  1. Cigarettes Smoked Per Day [ Time Frame: 1 week follow-up ]
    The number of cigarettes smoked per day at the 1 week follow up time point.


Secondary Outcome Measures :
  1. Cigarettes Smoked Per Day [ Time Frame: 4 Week Followup ]
    The number of cigarettes smoked per day at the 4-week follow up timepoint.

  2. Urinary Cotinine Level [ Time Frame: 4 Week Follow-up Timepoint ]
    Urinary Cotinine level at the 4-week follow up timepoint


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • female and male smokers, aged 18 to 55 years;
  • history of smoking daily for the past 12 months, at least 10 cigarettes daily;
  • CO level > 10ppm;
  • for women: not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods other than OCP;
  • Non-treatment seeking nicotine dependent smokers.

Exclusion Criteria:

  • history of heart disease, renal or hepatic diseases or other medical conditions that the physician investigator deems as contraindicated for the patient 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 other than nicotine;
  • regular use of any other tobacco products than cigarettes, including smokeless tobacco and nicotine products;
  • allergy to cycloserine;
  • subjects with epilepsy or a history of seizures;
  • Treatment seeking nicotine dependent smokers.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00633256


Locations
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United States, Connecticut
West Haven VA
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
VA Connecticut Healthcare System
Investigators
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Principal Investigator: James Poling, Ph.D. Yale University
More Information
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Publications:

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Responsible Party: James Poling, Research Scientist, Yale University
ClinicalTrials.gov Identifier: NCT00633256    
Other Study ID Numbers: 0601001031
First Posted: March 11, 2008    Key Record Dates
Results First Posted: April 11, 2012
Last Update Posted: April 11, 2012
Last Verified: March 2012
Additional relevant MeSH terms:
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Isoniazid
Cycloserine
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Anti-Infective Agents, Urinary
Renal Agents
Antibiotics, Antitubercular