The Effect of Cycloserine on Smoking Behavior in Nicotine Dependent Smokers

NCT00633256 | Completed Results DMC

• 1 other identifier: 0601001031
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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. 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).
2. 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. 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.

Conditions

Smoking

Outcome Measures

Primary Outcomes (1)

• Cigarettes Smoked Per Day

  The number of cigarettes smoked per day at the 1 week follow up time point.

  1 week follow-up

Secondary Outcomes (2)

• Cigarettes Smoked Per Day

  4 Week Followup

• Urinary Cotinine Level

  4 Week Follow-up Timepoint

Study Arms (2)

Cycloserine

EXPERIMENTAL

50 mg cycloserine

Drug: Cycloserine

Placebo

SHAM COMPARATOR

Matched placebo

Drug: Placebo

Interventions

Cycloserine DRUG

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

Also known as: 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

Cycloserine

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• VA Connecticut Healthcare System: collaborator

Study Sites (1)

West Haven VA

West Haven, Connecticut, 06516, United States

Location

Related 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.

  PMID: 19592176 BACKGROUND

MeSH Terms

Conditions

Smoking

Interventions

Cycloserine; Tacrine; Isoniazid

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins; Aminoacridines; Acridines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Hydrazines; Organic Chemicals; Isonicotinic Acids; Acids, Heterocyclic; Pyridines

Results Point of Contact

• Title: James Poling, Ph.D.
• Organization: Yale University

james.poling@yale.edu

203-937-4830

Study Officials

• James Poling, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: February 29, 2008
• First Posted: March 11, 2008
• Study Start: December 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: April 11, 2012
• Results First Posted: April 11, 2012

Record last verified: 2012-03

Locations

US (1)