The Effect of Cycloserine on Smoking Behavior in Nicotine Dependent Smokers

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00633256
• Other study ID #: 0601001031
• Status: Completed
• Phase: N/A
• First received: February 29, 2008
• Last updated: March 14, 2012
• Start date: December 2006
• Est. completion date: February 2008

Study information

• Verified date: March 2012
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking

Intervention

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

Locations

Country	Name	City	State
United States	West Haven VA	West Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	VA Connecticut Healthcare System

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cigarettes Smoked Per Day	The number of cigarettes smoked per day at the 1 week follow up time point.	1 week follow-up	No
Secondary	Cigarettes Smoked Per Day	The number of cigarettes smoked per day at the 4-week follow up timepoint.	4 Week Followup	No
Secondary	Urinary Cotinine Level	Urinary Cotinine level at the 4-week follow up timepoint	4 Week Follow-up Timepoint	No