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Completed

NCT Number: NCT00633256

The Effect of Cycloserine on Smoking Behavior in Nicotine Dependent Smokers

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.

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Key information

Conditions

Smoking Behavior

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West Haven VA

West Haven, Connecticut, 06516, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cycloserine

Drug

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

Placebo

Drug

Matched placebo for subjects randomized to placebo arm. Given in two experimental sessions separated by approximately one week.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • VA Connecticut Healthcare System

Registry information

Official study title

The Effect of Cycloserine on Smoking Behavior in Nicotine Dependent Smokers.

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Mar 11, 2008
Registry last updated
Apr 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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