Trial Outcomes & Findings for The Effect of Cycloserine on Smoking Behavior in Nicotine Dependent Smokers (NCT NCT00633256)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

1 week follow-up

Results posted on

2012-04-11

Participant Flow

Participant milestones

Participant milestones
Measure	Cycloserine 50 mg cycloserine	Placebo Matched placebo
Overall Study STARTED	12	13
Overall Study COMPLETED	8	10
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Cycloserine on Smoking Behavior in Nicotine Dependent Smokers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cycloserine n=12 Participants 50 mg cycloserine	Placebo n=13 Participants Matched placebo	Total n=25 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	41.1 years STANDARD_DEVIATION 6.2 • n=5 Participants	41.5 years STANDARD_DEVIATION 11.5 • n=7 Participants	41.3 years STANDARD_DEVIATION 9.1 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	13 participants n=7 Participants	25 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 week follow-up

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

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

Outcome measures

Outcome measures
Measure	Cycloserine n=8 Participants 50 mg cycloserine	Placebo n=8 Participants Matched placebo
Cigarettes Smoked Per Day	10.3 Cigarettes per day Standard Deviation 6.3	13.9 Cigarettes per day Standard Deviation 12.7

SECONDARY outcome

Timeframe: 4 Week Followup

Population: The number of subjects in the study at the 4-week timepoint.

The number of cigarettes smoked per day at the 4-week follow up timepoint.

Outcome measures

Outcome measures
Measure	Cycloserine n=8 Participants 50 mg cycloserine	Placebo n=8 Participants Matched placebo
Cigarettes Smoked Per Day	9.9 Cigarettes per day Standard Deviation 7.7	11.0 Cigarettes per day Standard Deviation 9.2

SECONDARY outcome

Timeframe: 4 Week Follow-up Timepoint

Population: Subjects used for analysis are those who reached the 4 week followup timepoint.

Urinary Cotinine level at the 4-week follow up timepoint

Outcome measures

Outcome measures
Measure	Cycloserine n=8 Participants 50 mg cycloserine	Placebo n=8 Participants Matched placebo
Urinary Cotinine Level	1645.5 Mean ng/ml Standard Deviation 1180.8	2062.6 Mean ng/ml Standard Deviation 1091.1

Adverse Events

Cycloserine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

James Poling, Ph.D.

Yale University

Phone: 203-937-4830

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place