Bupropion and Weight Control for Smoking Cessation - 1

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Completed
• CT.gov ID: NCT00006170
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 349
• Location: 1
• Arms: 4
• Duration (Months): 120
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether the addition of bupropion (Zyban) to cognitive behavioral therapy (CBT) will enhance longer-term tobacco abstinence in women.

Condition or Disease	Intervention/Treatment	Phase
Tobacco Use Disorder	Drug: Bupropion; Drug: Placebo; Behavioral: weight concerns intervention; Behavioral: smoking cessation intervention	Phase 4

Detailed Description

Although rates of smoking have declined, the decrease in prevalence has been much less pronounced in women than in men, and women are particularly vulnerable to ongoing smoking-related morbidity and mortality. One important reason for gender differences in smoking cessation is concern about cessation-related weight gain among women, which is associated with poorer cessation outcome. We previously documented that cognitive behavior therapy to minimize weight concerns (CBT) was effective in promoting cessation and controlling weight gain among weight concerned women smokers. The current study is a randomized, double-blind, controlled trial to determine whether the addition of bupropion (Zyban) to CBT (12 sessions over 14 weeks, with 6 booster sessions) will enhance longer-term abstinence. Bupropion was the clear medication of choice for this trial because it is efficacious in promoting smoking cessation, attenuates cessation-related weight gain (particularly in women), and relieves negative mood, which appears more common in weight-concerned women. Four hundred fifty weight concerned women smokers will be randomized to either CBT for weight concerns plus standard cessation or standard smoking cessation only and six months of either bupropion (Zyban) or placebo (2 x 2 design). Primary outcome will be rates of smoking abstinence at 1 year and time to relapse across the four treatment conditions. In addition, we will determine the effects of these treatments on tobacco withdrawal, mood, and weight. Results of this investigation will provide information on the relative efficacy of the CBT intervention and bupropion alone and in combination and the utility of drug and counseling strategies that are specifically tailored for a high-risk population.

Study Design

• Study Type: Interventional
• Actual Enrollment: 349 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Bupropion and Weight Control for Smoking Cessation
• Study Start Date: Sep 1, 2000
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bupropion and Weight Concerns intervention Bupropion SR and a weight concerns psychosocial intervention	Drug: Bupropion; smoking cessation medication aid; Other Names: zyban ; Behavioral: weight concerns intervention; cognitive behavioral treatment to address weight concners
Active Comparator: Placebo and Weight Concerns A matched placebo administered on same schedule as bupriopion and a weight concerns psychosocial intervention for smoking cesstion	Drug: Placebo; A matched placebo pill; Behavioral: weight concerns intervention; cognitive behavioral treatment to address weight concners
Active Comparator: Bupropion and standard smoking cessation Bupropion SR and a time and attention controlled smoking cessation intervention	Drug: Bupropion; smoking cessation medication aid; Other Names: zyban ; Behavioral: smoking cessation intervention; Cognitive behavioral intervention for smoking cessation
Placebo Comparator: Placebo and standard smoking cessation A matched placebo administered on same schedule as bupriopion and a time and attention controlled smoking cessation intervention	Drug: Placebo; A matched placebo pill; Behavioral: smoking cessation intervention; Cognitive behavioral intervention for smoking cessation

Outcome Measures

Primary Outcome Measures

1. Smoking Abstinence [3 months]

   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.

2. Smoking Abstinence [6 months]

   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.

3. Smoking Abstinence [12 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Smoke at least 10 cigarettes per day

• Report concern about cessation-related weight gain

• Motivated to quit smoking

Exclusion Criteria:

• Currently pregnant, lactating, or no medically approved method of contraception

• Major medical problem

• History of seizure disorder or head injury

• Current or historical psychosis or bipolar disorder

• History of alcohol or substance abuse within previous year

• Current or historical eating disorder

• Use of antidepressant medication, monoamine oxidase inhibitor or lithium with previous month

• Multiple Drug Allergies

• Current major depressive disorder

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Western Psychiatric Institute & Clinic	Pittsburgh	Pennsylvania	United States	15213 2593

Sponsors and Collaborators

• University of Pittsburgh
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Marsha Marcus, Ph.D., Western Psychiatric Institute & Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marsha Marcus, Professor of Psychiatry, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT00006170
• Other Study ID Numbers: NIDA-04174-1; R01DA004174
• First Posted: Aug 10, 2000
• Last Update Posted: Jul 21, 2016
• Last Verified: Jun 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Marsha Marcus, Professor of Psychiatry, University of Pittsburgh: smoking cessation; Women; bupropion; weight concerns; weight
• Additional relevant MeSH terms: Tobacco Use Disorder; Bupropion

Study Results

Participant Flow

Recruitment Details	Women were recruited between September 1999 and October 2005.
Pre-assignment Detail	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.

Arm/Group Title	Weight Concerns + Bupropion (WC+B)	Weight Concerns + Placebo (WC+P)	Social Support + Bupropion (SS+B)	Social Support + Placebo (SS+P)
Arm/Group Description	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.	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.	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.	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.
Period Title: Overall Study
STARTED	106	87	89	67
COMPLETED	57	37	46	28
NOT COMPLETED	49	50	43	39

Baseline Characteristics

Arm/Group Title	WC+B	WC+P	SS+B	SS+P	Total
Arm/Group Description	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.	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.	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.	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 of all reporting groups
Overall Participants	106	87	89	67	349
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	106 100%	87 100%	89 100%	67 100%	349 100%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42.1 (9.2)	42.6 (10.0)	41.0 (11.2)	42.3 (10.4)	42.0 (10.1)
Sex: Female, Male (Count of Participants)
Female	106 100%	87 100%	89 100%	67 100%	349 100%
Male	0 0%	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	106 100%	87 100%	89 100%	67 100%	349 100%

Outcome Measures

1. Primary Outcome

Title	Smoking Abstinence
Description	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.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	WC+B	WC+P	SS+B	SS+P
Arm/Group Description
Measure Participants	70	39	56	37
Number [percentage of participants]	41 (1) 38.7%	18 20.7%	33 37.1%	19 28.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	WC+B, WC+P
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Regression, Logistic
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	WC+B, SS+B
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.
Statistical Test of Hypothesis	p-Value	0.25
	Comments
	Method	Regression, Logistic
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	SS+B, SS+P
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.
Statistical Test of Hypothesis	p-Value	0.07
	Comments
	Method	Regression, Logistic
	Comments

2. Primary Outcome

Title	Smoking Abstinence
Description	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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	WC+B	WC+P	SS+B	SS+P
Arm/Group Description
Measure Participants	64	40	47	32
Number [percentage of participants]	34 32.1%	11 12.6%	21 23.6%	10 14.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	WC+B, WC+P
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	WC+B, SS+B
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.
Statistical Test of Hypothesis	p-Value	0.053
	Comments
	Method	Regression, Logistic
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	SS+B, SS+P
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.
Statistical Test of Hypothesis	p-Value	0.08
	Comments
	Method	Regression, Logistic
	Comments

3. Primary Outcome

Title	Smoking Abstinence
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	WC+B	WC+P	SS+B	SS+P
Arm/Group Description
Measure Participants	57	37	46	28
Number [percentage of participants]	24 22.6%	8 9.2%	19 21.3%	7 10.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	WC+B, WC+P
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.
Statistical Test of Hypothesis	p-Value	0.006
	Comments
	Method	Regression, Logistic
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	WC+B, SS+B
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.
Statistical Test of Hypothesis	p-Value	0.45
	Comments
	Method	Regression, Logistic
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	SS+B, SS+P
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.
Statistical Test of Hypothesis	p-Value	0.046
	Comments
	Method	Regression, Logistic
	Comments

Adverse Events

Arm/Group Title	WC+B		WC+P		SS+B		SS+P
Arm/Group Description
All Cause Mortality
	WC+B		WC+P		SS+B		SS+P
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	WC+B		WC+P		SS+B		SS+P
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/106 (0%)		0/87 (0%)		0/89 (0%)		0/67 (0%)
Other (Not Including Serious) Adverse Events
	WC+B		WC+P		SS+B		SS+P
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/106 (0%)		0/87 (0%)		0/89 (0%)		0/67 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.