Trial Outcomes & Findings for Comparison of Conservative and Aggressive Smoking Cessation Treatment Strategies in a Vascular Surgery Office Practice (NCT NCT01850589)

NCT ID: NCT01850589

Last Updated: 2015-08-03

Results Overview

Conservative vs. aggressive smoking strategies in treating smoking cessation.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

44 participants

Primary outcome timeframe

12 months

Results posted on

2015-08-03

Participant Flow

Participant milestones

Participant milestones
Measure
Conserative Therapy
Patients will be counseled by the vascular attending/fellow during their office appointment to stop smoking. Counseling will consist of a self-help materials including "Smart Move: A Stop Smoking Guide" from the American Cancer Society and a brief educational discussion on the benefits of smoking cessation. Patients randomized to Group 1 will be offered adjunctive treatment with nicotine replacement therapy at no cost.
Aggressive Therapy
8 week comprehensive smoking cessation and pharmacotherapy program consisting of: * 8 one hour group counseling sessions focusing on patient education and behavior modification. * Behavior modifications include cue recognition; coping skills; stress management; and relapse prevention skills. * Counseling includes information on nutrition, exercise, and chemical dependency. All counseling sessions will be held at 256C Mason Avenue. Pharmacotherapy adjuncts offered at no cost are as follows: * Chantix (varenicline) GlaxoSmithKline, * Zyban (bupropion) Pfizer * Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline.
Overall Study
STARTED
22
22
Overall Study
COMPLETED
14
22
Overall Study
NOT COMPLETED
8
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Conserative Therapy
Patients will be counseled by the vascular attending/fellow during their office appointment to stop smoking. Counseling will consist of a self-help materials including "Smart Move: A Stop Smoking Guide" from the American Cancer Society and a brief educational discussion on the benefits of smoking cessation. Patients randomized to Group 1 will be offered adjunctive treatment with nicotine replacement therapy at no cost.
Aggressive Therapy
8 week comprehensive smoking cessation and pharmacotherapy program consisting of: * 8 one hour group counseling sessions focusing on patient education and behavior modification. * Behavior modifications include cue recognition; coping skills; stress management; and relapse prevention skills. * Counseling includes information on nutrition, exercise, and chemical dependency. All counseling sessions will be held at 256C Mason Avenue. Pharmacotherapy adjuncts offered at no cost are as follows: * Chantix (varenicline) GlaxoSmithKline, * Zyban (bupropion) Pfizer * Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline.
Overall Study
Withdrawal by Subject
8
0

Baseline Characteristics

Comparison of Conservative and Aggressive Smoking Cessation Treatment Strategies in a Vascular Surgery Office Practice

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Conserative Therapy
n=14 Participants
Patients counseled by the vascular attending/fellow during office appointment to stop smoking. Counseling consists of self-help materials including "Smart Move: A Stop Smoking Guide" from the American Cancer Society and a brief educational discussion on the benefits of smoking cessation. Patients randomized to Group 1 will be offered adjunctive treatment with nicotine replacement therapy at no cost.
Aggressive Therapy
n=22 Participants
8 week comprehensive smoking cessation and pharmacotherapy program consisting of: * One hour group counseling sessions, focusing on patient education and behavior modification. * Behavior modifications including recognition; coping skills; stress management; and relapse prevention skills. * Counseling including information on nutrition, exercise, and chemical dependency. Counseling sessions will be held 256C Mason Avenue. Pharmacotherapy adjuncts offered at no cost are as follows: Chantix (varenicline) GlaxoSmithKline, Zyban (bupropion) Pfizer,and Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline. Varenicline, Bupropion,and nicotine nasal spray, inhaler, transdermal patches and gum: Pharmacotherapy adjuncts offered at no cost are as follows: * Chantix (varenicline) GlaxoSmithKline, * Zyban (bupropion) Pfizer,and Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline.
Total
n=36 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age, Categorical
Between 18 and 65 years
14 Participants
n=99 Participants
22 Participants
n=107 Participants
36 Participants
n=206 Participants
Age, Categorical
>=65 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Sex/Gender, Customized
Unspecified Gender
14 Participants
n=99 Participants
22 Participants
n=107 Participants
36 Participants
n=206 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Mean follow up was 7.3 months

Conservative vs. aggressive smoking strategies in treating smoking cessation.

Outcome measures

Outcome measures
Measure
Conserative Therapy
n=14 Participants
Patients counseled by the vascular attending/fellow during office appointment to stop smoking. Counseling consists of self-help materials including "Smart Move: A Stop Smoking Guide" from the American Cancer Society and a brief educational discussion on the benefits of smoking cessation. Patients randomized to Group 1 will be offered adjunctive treatment with nicotine replacement therapy at no cost.
Aggressive Therapy
n=22 Participants
8 week comprehensive smoking cessation and pharmacotherapy program consisting of: * One hour group counseling sessions, focusing on patient education and behavior modification. * Behavior modifications including recognition; coping skills; stress management; and relapse prevention skills. * Counseling including information on nutrition, exercise, and chemical dependency. Counseling sessions will be held 256C Mason Avenue. Pharmacotherapy adjuncts offered at no cost are as follows: Chantix (varenicline) GlaxoSmithKline, Zyban (bupropion) Pfizer,and Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline. Varenicline, Bupropion,and nicotine nasal spray, inhaler, transdermal patches and gum: Pharmacotherapy adjuncts offered at no cost are as follows: * Chantix (varenicline) GlaxoSmithKline, * Zyban (bupropion) Pfizer,and Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline.
Number of Participants With Smoking Cessation at 12 Months
4 Participants
10 Participants

Adverse Events

Conserative Therapy

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Aggressive Therapy

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. Jonathan Deitch, PI, Director of Vascular Surgery

Staten Island University Hospital

Phone: 718-226-9000

Results disclosure agreements

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