Tobacco DependencePhase 4NCT01621009
Bupropion SR Plus Counseling for Smoking Cessation
A Phase 4 study testing Active bupropion + counseling and Active bupropion, No counseling in people with Tobacco Dependence and Smoking, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this study was to determine if bupropion plus counseling was more effective than bupropion alone or counseling alone in helping smokers quit smoking. 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, Smoking
- What is being tested?
- Active bupropion + counseling and Active bupropion, No counseling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 463 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2001to Oct 2003
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Smoke 10 or more cigarettes per day
- Expired carbon monoxide (CO) level greater than 9 parts per million (ppm)
- Motivated to quit smoking (score of 3 on 4-point self-report scale)
- Willing to fulfill study requirements
Who cannot join
- Carbon monoxide breath test score below 9 ppm
- Serious psychopathology (bipolar disorder, psychosis)
- Center for Epidemiologic Studies Depression Scale CES-D)score over 16
- Contraindications for use of bupropion
- History of seizure disorder
- History of eating disorder
Show all 9Show fewer
- Current heavy drinking
- Risk of pregnancy
- Current breastfeeding
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: A Randomized Controlled Clinical Trial of Bupropion SR and Individual Smoking Cessation Counseling
The purpose of this study was to determine if bupropion plus counseling was more effective than bupropion alone or counseling alone in helping smokers quit smoking.
- Conditions
- Tobacco Dependence, Smoking
- Being tested
- Active bupropion + counseling, Active bupropion, No counseling, Placebo medication + counseling, Placebo medication, No counseling
- Keywords
- smoking cessation medications, smoking cessation counseling
- Medical subject headings
- Tobacco Use Disorder, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active bupropion + counselingDrug
Medications-Pre-quit: 150 mg bupropion per day 7 days before quit attempt, then 150 mg twice daily for 4 days before quit attempt; then 150 mg bupropion twice daily for eight weeks.
Counseling-Pre-quit: two 10 minutes sessions before quit date; eight 10-minute sessions post quit date.
Active bupropion, No counselingDrug
Medication - 150 mg bupropion per day starting week before quit day, then 150 mg twice daily 3 days before quit day, then 150 mg twice daily for eight weeks after quit day.
Counseling: No cessation counseling, only medication checks
Placebo medication + counselingDrug
Placebo bupropion once daily 7 days before quit day, then twice daily 4 days before quit attempt, then twice daily for 8 weeks after quit day.
Counseling: Two 10-minutes sessions before quit day, then eight 10-minutes sessions for eight weeks after quit day.
Placebo medication, No counselingDrug
Pre-quit: Placebo medication once daily 7 days before quit day, then twice daily before quit day, then twice daily for 8 weeks after quit day.
Counseling: No counseling, just medication checks
| Study group | Role | What they receive |
|---|---|---|
| Active bupropion + counseling | Active comparator | Active bupropion SR plus eight 10-minute individual counseling sessions. Receives: Drug: Active bupropion + counseling |
| Active bupropion , No counseling | Active comparator | Active bupropion, No counseling, only medication checks Receives: Drug: Active bupropion, No counseling |
| Placebo medication + counseling | Placebo comparator | Placebo bupropion plus eight 10-minute individual counseling sessions Receives: Drug: Placebo medication + counseling |
| Placebo medication, No counseling | Placebo comparator | Placebo bupropion, No counseling, just medication checks Receives: Drug: Placebo medication, No counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day Point Prevalence Abstinence From Smoking at 6 Months
No smoking, not even a puff, during the 7 days prior to the 6 month follow-up. Biochemically confirmed.
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 2003
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 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
- 463 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Timothy B Baker, PhD, Principal investigator, University of Wisconsin, MadisonTimothy B Baker, PhD, Study director, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01621009
- Sponsor's protocol ID
- 1998-369
- Other IDs
- P50CA084724, P50DA019706
- Status last verified
- Dec 2015
- First submitted
- 13 Jun 2012
- Last updated
- 27 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
McCarthy DE, Piasecki TM, Lawrence DL, Jorenby DE, Shiffman S, Fiore MC, Baker TB. A randomized controlled clinical trial of bupropion SR and individual smoking cessation counseling. Nicotine Tob Res. 2008 Apr;10(4):717-29. doi: 10.1080/14622200801968343.
PubMed 18418793Hajizadeh 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 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial of Bupropion SR and Individual Smoking Cessation Counseling
- ClinicalTrials.gov ID
- NCT01621009
- Acronym / sponsor ID
- 1998-369
- Conditions
- Tobacco Dependence, Smoking
- Keywords
- smoking cessation medications, smoking cessation counseling
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 463 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2001
- Primary completion
- Oct 2002 (actual)
- Study completion
- Oct 2003 (actual)
- First posted
- 15 Jun 2012 (estimated)
- Results
- Posted 27 Jan 2016
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 was to determine if bupropion plus counseling was more effective than bupropion alone or counseling alone in helping smokers quit smoking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active bupropion + counseling | Active comparator | Drug: Active bupropion + counselingActive bupropion SR plus eight 10-minute individual counseling sessions. |
| Active bupropion , No counseling | Active comparator | Drug: Active bupropion, No counselingActive bupropion, No counseling, only medication checks |
| Placebo medication + counseling | Placebo comparator | Drug: Placebo medication + counselingPlacebo bupropion plus eight 10-minute individual counseling sessions |
| Placebo medication, No counseling | Placebo comparator | Drug: Placebo medication, No counselingPlacebo bupropion, No counseling, just medication checks |
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
- Expired carbon monoxide (CO) level greater than 9 parts per million (ppm)
- Motivated to quit smoking (score of 3 on 4-point self-report scale)
- Willing to fulfill study requirements
Key exclusion criteria (9 listed)
- Carbon monoxide breath test score below 9 ppm
- Serious psychopathology (bipolar disorder, psychosis)
- Center for Epidemiologic Studies Depression Scale CES-D)score over 16
- Contraindications for use of bupropion
- History of seizure disorder
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 |
|---|---|---|
| Active bupropion + counselingMedications-Pre-quit: 150 mg bupropion per day 7 days before quit attempt, then 150 mg twice daily for 4 days before quit attempt; then 150 mg bupropion twice daily for eight weeks. Counseling-Pre-quit: two 10 minutes sessions before quit date; eight 10-minute sessions post quit date. | Drug | Active bupropion + counseling |
| Active bupropion, No counselingMedication - 150 mg bupropion per day starting week before quit day, then 150 mg twice daily 3 days before quit day, then 150 mg twice daily for eight weeks after quit day. Counseling: No cessation counseling, only medication checks | Drug | Active bupropion , No counseling |
| Placebo medication + counselingPlacebo bupropion once daily 7 days before quit day, then twice daily 4 days before quit attempt, then twice daily for 8 weeks after quit day. Counseling: Two 10-minutes sessions before quit day, then eight 10-minutes sessions for eight weeks after quit day. | Drug | Placebo medication + counseling |
| Placebo medication, No counselingPre-quit: Placebo medication once daily 7 days before quit day, then twice daily before quit day, then twice daily for 8 weeks after quit day. Counseling: No counseling, just medication checks | Drug | Placebo medication, No counseling |
Primary outcome
7-day Point Prevalence Abstinence From Smoking at 6 Months
Time frame: 6 months
No smoking, not even a puff, during the 7 days prior to the 6 month follow-up. Biochemically confirmed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18418793McCarthy DE, Piasecki TM, Lawrence DL, Jorenby DE, Shiffman S, Fiore MC, Baker TB. A randomized controlled clinical trial of bupropion SR and individual smoking cessation counseling. Nicotine Tob Res. 2008 Apr;10(4):717-29. doi: 10.1080/14622200801968343.
- 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.
Timothy B Baker, PhD principal investigator
University of Wisconsin, Madison
Timothy B Baker, PhD study director
University of Wisconsin, Madison
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 Active bupropion + counseling and Active bupropion, No counseling in people with Tobacco Dependence and Smoking, 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 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 27 Jan 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 27 Jan 2016). 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?
7-day Point Prevalence Abstinence From Smoking 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 NCT01621009, 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 27 Jan 2016.