The Effect of Cycloserine on Smoking Behavior in Nicotine Dependent Smokers

This study has been completed.
Sponsor:
Collaborator:
VA Connecticut Healthcare System
Information provided by (Responsible Party):
James Poling, Yale University
ClinicalTrials.gov Identifier:
NCT00633256
First received: February 29, 2008
Last updated: March 14, 2012
Last verified: March 2012
  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:

  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 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.

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Cigarettes Smoked Per Day [ Time Frame: 1 week follow-up ] [ Designated as safety issue: No ]
    The number of cigarettes smoked per day at the 1 week follow up time point.


Secondary Outcome Measures:
  • Cigarettes Smoked Per Day [ Time Frame: 4 Week Followup ] [ Designated as safety issue: No ]
    The number of cigarettes smoked per day at the 4-week follow up timepoint.

  • Urinary Cotinine Level [ Time Frame: 4 Week Follow-up Timepoint ] [ Designated as safety issue: No ]
    Urinary Cotinine level at the 4-week follow up timepoint


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:
  • 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.
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00633256

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

Publications:
Responsible Party: James Poling, Research Scientist, Yale University
ClinicalTrials.gov Identifier: NCT00633256     History of Changes
Other Study ID Numbers: 0601001031
Study First Received: February 29, 2008
Results First Received: March 14, 2012
Last Updated: March 14, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on August 18, 2014