The Effect of Cycloserine on Smoking Behavior in Nicotine Dependent Smokers

Overview

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.

Full Title of Study: “The Effect of Cycloserine on Smoking Behavior in Nicotine Dependent Smokers.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: February 2008

Interventions

  • Drug: Cycloserine
    • 50 mg Cycloserine given in two separate experimental sessions separated by approximately one week.
  • Drug: Placebo
    • Matched placebo for subjects randomized to placebo arm. Given in two experimental sessions separated by approximately one week.

Arms, Groups and Cohorts

  • Experimental: Cycloserine
    • 50 mg cycloserine
  • Sham Comparator: Placebo
    • Matched placebo

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Cigarettes Smoked Per Day
    • Time Frame: 4 Week Followup
    • The number of cigarettes smoked per day at the 4-week follow up timepoint.
  • Urinary Cotinine Level
    • Time Frame: 4 Week Follow-up Timepoint
    • Urinary Cotinine level at the 4-week follow up timepoint

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Yale University
  • Collaborator
    • VA Connecticut Healthcare System
  • Provider of Information About this Clinical Study
    • Principal Investigator: James Poling, Research Scientist – Yale University
  • Overall Official(s)
    • James Poling, Ph.D., Principal Investigator, Yale University

References

Santa Ana EJ, Rounsaville BJ, Frankforter TL, Nich C, Babuscio T, Poling J, Gonsai K, Hill KP, Carroll KM. D-Cycloserine attenuates reactivity to smoking cues in nicotine dependent smokers: a pilot investigation. Drug Alcohol Depend. 2009 Oct 1;104(3):220-7. doi: 10.1016/j.drugalcdep.2009.04.023. Epub 2009 Jul 9.

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