The Effect of Cycloserine on Smoking Behavior in Nicotine Dependent Smokers

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.

Study Overview

• Status: Completed
• Conditions: Smoking
• Intervention / Treatment: Drug: Cycloserine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • West Haven, Connecticut, United States, 06516
      • West Haven VA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cigarettes Smoked Per Day	The number of cigarettes smoked per day at the 1 week follow up time point.	1 week follow-up

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: VA Connecticut Healthcare System
• Investigators: Principal Investigator: James Poling, Ph.D., Yale University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: February 29, 2008
• First Submitted That Met QC Criteria: March 10, 2008
• First Posted (Estimate): March 11, 2008

Study Record Updates

• Last Update Posted (Estimate): April 11, 2012
• Last Update Submitted That Met QC Criteria: March 14, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antimetabolites; Hypolipidemic Agents; Lipid Regulating Agents; Anti-Bacterial Agents; Antitubercular Agents; Antibiotics, Antitubercular; Anti-Infective Agents, Urinary; Renal Agents; Fatty Acid Synthesis Inhibitors; Cycloserine; Isoniazid
• Other Study ID Numbers: 0601001031