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Trial Outcomes & Findings for Bupropion and Weight Control for Smoking Cessation - 1 (NCT NCT00006170)

NCT ID: NCT00006170

Last Updated: 2016-07-21

Results Overview

Women were interviewed using the time-line follow-back method and expired-air carbon monoxide (CO) was collected using a Vitalograph BreathCO monitor. Salivary samples were collected immediately after each assessment visit (1, 3, 6, and 12 mo). A CO reading of 8ppm or less and cotinine level of \>15 micrograms/L were used to confirm non-smoking.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

349 participants

Primary outcome timeframe

3 months

Results posted on

2016-07-21

Participant Flow

Women were recruited between September 1999 and October 2005.

Potential participants were excluded for current MDD, suicidality, drug or alcohol dependence within the past year, psychotic disorders, conditions associated with lowered seizure threshold, use of medications contraindicated with bupropion, uncontrolled hypertension, recent use of bupropion, pregnancy or use of other smoking or weight treatments.

Participant milestones

Participant milestones
Measure
Weight Concerns + Bupropion (WC+B)
An approach was taken to combine cognitive behavioral therapy and pharmacotherapy to women who had weight concerns after cessation. This group took bupropion, a widely used, efficacious smoking cessation agent.
Weight Concerns + Placebo (WC+P)
An approach was taken to combine cognitive behavioral therapy and pharmacotherapy to women who had weight concerns after cessation. This group took a placebo instead of the bupropion.
Social Support + Bupropion (SS+B)
An approach was taken to combine standard cessation therapy with added discussion of smoking topics but no specific weight focus and pharmacotherapy. This group took bupropion, a widely used, efficacious smoking cessation agent.
Social Support + Placebo (SS+P)
An approach was taken to combine standard cessation therapy with added discussion of smoking topics but no specific weight focus and pharmacotherapy. This group took a placebo instead of the bupropion.
Overall Study
STARTED
106
87
89
67
Overall Study
COMPLETED
57
37
46
28
Overall Study
NOT COMPLETED
49
50
43
39

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bupropion and Weight Control for Smoking Cessation - 1

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
WC+B
n=106 Participants
An approach was taken to combine cognitive behavioral therapy and pharmacotherapy to women who had weight concerns after cessation. This group took bupropion, a widely used, efficacious smoking cessation agent.
WC+P
n=87 Participants
An approach was taken to combine cognitive behavioral therapy and pharmacotherapy to women who had weight concerns after cessation. This group took a placebo instead of bupropion.
SS+B
n=89 Participants
An approach was taken to combine standard cessation therapy with added discussion of smoking topics but no specific weight focus and pharmacotherapy. This group took bupropion, a widely used, efficacious smoking cessation agent.
SS+P
n=67 Participants
An approach was taken to combine standard cessation therapy with added discussion of smoking topics but no specific weight focus and pharmacotherapy. This group took a placebo instead of the bupropion.
Total
n=349 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
106 Participants
n=5 Participants
87 Participants
n=7 Participants
89 Participants
n=5 Participants
67 Participants
n=4 Participants
349 Participants
n=21 Participants
Age, Categorical
>=65 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, Continuous
42.1 years
STANDARD_DEVIATION 9.2 • n=5 Participants
42.6 years
STANDARD_DEVIATION 10.0 • n=7 Participants
41.0 years
STANDARD_DEVIATION 11.2 • n=5 Participants
42.3 years
STANDARD_DEVIATION 10.4 • n=4 Participants
42.0 years
STANDARD_DEVIATION 10.1 • n=21 Participants
Sex: Female, Male
Female
106 Participants
n=5 Participants
87 Participants
n=7 Participants
89 Participants
n=5 Participants
67 Participants
n=4 Participants
349 Participants
n=21 Participants
Sex: Female, Male
Male
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
Region of Enrollment
United States
106 participants
n=5 Participants
87 participants
n=7 Participants
89 participants
n=5 Participants
67 participants
n=4 Participants
349 participants
n=21 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Participants with available data at 3mo. All others were unable to provide data at this time point.

Women were interviewed using the time-line follow-back method and expired-air carbon monoxide (CO) was collected using a Vitalograph BreathCO monitor. Salivary samples were collected immediately after each assessment visit (1, 3, 6, and 12 mo). A CO reading of 8ppm or less and cotinine level of \>15 micrograms/L were used to confirm non-smoking.

Outcome measures

Outcome measures
Measure
WC+B
n=70 Participants
WC+P
n=39 Participants
SS+B
n=56 Participants
SS+P
n=37 Participants
Smoking Abstinence
41 percentage of participants
1
18 percentage of participants
33 percentage of participants
19 percentage of participants

PRIMARY outcome

Timeframe: 6 months

Population: Participants with available data at 6mo. All others were unable to provide data at this time point.

Women were interviewed using the time-line follow-back method and expired-air carbon monoxide (CO) was collected using a Vitalograph BreathCO monitor. Salivary samples were collected immediately after each assessment visit (1, 3, 6, and 12 mo). A CO reading of 8ppm or less and cotinine level of \>15 micrograms/L were used to confirm non-smoking.

Outcome measures

Outcome measures
Measure
WC+B
n=64 Participants
WC+P
n=40 Participants
SS+B
n=47 Participants
SS+P
n=32 Participants
Smoking Abstinence
34 percentage of participants
11 percentage of participants
21 percentage of participants
10 percentage of participants

PRIMARY outcome

Timeframe: 12 months

Population: Participants with available data at 12mo. All others were unable to provide data at this time point.

Women were interviewed using the time-line follow-back method and expired-air carbon monoxide (CO) was collected using a Vitalograph BreathCO monitor. Salivary samples were collected immediately after each assessment visit (1, 3, 6, and 12 mo). A CO reading of 8ppm or less and cotinine level of \>15 micrograms/L were used to confirm non-smoking.

Outcome measures

Outcome measures
Measure
WC+B
n=57 Participants
WC+P
n=37 Participants
SS+B
n=46 Participants
SS+P
n=28 Participants
Smoking Abstinence
24 percentage of participants
8 percentage of participants
19 percentage of participants
7 percentage of participants

Adverse Events

WC+B

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

WC+P

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

SS+B

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

SS+P

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. Michele Levine

University of Pittsburgh

Phone: 412-647-0703

Results disclosure agreements

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