Trial Outcomes & Findings for Tailored Smoking Cessation Treatment for LIVE FOR LIFE® Participants (NCT NCT01560507)

Results Overview

Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

19 participants

Primary outcome timeframe

End of study drug treatment period (11-12 weeks)

Results posted on

2014-12-24

Participant Flow

Subjects were recruited from May 2012 until May 2013. We were only able to enter 19 of the 300 subjects into the study. We discontinued the study in July 2013 because of the recruitment difficulties.

Of the 19 subjects who signed a consent form: 9 subjects began study participation; 7 subjects were excluded prior to receiving study drug because of medical issues and 3 subjects met other exclusion criteria and were excluded prior to receiving study drug.

Participant milestones

Participant milestones
Measure	Varenicline (Chantix) This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received varenicline.	Nicotine Patches This group consists of smokers who, based on smoking behavior, respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They continued to use only nicotine patches.	Bupropion (Zyban) and Nicotine Patches This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received bupropion and nicotine patches.
Overall Study STARTED	5	2	2
Overall Study COMPLETED	1	0	0
Overall Study NOT COMPLETED	4	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Varenicline (Chantix) This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received varenicline.	Nicotine Patches This group consists of smokers who, based on smoking behavior, respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They continued to use only nicotine patches.	Bupropion (Zyban) and Nicotine Patches This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received bupropion and nicotine patches.
Overall Study Lost to Follow-up	3	1	2
Overall Study Withdrawal by Subject	1	1	0

Baseline Characteristics

Tailored Smoking Cessation Treatment for LIVE FOR LIFE® Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Varenicline (Chantix) n=5 Participants This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received varenicline.	Nicotine Patches n=2 Participants This group consists of smokers who, based on smoking behavior, respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They continued to use only nicotine patches.	Bupropion (Zyban) and Nicotine Patches n=2 Participants This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received bupropion and nicotine patches.	Total n=9 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	5 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	9 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	47.02 years STANDARD_DEVIATION 10.75 • n=5 Participants	33.47 years STANDARD_DEVIATION 0.43 • n=7 Participants	39.61 years STANDARD_DEVIATION 3.94 • n=5 Participants	42.36 years STANDARD_DEVIATION 9.75 • n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Region of Enrollment United States	5 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants	9 participants n=4 Participants

PRIMARY outcome

Timeframe: End of study drug treatment period (11-12 weeks)

Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: After 6 month Follow-Up

Population: Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.

Study was terminated early due to difficulties with enrollment. No outcome measures were assessed."

Outcome measures

Outcome data not reported

Adverse Events

Varenicline (Chantix)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nicotine Patches

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bupropion (Zyban) and Nicotine Patches

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. Jed Rose

Duke University Medical Center

Phone: 919-668-5055

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place