The Effect of Cycloserine on Smoking Behavior in Nicotine Dependent Smokers

NCT ID: NCT00633256

Last Updated: 2012-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2008-02-29

Brief 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.

Conditions

Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Cycloserine

50 mg cycloserine

Group Type: EXPERIMENTAL

Cycloserine

Intervention Type: DRUG

50 mg Cycloserine given in two separate experimental sessions separated by approximately one week.

Placebo

Matched placebo

Group Type: SHAM_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Cycloserine

50 mg Cycloserine given in two separate experimental sessions separated by approximately one week.

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention 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

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Connecticut Healthcare System

FED

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

James Poling

Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James Poling, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

West Haven VA

West Haven, Connecticut, United States

Countries

United States

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.

Reference Type: BACKGROUND

PMID: 19592176 (View on PubMed)

Other Identifiers

0601001031

Identifier Type: -

Identifier Source: org_study_id