Trial Outcomes & Findings for Comparing Smoking Treatment Programs for Lighter Smokers - 1 (NCT NCT00086411)
NCT ID: NCT00086411
Last Updated: 2019-08-06
Results Overview
Completion of Treatment and Smoking Cessation by Two Different Types of Medications and Counseling Types at 12, 26, and 52 Weeks Post-treatment Initiation. The counseling types were Medication Management (MM) and Mayo counseling models. MM counseling was a 4 session lower intensity counseling model and Mayo counseling was a 10 session higher intensity model. A twofold definition of treatment completion included both medication and counseling session adherence. Treatment completion was defined as consistently taking the active medication as prescribed (80%) of the time during the medication period and attending at least 7 of the 10 required High C sessions or 3 of the 4 Low C sessions. Participants had to meet both requirements to be designated as full treatment completers. Seven-day point prevalence abstinence was the primary measure of abstinence at follow-up Weeks 12, 24, and 52. Abstinence was confirmed by biochemical testing.
COMPLETED
PHASE2
260 participants
52 weeks
2019-08-06
Participant Flow
The sample consists of 260 self-referred lighter smokers to an urban university setting. The first participant was enrolled in February 2005, and the last follow-up was completed in March 2008. A total of 302 met confirmatory screening criteria, and 260 were enrolled.
An in-person confirmatory screening interview consisted of a medical examination, structured psychological interview (Mini International Neuropsychiatric Interview; Sheenan et al., 1997), and biochemical testing (i.e., carbon monoxide reading of expired air \[CO\], blood alcohol concentration,and urine drug test).
Participant milestones
| Measure |
1 Bup+MM
bupropion and MM with placebo patch
|
2 Bup+Mayo
bupropion and Mayo counseling with placebo patch.
|
3 Patch+MM
patch and MM with placebo pills
|
4 Patch+Mayo
patch and Mayo counseling with placebo patch
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
70
|
63
|
62
|
65
|
|
Overall Study
COMPLETED
|
59
|
52
|
49
|
53
|
|
Overall Study
NOT COMPLETED
|
11
|
11
|
13
|
12
|
Reasons for withdrawal
| Measure |
1 Bup+MM
bupropion and MM with placebo patch
|
2 Bup+Mayo
bupropion and Mayo counseling with placebo patch.
|
3 Patch+MM
patch and MM with placebo pills
|
4 Patch+Mayo
patch and Mayo counseling with placebo patch
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
11
|
13
|
12
|
Baseline Characteristics
Comparing Smoking Treatment Programs for Lighter Smokers - 1
Baseline characteristics by cohort
| Measure |
1: Bup+MM
n=70 Participants
bupropion and MM with placebo patch
|
2 Bup+Mayo
n=63 Participants
bupropion and Mayo counseling with placebo patch.
|
3 Patch+MM
n=62 Participants
patch and MM with placebo pills
|
4 Patch+Mayo
n=65 Participants
patch and Mayo counseling with placebo patch
|
Total
n=260 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
43.3 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
42.4 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
45.8 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
43.1 years
STANDARD_DEVIATION 11.3 • n=4 Participants
|
43.3 years
STANDARD_DEVIATION 12.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
148 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
112 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
70 participants
n=5 Participants
|
63 participants
n=7 Participants
|
62 participants
n=5 Participants
|
65 participants
n=4 Participants
|
260 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 52 weeksCompletion of Treatment and Smoking Cessation by Two Different Types of Medications and Counseling Types at 12, 26, and 52 Weeks Post-treatment Initiation. The counseling types were Medication Management (MM) and Mayo counseling models. MM counseling was a 4 session lower intensity counseling model and Mayo counseling was a 10 session higher intensity model. A twofold definition of treatment completion included both medication and counseling session adherence. Treatment completion was defined as consistently taking the active medication as prescribed (80%) of the time during the medication period and attending at least 7 of the 10 required High C sessions or 3 of the 4 Low C sessions. Participants had to meet both requirements to be designated as full treatment completers. Seven-day point prevalence abstinence was the primary measure of abstinence at follow-up Weeks 12, 24, and 52. Abstinence was confirmed by biochemical testing.
Outcome measures
| Measure |
1: Bup+MM
n=70 Participants
bupropion and MM with placebo patch
|
2 Bup+Mayo
n=63 Participants
bupropion and Mayo counseling with placebo patch.
|
3 Patch+mm
n=62 Participants
patch and MM with placebo pills
|
4 Patch+Mayo
n=65 Participants
patch and Mayo counseling with placebo patch
|
|---|---|---|---|---|
|
Percent Treatment Sessions Attended
|
77.9 Percentage of attended tx. sessions
Standard Error .05
|
85.9 Percentage of attended tx. sessions
Standard Error .04
|
66.8 Percentage of attended tx. sessions
Standard Error .06
|
66.6 Percentage of attended tx. sessions
Standard Error .06
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: PI is no longer with institution. All efforts have been exhausted to locate this data, but no data is available to be reported
Outcome measures
Outcome data not reported
Adverse Events
1: Bup+MM
2 Bup+Mayo
3 Patch+mm
4 Patch+Mayo
Serious adverse events
| Measure |
1: Bup+MM
n=70 participants at risk
bupropion and MM with placebo patch
|
2 Bup+Mayo
n=63 participants at risk
bupropion and Mayo counseling with placebo patch.
|
3 Patch+mm
n=62 participants at risk
patch and MM with placebo pills
|
4 Patch+Mayo
n=65 participants at risk
patch and Mayo counseling with placebo patch
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death
|
1.4%
1/70 • The reported time frame for study related serious adverse events was 1 year. Two participants died prior to the week 52 follow-up of non-study related problems. The reported time frame for adverse events is the first 12 weeks (3 weeks post medication).
|
0.00%
0/63 • The reported time frame for study related serious adverse events was 1 year. Two participants died prior to the week 52 follow-up of non-study related problems. The reported time frame for adverse events is the first 12 weeks (3 weeks post medication).
|
0.00%
0/62 • The reported time frame for study related serious adverse events was 1 year. Two participants died prior to the week 52 follow-up of non-study related problems. The reported time frame for adverse events is the first 12 weeks (3 weeks post medication).
|
0.00%
0/65 • The reported time frame for study related serious adverse events was 1 year. Two participants died prior to the week 52 follow-up of non-study related problems. The reported time frame for adverse events is the first 12 weeks (3 weeks post medication).
|
|
General disorders
Death
|
0.00%
0/70 • The reported time frame for study related serious adverse events was 1 year. Two participants died prior to the week 52 follow-up of non-study related problems. The reported time frame for adverse events is the first 12 weeks (3 weeks post medication).
|
0.00%
0/63 • The reported time frame for study related serious adverse events was 1 year. Two participants died prior to the week 52 follow-up of non-study related problems. The reported time frame for adverse events is the first 12 weeks (3 weeks post medication).
|
1.6%
1/62 • The reported time frame for study related serious adverse events was 1 year. Two participants died prior to the week 52 follow-up of non-study related problems. The reported time frame for adverse events is the first 12 weeks (3 weeks post medication).
|
0.00%
0/65 • The reported time frame for study related serious adverse events was 1 year. Two participants died prior to the week 52 follow-up of non-study related problems. The reported time frame for adverse events is the first 12 weeks (3 weeks post medication).
|
Other adverse events
| Measure |
1: Bup+MM
n=70 participants at risk
bupropion and MM with placebo patch
|
2 Bup+Mayo
n=63 participants at risk
bupropion and Mayo counseling with placebo patch.
|
3 Patch+mm
n=62 participants at risk
patch and MM with placebo pills
|
4 Patch+Mayo
n=65 participants at risk
patch and Mayo counseling with placebo patch
|
|---|---|---|---|---|
|
General disorders
Medication stopped due to reported side effects.
|
1.4%
1/70 • Number of events 1 • The reported time frame for study related serious adverse events was 1 year. Two participants died prior to the week 52 follow-up of non-study related problems. The reported time frame for adverse events is the first 12 weeks (3 weeks post medication).
|
4.8%
3/63 • Number of events 3 • The reported time frame for study related serious adverse events was 1 year. Two participants died prior to the week 52 follow-up of non-study related problems. The reported time frame for adverse events is the first 12 weeks (3 weeks post medication).
|
0.00%
0/62 • The reported time frame for study related serious adverse events was 1 year. Two participants died prior to the week 52 follow-up of non-study related problems. The reported time frame for adverse events is the first 12 weeks (3 weeks post medication).
|
3.1%
2/65 • Number of events 2 • The reported time frame for study related serious adverse events was 1 year. Two participants died prior to the week 52 follow-up of non-study related problems. The reported time frame for adverse events is the first 12 weeks (3 weeks post medication).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place