Trial Outcomes & Findings for Maintaining Nonsmoking: Older Smokers - 1 (NCT NCT00086385)
NCT ID: NCT00086385
Last Updated: 2015-03-23
Results Overview
Primary outcome variable was 7-day point prevalence cigarette abstinence verified biochemically at week 104
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
403 participants
Primary outcome timeframe
Two years
Results posted on
2015-03-23
Participant Flow
Subjects will be men and women, 50 years and older who smoke at least 10 cigarettes a day. They will respond to requests in the public media for individuals who are interested in quitting smoking, and will be referred from sources like UCSF Ambulatory Care Clinics, California Pacific General Medical Practice, and Jewish Family and Community Center.
One participant died at week 5 before randomization.
Participant milestones
| Measure |
Brief Treatment
Pharmacological Treatment - Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement treatment
Brief Counseling - The counseling intervention consist of five 90-minute group meetings.
No further treatment during Weeks 12-52.
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.
|
Extended NRT
Pharmacological Treatment - Following completion of the Brief Treatment, subjects assigned to this condition will continue receiving NRT for up to 52 weeks. Subjects in this condition will be encouraged to continue NRT through Week 24. If a subject who terminates NRT and resumes smoking, before Week 50, will be instructed to set a quite date and resume NRT.
Counseling Treatment - This is identical to the Brief Counseling described above.
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.
|
Extended Tailored Counseling + NRT
Tailored Counseling Treatment- The primary goal of the extended treatment is to prevent relapse. Secondary goal is to encourage initiation of abstinence for those who have no attained it by Week 12, and re-initiation of abstinence after slips. Subjects will participate in the Brief Treatment followed by individual sessions. The first extended treatment counseling session will occur at Week 10. Additional sessions will be held every two weeks then every four weeks, and finally at Weeks 44 and 52. Each session will be 20-30 minutes long. Between sessions subjects will be contacted by phone for brief check-ins (5-10 minutes).
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.
|
Tailored/No Extended NRT
This condition is identical to the Tailored/NRT condition except that no NRT is available after completion of the Brief Treatment.
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
100
|
99
|
104
|
99
|
|
Overall Study
COMPLETED
|
98
|
97
|
103
|
98
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
1
|
1
|
Reasons for withdrawal
| Measure |
Brief Treatment
Pharmacological Treatment - Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement treatment
Brief Counseling - The counseling intervention consist of five 90-minute group meetings.
No further treatment during Weeks 12-52.
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.
|
Extended NRT
Pharmacological Treatment - Following completion of the Brief Treatment, subjects assigned to this condition will continue receiving NRT for up to 52 weeks. Subjects in this condition will be encouraged to continue NRT through Week 24. If a subject who terminates NRT and resumes smoking, before Week 50, will be instructed to set a quite date and resume NRT.
Counseling Treatment - This is identical to the Brief Counseling described above.
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.
|
Extended Tailored Counseling + NRT
Tailored Counseling Treatment- The primary goal of the extended treatment is to prevent relapse. Secondary goal is to encourage initiation of abstinence for those who have no attained it by Week 12, and re-initiation of abstinence after slips. Subjects will participate in the Brief Treatment followed by individual sessions. The first extended treatment counseling session will occur at Week 10. Additional sessions will be held every two weeks then every four weeks, and finally at Weeks 44 and 52. Each session will be 20-30 minutes long. Between sessions subjects will be contacted by phone for brief check-ins (5-10 minutes).
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.
|
Tailored/No Extended NRT
This condition is identical to the Tailored/NRT condition except that no NRT is available after completion of the Brief Treatment.
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.
|
|---|---|---|---|---|
|
Overall Study
Death
|
2
|
2
|
1
|
1
|
Baseline Characteristics
Maintaining Nonsmoking: Older Smokers - 1
Baseline characteristics by cohort
| Measure |
Brief Treatment
n=100 Participants
Pharmacological Treatment - Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement treatment
Brief Counseling - The counseling intervention consist of five 90-minute group meetings.
No further treatment during Weeks 12-52.
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.
|
Extended NRT
n=99 Participants
Pharmacological Treatment - Following completion of the Brief Treatment, subjects assigned to this condition will continue receiving NRT for up to 52 weeks. Subjects in this condition will be encouraged to continue NRT through Week 24. If a subject who terminates NRT and resumes smoking, before Week 50, will be instructed to set a quite date and resume NRT.
Counseling Treatment - This is identical to the Brief Counseling described above.
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.
|
Extended Tailored Counseling + NRT
n=104 Participants
Tailored Counseling Treatment- The primary goal of the extended treatment is to prevent relapse. Secondary goal is to encourage initiation of abstinence for those who have no attained it by Week 12, and re-initiation of abstinence after slips. Subjects will participate in the Brief Treatment followed by individual sessions. The first extended treatment counseling session will occur at Week 10. Additional sessions will be held every two weeks then every four weeks, and finally at Weeks 44 and 52. Each session will be 20-30 minutes long. Between sessions subjects will be contacted by phone for brief check-ins (5-10 minutes).
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.
|
Tailored/No Extended NRT
n=99 Participants
This condition is identical to the Tailored/NRT condition except that no NRT is available after completion of the Brief Treatment.
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.
|
Total
n=402 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
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
93 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
85 Participants
n=4 Participants
|
358 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
|
Age, Continuous
|
56.190 years
STANDARD_DEVIATION 5.40 • n=5 Participants
|
56.97 years
STANDARD_DEVIATION 5.46 • n=7 Participants
|
56.88 years
STANDARD_DEVIATION 6.82 • n=5 Participants
|
56.63 years
STANDARD_DEVIATION 5.64 • n=4 Participants
|
56.67 years
STANDARD_DEVIATION 5.85 • n=21 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
161 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
241 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
100 participants
n=5 Participants
|
99 participants
n=7 Participants
|
104 participants
n=5 Participants
|
99 participants
n=4 Participants
|
402 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Two yearsPrimary outcome variable was 7-day point prevalence cigarette abstinence verified biochemically at week 104
Outcome measures
| Measure |
Brief Treatment
n=100 Participants
Pharmacological Treatment - Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement treatment
Brief Counseling - The counseling intervention consist of five 90-minute group meetings.
No further treatment during Weeks 12-52.
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.
|
Extended NRT
n=99 Participants
Pharmacological Treatment - Following completion of the Brief Treatment, subjects assigned to this condition will continue receiving NRT for up to 52 weeks. Subjects in this condition will be encouraged to continue NRT through Week 24. If a subject who terminates NRT and resumes smoking, before Week 50, will be instructed to set a quite date and resume NRT.
Counseling Treatment - This is identical to the Brief Counseling described above.
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.
|
Extended Tailored Counseling + NRT
n=104 Participants
Tailored Counseling Treatment- The primary goal of the extended treatment is to prevent relapse. Secondary goal is to encourage initiation of abstinence for those who have no attained it by Week 12, and re-initiation of abstinence after slips. Subjects will participate in the Brief Treatment followed by individual sessions. The first extended treatment counseling session will occur at Week 10. Additional sessions will be held every two weeks then every four weeks, and finally at Weeks 44 and 52. Each session will be 20-30 minutes long. Between sessions subjects will be contacted by phone for brief check-ins (5-10 minutes).
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.
|
Tailored/No Extended NRT
n=99 Participants
This condition is identical to the Tailored/NRT condition except that no NRT is available after completion of the Brief Treatment.
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.
|
|---|---|---|---|---|
|
Participants Abstinent From Cigarettes
|
31 participants
5.4
|
35 participants
6.82
|
39 participants
5.64
|
45 participants
5.46
|
Adverse Events
Brief Treatment
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Extended NRT
Serious events: 5 serious events
Other events: 3 other events
Deaths: 0 deaths
Extended Tailored Counseling + NRT
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
Tailored/No Extended NRT
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Brief Treatment
n=100 participants at risk
Pharmacological Treatment - Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement treatment
Brief Counseling - The counseling intervention consist of five 90-minute group meetings.
No further treatment during Weeks 12-52.
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.
|
Extended NRT
n=99 participants at risk
Pharmacological Treatment - Following completion of the Brief Treatment, subjects assigned to this condition will continue receiving NRT for up to 52 weeks. Subjects in this condition will be encouraged to continue NRT through Week 24. If a subject who terminates NRT and resumes smoking, before Week 50, will be instructed to set a quite date and resume NRT.
Counseling Treatment - This is identical to the Brief Counseling described above.
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.
|
Extended Tailored Counseling + NRT
n=104 participants at risk
Tailored Counseling Treatment- The primary goal of the extended treatment is to prevent relapse. Secondary goal is to encourage initiation of abstinence for those who have no attained it by Week 12, and re-initiation of abstinence after slips. Subjects will participate in the Brief Treatment followed by individual sessions. The first extended treatment counseling session will occur at Week 10. Additional sessions will be held every two weeks then every four weeks, and finally at Weeks 44 and 52. Each session will be 20-30 minutes long. Between sessions subjects will be contacted by phone for brief check-ins (5-10 minutes).
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.
|
Tailored/No Extended NRT
n=99 participants at risk
This condition is identical to the Tailored/NRT condition except that no NRT is available after completion of the Brief Treatment.
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.
|
|---|---|---|---|---|
|
General disorders
Death (not related to study)
|
2.0%
2/100 • Number of events 2 • Baseline to week 104.
|
2.0%
2/99 • Number of events 2 • Baseline to week 104.
|
0.96%
1/104 • Number of events 1 • Baseline to week 104.
|
1.0%
1/99 • Number of events 1 • Baseline to week 104.
|
|
Congenital, familial and genetic disorders
Angina
|
0.00%
0/100 • Baseline to week 104.
|
1.0%
1/99 • Number of events 1 • Baseline to week 104.
|
0.00%
0/104 • Baseline to week 104.
|
0.00%
0/99 • Baseline to week 104.
|
|
Congenital, familial and genetic disorders
Heart Procedure
|
0.00%
0/100 • Baseline to week 104.
|
1.0%
1/99 • Number of events 1 • Baseline to week 104.
|
0.00%
0/104 • Baseline to week 104.
|
0.00%
0/99 • Baseline to week 104.
|
|
Congenital, familial and genetic disorders
Implantation of an Automatic Implantable Cardioverter Defibrillator
|
0.00%
0/100 • Baseline to week 104.
|
1.0%
1/99 • Number of events 1 • Baseline to week 104.
|
0.00%
0/104 • Baseline to week 104.
|
0.00%
0/99 • Baseline to week 104.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma Attack
|
0.00%
0/100 • Baseline to week 104.
|
0.00%
0/99 • Baseline to week 104.
|
0.96%
1/104 • Number of events 1 • Baseline to week 104.
|
0.00%
0/99 • Baseline to week 104.
|
|
Cardiac disorders
Myocardial Infarct (MI)
|
0.00%
0/100 • Baseline to week 104.
|
0.00%
0/99 • Baseline to week 104.
|
0.96%
1/104 • Number of events 1 • Baseline to week 104.
|
0.00%
0/99 • Baseline to week 104.
|
|
General disorders
Fatigue, Weakness, and Unsteady Walking
|
0.00%
0/100 • Baseline to week 104.
|
0.00%
0/99 • Baseline to week 104.
|
0.00%
0/104 • Baseline to week 104.
|
1.0%
1/99 • Number of events 1 • Baseline to week 104.
|
|
Infections and infestations
Infection
|
0.00%
0/100 • Baseline to week 104.
|
0.00%
0/99 • Baseline to week 104.
|
0.96%
1/104 • Number of events 1 • Baseline to week 104.
|
0.00%
0/99 • Baseline to week 104.
|
Other adverse events
| Measure |
Brief Treatment
n=100 participants at risk
Pharmacological Treatment - Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement treatment
Brief Counseling - The counseling intervention consist of five 90-minute group meetings.
No further treatment during Weeks 12-52.
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.
|
Extended NRT
n=99 participants at risk
Pharmacological Treatment - Following completion of the Brief Treatment, subjects assigned to this condition will continue receiving NRT for up to 52 weeks. Subjects in this condition will be encouraged to continue NRT through Week 24. If a subject who terminates NRT and resumes smoking, before Week 50, will be instructed to set a quite date and resume NRT.
Counseling Treatment - This is identical to the Brief Counseling described above.
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.
|
Extended Tailored Counseling + NRT
n=104 participants at risk
Tailored Counseling Treatment- The primary goal of the extended treatment is to prevent relapse. Secondary goal is to encourage initiation of abstinence for those who have no attained it by Week 12, and re-initiation of abstinence after slips. Subjects will participate in the Brief Treatment followed by individual sessions. The first extended treatment counseling session will occur at Week 10. Additional sessions will be held every two weeks then every four weeks, and finally at Weeks 44 and 52. Each session will be 20-30 minutes long. Between sessions subjects will be contacted by phone for brief check-ins (5-10 minutes).
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.
|
Tailored/No Extended NRT
n=99 participants at risk
This condition is identical to the Tailored/NRT condition except that no NRT is available after completion of the Brief Treatment.
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Lung Biopsy
|
0.00%
0/100 • Baseline to week 104.
|
0.00%
0/99 • Baseline to week 104.
|
0.96%
1/104 • Number of events 1 • Baseline to week 104.
|
0.00%
0/99 • Baseline to week 104.
|
|
General disorders
Midsternal Pressure
|
0.00%
0/100 • Baseline to week 104.
|
0.00%
0/99 • Baseline to week 104.
|
0.96%
1/104 • Number of events 1 • Baseline to week 104.
|
0.00%
0/99 • Baseline to week 104.
|
|
Psychiatric disorders
Anxiety, High Blood Presure
|
0.00%
0/100 • Baseline to week 104.
|
0.00%
0/99 • Baseline to week 104.
|
0.00%
0/104 • Baseline to week 104.
|
1.0%
1/99 • Number of events 1 • Baseline to week 104.
|
|
General disorders
Dental Issues
|
1.0%
1/100 • Number of events 1 • Baseline to week 104.
|
1.0%
1/99 • Number of events 1 • Baseline to week 104.
|
0.96%
1/104 • Number of events 1 • Baseline to week 104.
|
0.00%
0/99 • Baseline to week 104.
|
|
General disorders
Insomnia
|
0.00%
0/100 • Baseline to week 104.
|
1.0%
1/99 • Number of events 2 • Baseline to week 104.
|
0.96%
1/104 • Number of events 1 • Baseline to week 104.
|
2.0%
2/99 • Number of events 2 • Baseline to week 104.
|
|
Nervous system disorders
Numbness/Tingling
|
0.00%
0/100 • Baseline to week 104.
|
1.0%
1/99 • Number of events 1 • Baseline to week 104.
|
0.00%
0/104 • Baseline to week 104.
|
0.00%
0/99 • Baseline to week 104.
|
Additional Information
Sharon M. Hall, PhD
University of California, San Francisco
Phone: 415-476-7574
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place