Trial Outcomes & Findings for Gradual vs. Abrupt Cessation Treatment for Smoking (NCT NCT00297492)

NCT ID: NCT00297492

Last Updated: 2013-09-20

Results Overview

Number of participants with self-reported prolonged abstinence from cigarette smoking through 6 months of follow-up, verified by a breath carbon monoxide reading of less than 10 parts per million

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 750 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2013-09-20

Participant Flow

Participants were recruited using advertisements targeting smokers who wanted to quit smoking gradually. Advertisements were placed in newspapers in two cities in South Carolina and one city in New Mexico.

Enrolled sample size of 750; 4 were excluded because found to be ineligible after enrollment.

Participant milestones

Measure	Gradual Reduction Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date	Abrupt Cessation Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date	Minimal Intervention Minimal intervention to mimic intervention at a primary care office
Set Quit Date STARTED	297	299	150
Set Quit Date COMPLETED	290	286	145
Set Quit Date NOT COMPLETED	7	13	5
6 Month Follow-up STARTED	290	286	145
6 Month Follow-up COMPLETED	227	237	118
6 Month Follow-up NOT COMPLETED	63	49	27

Reasons for withdrawal

Measure	Gradual Reduction Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date	Abrupt Cessation Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date	Minimal Intervention Minimal intervention to mimic intervention at a primary care office
Set Quit Date Lost to Follow-up	7	13	5
6 Month Follow-up Lost to Follow-up	63	49	27

Baseline Characteristics

Gradual vs. Abrupt Cessation Treatment for Smoking

Baseline characteristics by cohort

Measure	Gradual Reduction n=297 Participants Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date	Abrupt Cessation n=299 Participants Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date	Minimal Intervention n=150 Participants Minimal intervention to mimic intervention at a primary care office	Total n=746 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	273 Participants n=5 Participants	276 Participants n=7 Participants	139 Participants n=5 Participants	688 Participants n=4 Participants
Age, Categorical >=65 years	24 Participants n=5 Participants	23 Participants n=7 Participants	11 Participants n=5 Participants	58 Participants n=4 Participants
Age Continuous	48 years STANDARD_DEVIATION 13 • n=5 Participants	48 years STANDARD_DEVIATION 12 • n=7 Participants	47 years STANDARD_DEVIATION 13 • n=5 Participants	48 years STANDARD_DEVIATION 13 • n=4 Participants
Sex: Female, Male Female	159 Participants n=5 Participants	165 Participants n=7 Participants	80 Participants n=5 Participants	404 Participants n=4 Participants
Sex: Female, Male Male	138 Participants n=5 Participants	134 Participants n=7 Participants	70 Participants n=5 Participants	342 Participants n=4 Participants
Region of Enrollment United States	297 participants n=5 Participants	299 participants n=7 Participants	150 participants n=5 Participants	746 participants n=4 Participants

PRIMARY outcome

Timeframe: 6 months

Population: This was an intent-to-treat analysis. Those who were lost to follow-up were assumed to not be abstinent from smoking at the time of the 6 month follow-up.

Number of participants with self-reported prolonged abstinence from cigarette smoking through 6 months of follow-up, verified by a breath carbon monoxide reading of less than 10 parts per million

Outcome measures

Measure	Gradual Reduction n=297 Participants Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date; nicotine lozenges were provided to aid reduction prior to the quit date and for use on and following the quit date.	Abrupt Cessation n=299 Participants Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date; nicotine lozenges were provided for use starting on the quit date.	Minimal Intervention n=150 Participants Minimal intervention to mimic intervention at a primary care office; nicotine lozenges were provided for use starting on the quit date.
Number of Participants With Prolonged Abstinence Through 6 Months Verified by Carbon Monoxide Measurement	12 participants	20 participants	7 participants

Adverse Events

Gradual Reduction

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Abrupt Cessation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Minimal Intervention

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

Dr. John Hughes

University of Vermont

Phone: 802-656-9610

Email: John.Hughes@uvm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place