SmokingNCT00633256

The Effect of Cycloserine on Smoking Behavior in Nicotine Dependent Smokers

A study testing Cycloserine in people with Smoking, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Smoking
What is being tested?: Cycloserine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Dec 2006to Feb 2008
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

West Haven VA
West Haven, Connecticut, 06516

Other trials in United States

About this study

Official title: 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:

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.
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.
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.
To examine the safety and tolerability of cycloserine treatment in smokers. We hypothesize that cycloserine will be well tolerated by smokers.

Conditions: Smoking
Being tested: Cycloserine, Placebo
Medical subject headings: Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CycloserineDrug
Also called Closina Aspen, Austral., Cycloserine Capsules USP 29, Cycloserine (TM)King, UK, D-cycloserin IFET (IFET), Gr.
50 mg Cycloserine given in two separate experimental sessions separated by approximately one week.
PlaceboDrug
Matched placebo for subjects randomized to placebo arm. Given in two experimental sessions separated by approximately one week.

Study groups in NCT00633256
Study group	Role	What they receive
Cycloserine	Experimental	50 mg cycloserine Receives: Drug: Cycloserine
Placebo	Sham comparator	Matched placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Cigarettes Smoked Per Day
The number of cigarettes smoked per day at the 1 week follow up time point.
Measured: 1 week follow-up

Secondary outcomes (2)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2006Feb 2008

First posted11 Mar 2008 (estimated)
Study startDec 2006
Primary completionFeb 2008
Study completionFeb 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SmokingStudies of the same condition, open and under way.
More trials run by Yale UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00633256
Sponsor's protocol ID: 0601001031
Status last verified: Mar 2012
First submitted: 29 Feb 2008
Last updated: 11 Apr 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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.
PubMed 19592176

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Cycloserine on Smoking Behavior in Nicotine Dependent Smokers.
ClinicalTrials.gov ID: NCT00633256
Acronym / sponsor ID: 0601001031
Conditions: Smoking
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: VA Connecticut Healthcare System
Study start: Dec 2006
Primary completion: Feb 2008 (actual)
Study completion: Feb 2008 (actual)
First posted: 11 Mar 2008 (estimated)
Results: Posted 11 Apr 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.
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.
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.
To examine the safety and tolerability of cycloserine treatment in smokers. We hypothesize that cycloserine will be well tolerated by smokers.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Cycloserine	Experimental	Drug: Cycloserine50 mg cycloserine
Placebo	Sham comparator	Drug: PlaceboMatched placebo

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (7 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CycloserineAlso: Closina Aspen, Austral., Cycloserine Capsules USP 29, Cycloserine (TM)King, UK, D-cycloserin IFET (IFET), Gr.50 mg Cycloserine given in two separate experimental sessions separated by approximately one week.	Drug	Cycloserine
PlaceboMatched placebo for subjects randomized to placebo arm. Given in two experimental sessions separated by approximately one week.	Drug	Placebo

Primary outcome

Cigarettes Smoked Per Day
Time frame: 1 week follow-up
The number of cigarettes smoked per day at the 1 week follow up time point.

2 secondary outcomes

Cigarettes Smoked Per Day
Time frame: 4 Week Followup
Urinary Cotinine Level
Time frame: 4 Week Follow-up Timepoint

Results and safety

Results posted to the registry on 11 Apr 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cycloserine	12	8
Placebo	13	10

Primary outcome: Cigarettes Smoked Per Day

Time frame: 1 week follow-up. Mean (Standard Deviation). Unit: Cigarettes per day

Measure	Cycloserine n = 8	Placebo n = 8
Value	10.3 (6.3)	13.9 (12.7)

Population analysed: The number of participants used for analysis were those who completed the 4-week follow-up timepoint.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cycloserine	0 of 12 (0%)	0 of 12 (0%)	Not reported
Placebo	0 of 13 (0%)	0 of 13 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19592176Santa 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

James Poling, Ph.D. principal investigator

Yale University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Cycloserine in people with Smoking, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cigarettes Smoked Per Day (time frame: 1 week follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00633256, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2012.