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
| 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
| 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
| 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 monthsPopulation: Mean follow up was 7.3 months
Conservative vs. aggressive smoking strategies in treating smoking cessation.
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
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place