Tobacco DependencePhase 4NCT01621022
Bupropion Alone or Combined With Nicotine Gum
A Phase 4 study testing bupropion + nicotine gum in people with Tobacco Dependence, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
Focus of this study was to determine if bupropion was more effective for smoking cessation when used alone or combined with nicotine gum. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Dependence
- What is being tested?
- bupropion + nicotine gum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 608 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2001to Oct 2002
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Smoke 10 or more cigarettes per day
- Motivated to quit
- No physical or mental health issues that would prevent participation
- Not pregnant or willing to prevent pregnancy during treatment
Who cannot join
- Carbon monoxide (CO) breath test score below 10 parts per million (ppm)
- Center for Epidemiologic Studies Depression Scale (CES-D) score greater than 16
- Heavy alcohol use
- History of eating disorder
- Suicidality
Trial locations and contacts
1 site in 1 country.
United States1 site
UW Center for Tobacco Research and Intervention
Madison, Wisconsin, 53711
About this study
Official title: Efficacy of Bupropion Alone and in Combination With Nicotine Gum
Focus of this study was to determine if bupropion was more effective for smoking cessation when used alone or combined with nicotine gum.
- Conditions
- Tobacco Dependence
- Being tested
- bupropion + nicotine gum, Active bupropion-Placebo gum, Placebo bupropion-Placebo gum
- Keywords
- smoking cessation, tobacco dependence
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupropion + nicotine gumDrug
150 mg bupropion twice daily plus 4 mg nicotine gum as needed (up to 12 pcs/day)
Active bupropion-Placebo gumDrug
150mg bupropion twice daily plus placebo nicotine gum as needed (up to 12 pcs/day)
Placebo bupropion-Placebo gumDrug
Placebo bupropion twice daily + placebo nicotine gum as needed (up to 12 pcs/day)
| Study group | Role | What they receive |
|---|---|---|
| Active bupropion-Active gum | Active comparator | 150 mg bupropion twice daily + 4 mg nicotine gum as needed (up to 12 pcs/day) Receives: Drug: bupropion + nicotine gum |
| Active bupropion-Placebo gum | Active comparator | 150mg bupropion twice daily + placebo gum as needed (up to 12 pcs/day) Receives: Drug: Active bupropion-Placebo gum |
| Placebo medication-Placebo gum | Active comparator | Placebo bupropion, twice daily, plus placebo gum as needed (up to 12 pcs/day) Receives: Drug: Placebo bupropion-Placebo gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day point prevalence abstinence measured at 6 months
No smoking, not evan a puff, during the 7 days prior to the 6 month follow-up
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2012 (estimated)
- Study startJan 2001
- Primary completionOct 2002
- Study completionOct 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tobacco DependenceStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 608 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01621022
- Sponsor's protocol ID
- IRB S-01-07
- Status last verified
- Dec 2016
- First submitted
- 13 Jun 2012
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Piper ME, Federman EB, McCarthy DE, Bolt DM, Smith SS, Fiore MC, Baker TB. Efficacy of bupropion alone and in combination with nicotine gum. Nicotine Tob Res. 2007 Sep;9(9):947-54. doi: 10.1080/14622200701540820.
PubMed 17763111Hajizadeh 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 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Bupropion Alone and in Combination With Nicotine Gum
- ClinicalTrials.gov ID
- NCT01621022
- Acronym / sponsor ID
- IRB S-01-07
- Conditions
- Tobacco Dependence
- Keywords
- smoking cessation, tobacco dependence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 608 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jan 2001
- Primary completion
- Oct 2002 (actual)
- Study completion
- Oct 2002 (actual)
- First posted
- 15 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Focus of this study was to determine if bupropion was more effective for smoking cessation when used alone or combined with nicotine gum.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active bupropion-Active gum | Active comparator | Drug: bupropion + nicotine gum150 mg bupropion twice daily + 4 mg nicotine gum as needed (up to 12 pcs/day) |
| Active bupropion-Placebo gum | Active comparator | Drug: Active bupropion-Placebo gum150mg bupropion twice daily + placebo gum as needed (up to 12 pcs/day) |
| Placebo medication-Placebo gum | Active comparator | Drug: Placebo bupropion-Placebo gumPlacebo bupropion, twice daily, plus placebo gum as needed (up to 12 pcs/day) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Smoke 10 or more cigarettes per day
- Motivated to quit
- No physical or mental health issues that would prevent participation
- Not pregnant or willing to prevent pregnancy during treatment
Key exclusion criteria (5 listed)
- Carbon monoxide (CO) breath test score below 10 parts per million (ppm)
- Center for Epidemiologic Studies Depression Scale (CES-D) score greater than 16
- Heavy alcohol use
- History of eating disorder
- Suicidality
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 |
|---|---|---|
| bupropion + nicotine gum150 mg bupropion twice daily plus 4 mg nicotine gum as needed (up to 12 pcs/day) | Drug | Active bupropion-Active gum |
| Active bupropion-Placebo gum150mg bupropion twice daily plus placebo nicotine gum as needed (up to 12 pcs/day) | Drug | Active bupropion-Placebo gum |
| Placebo bupropion-Placebo gumPlacebo bupropion twice daily + placebo nicotine gum as needed (up to 12 pcs/day) | Drug | Placebo medication-Placebo gum |
Primary outcome
7-day point prevalence abstinence measured at 6 months
Time frame: 6 months
No smoking, not evan a puff, during the 7 days prior to the 6 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2016.
- Results publication: PubMed 17763111Piper ME, Federman EB, McCarthy DE, Bolt DM, Smith SS, Fiore MC, Baker TB. Efficacy of bupropion alone and in combination with nicotine gum. Nicotine Tob Res. 2007 Sep;9(9):947-54. doi: 10.1080/14622200701540820.
- 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 + nicotine gum in people with Tobacco Dependence, run by University of Wisconsin, Madison 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 4 inclusion and 5 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 6 Dec 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
7-day point prevalence abstinence measured at 6 months (time frame: 6 months). 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 NCT01621022, 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 6 Dec 2016.