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The Effect of Cycloserine on Smoking Behavior in Nicotine Dependent Smokers

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ClinicalTrials.gov Identifier: NCT00633256
Recruitment Status : Completed
First Posted : March 11, 2008
Results First Posted : April 11, 2012
Last Update Posted : April 11, 2012
Sponsor:
Collaborator:
VA Connecticut Healthcare System
Information provided by (Responsible Party):
James Poling, Yale University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Smoking
Interventions Drug: Cycloserine
Drug: Placebo
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cycloserine Placebo
Hide Arm/Group Description 50 mg cycloserine Matched placebo
Period Title: Overall Study
Started 12 13
Completed 8 10
Not Completed 4 3
Arm/Group Title Cycloserine Placebo Total
Hide Arm/Group Description 50 mg cycloserine Matched placebo Total of all reporting groups
Overall Number of Baseline Participants 12 13 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 13 participants 25 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
 100.0%
13
 100.0%
25
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 13 participants 25 participants
41.1  (6.2) 41.5  (11.5) 41.3  (9.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 13 participants 25 participants
Female
6
  50.0%
7
  53.8%
13
  52.0%
Male
6
  50.0%
6
  46.2%
12
  48.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 13 participants 25 participants
12 13 25
1.Primary Outcome
Title Cigarettes Smoked Per Day
Hide Description The number of cigarettes smoked per day at the 1 week follow up time point.
Time Frame 1 week follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants used for analysis were those who completed the 4-week follow-up timepoint.
Arm/Group Title Cycloserine Placebo
Hide Arm/Group Description:
50 mg cycloserine
Matched placebo
Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: Cigarettes per day
10.3  (6.3) 13.9  (12.7)
2.Secondary Outcome
Title Cigarettes Smoked Per Day
Hide Description The number of cigarettes smoked per day at the 4-week follow up timepoint.
Time Frame 4 Week Followup
Hide Outcome Measure Data
Hide Analysis Population Description
The number of subjects in the study at the 4-week timepoint.
Arm/Group Title Cycloserine Placebo
Hide Arm/Group Description:
50 mg cycloserine
Matched placebo
Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: Cigarettes per day
9.9  (7.7) 11.0  (9.2)
3.Secondary Outcome
Title Urinary Cotinine Level
Hide Description Urinary Cotinine level at the 4-week follow up timepoint
Time Frame 4 Week Follow-up Timepoint
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects used for analysis are those who reached the 4 week followup timepoint.
Arm/Group Title Cycloserine Placebo
Hide Arm/Group Description:
50 mg cycloserine
Matched placebo
Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: Mean ng/ml
1645.5  (1180.8) 2062.6  (1091.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cycloserine Placebo
Hide Arm/Group Description 50 mg cycloserine Matched placebo
All-Cause Mortality
Cycloserine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cycloserine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/13 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cycloserine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/13 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: James Poling, Ph.D.
Organization: Yale University
Phone: 203-937-4830
Responsible Party: James Poling, Yale University
ClinicalTrials.gov Identifier: NCT00633256     History of Changes
Other Study ID Numbers: 0601001031
First Submitted: February 29, 2008
First Posted: March 11, 2008
Results First Submitted: March 14, 2012
Results First Posted: April 11, 2012
Last Update Posted: April 11, 2012