Trial Outcomes & Findings for Counseling and Nicotine Replacement Therapy in Helping Adult Smokers Quit Smoking (NCT NCT00365508)

NCT ID: NCT00365508

Last Updated: 2016-03-29

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 642 participants
• Primary outcome timeframe: 6-months
• Results posted on: 2016-03-29

Participant Flow

Participants were recruited through ads/physician referral at: FCCC, Geisinger Medical Center, Hematology Oncology Associates of Central NY, Howard University, LSU, Main Line Health System, Medical College of GA, Meharry Medical College, Mount Sinai Medical Center (Miami), North Shore University, SUNY Downstate Medical Center, and Virtua Health.

1299 individuals were screened for this trial over 4 years; 454 individuals were ineligible, 194 refused enrollment, and 651 were randomized. Nine individuals either withdrew from the study prior to treatment or were found to be ineligible after randomization and were removed from the intent-to-treat sample. The final ITT sample was 642 (321/arm).

Participant milestones

Measure	Nicotine Patch Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.	Nicotine Lozenge Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).
Overall Study STARTED	321	321
Overall Study COMPLETED	182	167
Overall Study NOT COMPLETED	139	154

Reasons for withdrawal

Measure	Nicotine Patch Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.	Nicotine Lozenge Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).
Overall Study Lost to Follow-up	139	154

Baseline Characteristics

Counseling and Nicotine Replacement Therapy in Helping Adult Smokers Quit Smoking

Baseline characteristics by cohort

Measure	Arm I n=321 Participants Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.	Arm II n=321 Participants Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).	Total n=642 Participants Total of all reporting groups
Age, Continuous	44.7 years STANDARD_DEVIATION 12.7 • n=5 Participants	44.8 years STANDARD_DEVIATION 11.9 • n=7 Participants	44.7 years STANDARD_DEVIATION 12.3 • n=5 Participants
Sex: Female, Male Female	195 Participants n=5 Participants	170 Participants n=7 Participants	365 Participants n=5 Participants
Sex: Female, Male Male	126 Participants n=5 Participants	151 Participants n=7 Participants	277 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6-months

Population: Intent to treat analysis (lost to follow-up = smoker)

Outcome measures

Measure	Arm I n=321 Participants Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.	Arm II n=321 Participants Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).
24-hour Point Prevalence Abstinence at the 6-month Follow up	50 participants	35 participants

SECONDARY outcome

Timeframe: 2 weeks

Population: Intent to treat

Applied to use of the intervention (number of lozenges/day or number of patches used per week) not considering abstinence

Outcome measures

Measure	Arm I n=321 Participants Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.	Arm II n=321 Participants Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).
Rate of Compliance During the First 2 Weeks	231 participants	87 participants

Adverse Events

Arm I

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm II

Serious events: 7 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm I n=321 participants at risk Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.	Arm II n=321 participants at risk Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).
Cardiac disorders Stroke	0.62% 2/321 • Number of events 2 • 6 months Administered a checklist of side effects from NRT and collected any additional information on adverse events.	0.00% 0/321 • 6 months Administered a checklist of side effects from NRT and collected any additional information on adverse events.
Nervous system disorders Seizure	0.31% 1/321 • Number of events 1 • 6 months Administered a checklist of side effects from NRT and collected any additional information on adverse events.	0.31% 1/321 • Number of events 1 • 6 months Administered a checklist of side effects from NRT and collected any additional information on adverse events.
Injury, poisoning and procedural complications killed in car accident	0.31% 1/321 • Number of events 1 • 6 months Administered a checklist of side effects from NRT and collected any additional information on adverse events.	0.00% 0/321 • 6 months Administered a checklist of side effects from NRT and collected any additional information on adverse events.
Cardiac disorders Heart disease	0.00% 0/321 • 6 months Administered a checklist of side effects from NRT and collected any additional information on adverse events.	0.31% 1/321 • Number of events 1 • 6 months Administered a checklist of side effects from NRT and collected any additional information on adverse events.
Gastrointestinal disorders ulcer	0.00% 0/321 • 6 months Administered a checklist of side effects from NRT and collected any additional information on adverse events.	0.31% 1/321 • Number of events 1 • 6 months Administered a checklist of side effects from NRT and collected any additional information on adverse events.
Gastrointestinal disorders appendicitis	0.00% 0/321 • 6 months Administered a checklist of side effects from NRT and collected any additional information on adverse events.	0.31% 1/321 • Number of events 1 • 6 months Administered a checklist of side effects from NRT and collected any additional information on adverse events.
Cardiac disorders heart attack	0.00% 0/321 • 6 months Administered a checklist of side effects from NRT and collected any additional information on adverse events.	0.31% 1/321 • Number of events 1 • 6 months Administered a checklist of side effects from NRT and collected any additional information on adverse events.
Respiratory, thoracic and mediastinal disorders cough	0.00% 0/321 • 6 months Administered a checklist of side effects from NRT and collected any additional information on adverse events.	0.31% 1/321 • Number of events 1 • 6 months Administered a checklist of side effects from NRT and collected any additional information on adverse events.
Surgical and medical procedures Abcessed tooth	0.00% 0/321 • 6 months Administered a checklist of side effects from NRT and collected any additional information on adverse events.	0.31% 1/321 • Number of events 1 • 6 months Administered a checklist of side effects from NRT and collected any additional information on adverse events.

Other adverse events

Adverse event data not reported

Additional Information

Robert Schnoll

University of Pennsylvania

Phone: 215-746-7143

Email: schnoll@mail.med.upenn.edu

Results disclosure agreements

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