Tobacco Use DisorderPhase 4NCT00006170
Bupropion and Weight Control for Smoking Cessation - 1
A Phase 4 study testing Bupropion, weight concerns intervention and smoking cessation intervention in people with Tobacco Use Disorder, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Bupropion, weight concerns intervention and smoking cessation intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 349 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2000to Sep 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Smoke at least 10 cigarettes per day
- Report concern about cessation-related weight gain
- Motivated to quit smoking
Who cannot join
- 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
Show all 9Show fewer
- Use of antidepressant medication, monoamine oxidase inhibitor or lithium with previous month
- Multiple Drug Allergies
- Current major depressive disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Psychiatric Institute & Clinic
Pittsburgh, Pennsylvania, 15213 2593
About this study
Official title: Bupropion and Weight Control for Smoking Cessation
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.
Read the 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.
- Conditions
- Tobacco Use Disorder
- Being tested
- Bupropion, Placebo, weight concerns intervention, smoking cessation intervention
- Keywords
- smoking cessation, Women, bupropion, weight concerns, weight
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupropionDrug
Also called zyban
smoking cessation medication aid
PlaceboDrug
A matched placebo pill
weight concerns interventionBehavioural
cognitive behavioral treatment to address weight concners
smoking cessation interventionBehavioural
Cognitive behavioral intervention for smoking cessation
| Study group | Role | What they receive |
|---|---|---|
| Bupropion and Weight Concerns intervention | Experimental | Bupropion SR and a weight concerns psychosocial intervention Receives: Drug: Bupropion; Behavioral: weight concerns intervention |
| Placebo and Weight Concerns | Active comparator | A matched placebo administered on same schedule as bupriopion and a weight concerns psychosocial intervention for smoking cesstion Receives: Drug: Placebo; Behavioral: weight concerns intervention |
| Bupropion and standard smoking cessation | Active comparator | Bupropion SR and a time and attention controlled smoking cessation intervention Receives: Drug: Bupropion; Behavioral: smoking cessation intervention |
| Placebo and standard smoking cessation | Placebo comparator | A matched placebo administered on same schedule as bupriopion and a time and attention controlled smoking cessation intervention Receives: Drug: Placebo; Behavioral: smoking cessation intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Abstinence
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.
Measured: 3 months
Smoking Abstinence
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.
Measured: 6 months
Smoking Abstinence
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2000 (estimated)
- Study startSep 2000
- Primary completionDec 2009
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 349 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Marsha Marcus, University of Pittsburgh
- Investigators
- Marsha Marcus, Ph.D., Principal investigator, Western Psychiatric Institute & Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006170
- Sponsor's protocol ID
- NIDA-04174-1
- Other IDs
- R01DA004174
- Status last verified
- Jun 2016
- First submitted
- 9 Aug 2000
- Last updated
- 21 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Levine MD, Perkins KA, Kalarchian MA, Cheng Y, Houck PR, Slane JD, Marcus MD. Bupropion and cognitive behavioral therapy for weight-concerned women smokers. Arch Intern Med. 2010 Mar 22;170(6):543-50. doi: 10.1001/archinternmed.2010.33.
PubMed 20308641Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.
PubMed 37230961
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bupropion and Weight Control for Smoking Cessation
- ClinicalTrials.gov ID
- NCT00006170
- Acronym / sponsor ID
- NIDA-04174-1
- Conditions
- Tobacco Use Disorder
- Keywords
- smoking cessation, Women, bupropion, weight concerns, weight
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 349 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2000
- Primary completion
- Dec 2009 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 10 Aug 2000 (estimated)
- Results
- Posted 14 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bupropion and Weight Concerns intervention | Experimental | Drug: Bupropion, Behavioral: weight concerns interventionBupropion SR and a weight concerns psychosocial intervention |
| Placebo and Weight Concerns | Active comparator | Drug: Placebo, Behavioral: weight concerns interventionA matched placebo administered on same schedule as bupriopion and a weight concerns psychosocial intervention for smoking cesstion |
| Bupropion and standard smoking cessation | Active comparator | Drug: Bupropion, Behavioral: smoking cessation interventionBupropion SR and a time and attention controlled smoking cessation intervention |
| Placebo and standard smoking cessation | Placebo comparator | Drug: Placebo, Behavioral: smoking cessation interventionA matched placebo administered on same schedule as bupriopion and a time and attention controlled smoking cessation intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Smoke at least 10 cigarettes per day
- Report concern about cessation-related weight gain
- Motivated to quit smoking
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BupropionAlso: zybansmoking cessation medication aid | Drug | Bupropion and Weight Concerns intervention, Bupropion and standard smoking cessation |
| PlaceboA matched placebo pill | Drug | Placebo and Weight Concerns, Placebo and standard smoking cessation |
| weight concerns interventioncognitive behavioral treatment to address weight concners | Behavioural | Bupropion and Weight Concerns intervention, Placebo and Weight Concerns |
| smoking cessation interventionCognitive behavioral intervention for smoking cessation | Behavioural | Bupropion and standard smoking cessation, Placebo and standard smoking cessation |
Primary outcome
Smoking Abstinence
Time frame: 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.
Smoking Abstinence
Time frame: 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.
Smoking Abstinence
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20308641Levine MD, Perkins KA, Kalarchian MA, Cheng Y, Houck PR, Slane JD, Marcus MD. Bupropion and cognitive behavioral therapy for weight-concerned women smokers. Arch Intern Med. 2010 Mar 22;170(6):543-50. doi: 10.1001/archinternmed.2010.33.
- Derived from this study: PubMed 37230961Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.
- Individual participant dataSharing planned: No
Related trials for Tobacco Use Disorder
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marsha Marcus, Ph.D. principal investigator
Western Psychiatric Institute & Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupropion, weight concerns intervention and smoking cessation intervention in people with Tobacco Use Disorder, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking Abstinence (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00006170, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2016.