Tobacco Use DisorderNCT00308763
Nicotine Patch and Bupropion to Reduce Smoking Rates in Younger, Low-Income, and Minority Individuals
A study testing Nicotine Patch and Sustained Release Bupropion in people with Tobacco Use Disorder, run by University of Tennessee at 1 site in United States.
Trial summary
Nicotine addiction is a serious health problem in the United States; 46 million people smoke cigarettes, and 70% of those are trying to quit. The nicotine patch and bupropion, a medication used to reduce nicotine cravings, are two commonly used smoking cessation aids. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Nicotine Patch and Sustained Release Bupropion
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 594 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Dec 2008
- Phase
- Interventional
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- In good health
- In a lower socioeconomic group, defined as below median income in the study county
- Smokes more than 5 cigarettes each day for at least 6 months prior to study entry, as determined by self-report
Who cannot join
- History of a seizure disorder, brain tumor, or severe head trauma
- History of substance abuse, including alcohol use in excess of 14 drinks a week
- History of anorexia or bulimia
- History of cerebral, coronary, or peripheral vascular disease
- History of serious heart arrhythmia
- Presence of an unstable psychiatric illness
Show all 18Show fewer
- Current use of a psychotropic medication, including antidepressant medications
- History of peptic ulcer disease or currently taking an H2 blocker (e.g., cimetidine)
- History of kidney disease, defined as creatinine levels greater than 1.5 times the upper limit of normal
- History of liver disease, defined as serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic transaminase(SGPT) levels greater than twice the upper limit of normal
- History of uncontrolled hyperthyroidism or pheochromocytoma
- History of atopic or eczematous dermatitis
- Current use of a medication that cannot be discontinued and may interfere with study procedures or may increase the risk of side effects (e.g., nicotine gum, nicotine nasal spray, theophylline, systemic steroids, levodopa)
- History of an allergic reaction to the nicotine patch or bupropion
- History of diabetes treated with an oral agent or insulin
- Uncontrolled high blood pressure, defined as blood pressure level greater than 140/90 mm Hg
- Severe uncontrolled asthma, bronchitis, or emphysema
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Tennessee Health Science Center / Department of Preventive Medicine
Memphis, Tennessee, 38105
About this study
Official title: Clinical Trial of Two Medications on Smoking Cessation
Nicotine addiction is a serious health problem in the United States; 46 million people smoke cigarettes, and 70% of those are trying to quit. The nicotine patch and bupropion, a medication used to reduce nicotine cravings, are two commonly used smoking cessation aids. Both have been shown to reduce smoking rates, however, the effectiveness of combining the two treatments has not been widely examined. This study will evaluate the effectiveness of the nicotine patch combined with bupropion at reducing smoking rates among younger, low-income, and minority individuals.
Read the detailed description
Cigarette smoking poses a serious but preventable health risk. The negative health effects of smoking are well-known, but the prevalence of cigarette smoking remains high in the United States, particularly among younger people, people of lower socioeconomic status, and minority groups. Nicotine replacement therapy, commonly known as the nicotine patch, has been proven to be an effective treatment for reducing nicotine use. The nicotine patch provides a measured dose of nicotine through the skin. By gradually lowering nicotine doses over a period of time, individuals experience fewer nicotine cravings; the ultimate goal is to stop using nicotine. Bupropion, a medication commonly used to treat depression, is also used as a smoking cessation tool. It helps to control nicotine cravings. The majority of studies on the nicotine patch and bupropion have been performed on older, white, middle-class individuals; more research is needed to confirm the benefit of these treatments in younger, low-income, and minority populations. While both the nicotine patch and bupropion appear to be individually effective as smoking cessation aids, little is known on the possible effectiveness of combining the two treatments. Because of the high relapse rates in low-income and minority individuals, the combination of the nicotine patch with bupropion may be particularly effective at reducing relapse rates in these individuals. The purpose of this study is to evaluate the effectiveness of the nicotine patch and bupropion at reducing smoking rates in younger, low-income, and minority individuals.
This 1-year study will enroll younger, low-income, and minority individuals who smoke. Participants will be randomly assigned to one of the following three groups: 1) nicotine patch plus placebo sustained-release bupropion; 2) placebo nicotine patch plus sustained-release bupropion; or 3) nicotine patch plus sustained-release bupropion. At study entry, participants will complete standardized psychological questionnaires to assess depression levels and will undergo a physical exam and blood testing. Study visits will take place at Weeks 5 and 11, Month 6, and Year 1. At each visit, questionnaires will be completed, and smoking cessation rates will be assessed by self-report and verified by saliva and exhaled carbon monoxide testing. In addition, all participants will take part in a standardized behavioral smoking cessation program.
- Conditions
- Tobacco Use Disorder
- Being tested
- Nicotine Patch, Sustained Release Bupropion
- Keywords
- Smoking Cessation, Nicotine 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.
Nicotine PatchDrug
After determining that it is appropriate to dispense study medication to a participant, the dosing regimen will be determined. Participants who report smoking more than 20 cigarettes each day will be initially placed on the 21 mg patch; participants who report smoking 10 - 19 cigarettes each day will be initially placed on the 14 mg patch; participants who report smoking 5 - 9 cigarettes will be initially placed on the 7 mg patch.
If a participant is initially placed on the 21 mg patch, the following dosing schedule will occur: 21 mg patch for 4 weeks, 14 mg patch for 4 weeks, 7 mg patch for 2 weeks, and then off. If a participant is initially placed on the 14 mg patch, the following dosing schedule will occur: 14 mg patch for 6 weeks, 7 mg patch for 4 weeks, and then off. If a participant is initially placed on the 7 mg patch, the following dosing schedule will occur: 7 mg patch for 10 weeks, and then off.
Sustained Release BupropionDrug
Participants will receive the sustained-release bupropion 150 mg tablet in the morning for four days. If this dose is well-tolerated, then the dose will be increased to a 150 mg tablet twice daily, with at least 8 hours between the two doses. The sustained-release bupropion medication will begin at the randomization visit (RV) which is approximately one week before the quit date. At the RV, the participant should be dispensed enough of the 150 mg tablets of the sustained-release bupropion or placebo to return for the first follow-up visit with instructions on use. Participants will be evaluated by telephone on their quit date approximately one week after the RV to assess safety. We will discontinue the sustained-release bupropion at the second follow-up visit, at which time participants will have received sustained-release bupropion for approximately 11 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Nicotine patch plus placebo sustained-release bupropion Receives: Drug: Nicotine Patch |
| 2 | Active comparator | Placebo nicotine patch plus sustained-release bupropion Receives: Drug: Sustained Release Bupropion |
| 3 | Active comparator | Nicotine patch plus sustained-release bupropion Receives: Drug: Nicotine Patch; Drug: Sustained Release Bupropion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking cessation rates (measured by self-report, saliva test, and exhaled carbon monoxide test)
Measured: Measured at 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2006 (estimated)
- Study startJan 2004
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 594 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Karen C. Johnson, MD, MPH, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00308763
- Sponsor's protocol ID
- 376
- Other IDs
- R01HL066025, R01HL066025-05
- Status last verified
- May 2014
- First submitted
- 28 Mar 2006
- Last updated
- 21 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Badrun F, Tolley B, Johnson KC. Smoking Cessation Interventions and Their Effects on Mood and Quit Pattern. In preparation 2014.
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Two Medications on Smoking Cessation
- ClinicalTrials.gov ID
- NCT00308763
- Acronym / sponsor ID
- 376
- Conditions
- Tobacco Use Disorder
- Keywords
- Smoking Cessation, Nicotine Dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 594 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 30 Mar 2006 (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.
Nicotine addiction is a serious health problem in the United States; 46 million people smoke cigarettes, and 70% of those are trying to quit. The nicotine patch and bupropion, a medication used to reduce nicotine cravings, are two commonly used smoking cessation aids. Both have been shown to reduce smoking rates, however, the effectiveness of combining the two treatments has not been widely examined. This study will evaluate the effectiveness of the nicotine patch combined with bupropion at reducing smoking rates among younger, low-income, and minority individuals.
Detailed description
Cigarette smoking poses a serious but preventable health risk. The negative health effects of smoking are well-known, but the prevalence of cigarette smoking remains high in the United States, particularly among younger people, people of lower socioeconomic status, and minority groups. Nicotine replacement therapy, commonly known as the nicotine patch, has been proven to be an effective treatment for reducing nicotine use. The nicotine patch provides a measured dose of nicotine through the skin. By gradually lowering nicotine doses over a period of time, individuals experience fewer nicotine cravings; the ultimate goal is to stop using nicotine. Bupropion, a medication commonly used to treat depression, is also used as a smoking cessation tool. It helps to control nicotine cravings. The majority of studies on the nicotine patch and bupropion have been performed on older, white, middle-class individuals; more research is needed to confirm the benefit of these treatments in younger, low-income, and minority populations. While both the nicotine patch and bupropion appear to be individually effective as smoking cessation aids, little is known on the possible effectiveness of combining the two treatments. Because of the high relapse rates in low-income and minority individuals, the combination of the nicotine patch with bupropion may be particularly effective at reducing relapse rates in these individuals. The purpose of this study is to evaluate the effectiveness of the nicotine patch and bupropion at reducing smoking rates in younger, low-income, and minority individuals.
This 1-year study will enroll younger, low-income, and minority individuals who smoke. Participants will be randomly assigned to one of the following three groups: 1) nicotine patch plus placebo sustained-release bupropion; 2) placebo nicotine patch plus sustained-release bupropion; or 3) nicotine patch plus sustained-release bupropion. At study entry, participants will complete standardized psychological questionnaires to assess depression levels and will undergo a physical exam and blood testing. Study visits will take place at Weeks 5 and 11, Month 6, and Year 1. At each visit, questionnaires will be completed, and smoking cessation rates will be assessed by self-report and verified by saliva and exhaled carbon monoxide testing. In addition, all participants will take part in a standardized behavioral smoking cessation program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Nicotine PatchNicotine patch plus placebo sustained-release bupropion |
| 2 | Active comparator | Drug: Sustained Release BupropionPlacebo nicotine patch plus sustained-release bupropion |
| 3 | Active comparator | Drug: Nicotine Patch, Drug: Sustained Release BupropionNicotine patch plus sustained-release bupropion |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- In good health
- In a lower socioeconomic group, defined as below median income in the study county
- Smokes more than 5 cigarettes each day for at least 6 months prior to study entry, as determined by self-report
Key exclusion criteria (18 listed)
- History of a seizure disorder, brain tumor, or severe head trauma
- History of substance abuse, including alcohol use in excess of 14 drinks a week
- History of anorexia or bulimia
- History of cerebral, coronary, or peripheral vascular disease
- History of serious heart arrhythmia
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 |
|---|---|---|
| Nicotine PatchAfter determining that it is appropriate to dispense study medication to a participant, the dosing regimen will be determined. Participants who report smoking more than 20 cigarettes each day will be initially placed on the 21 mg patch; participants who report smoking 10 - 19 cigarettes each day will be initially placed on the 14 mg patch; participants who report smoking 5 - 9 cigarettes will be initially placed on the 7 mg patch. If a participant is initially placed on the 21 mg patch, the following dosing schedule will occur: 21 mg patch for 4 weeks, 14 mg patch for 4 weeks, 7 mg patch for 2 weeks, and then off. If a participant is initially placed on the 14 mg patch, the following dosing schedule will occur: 14 mg patch for 6 weeks, 7 mg patch for 4 weeks, and then off. If a participant is initially placed on the 7 mg patch, the following dosing schedule will occur: 7 mg patch for 10 weeks, and then off. | Drug | 1, 3 |
| Sustained Release BupropionParticipants will receive the sustained-release bupropion 150 mg tablet in the morning for four days. If this dose is well-tolerated, then the dose will be increased to a 150 mg tablet twice daily, with at least 8 hours between the two doses. The sustained-release bupropion medication will begin at the randomization visit (RV) which is approximately one week before the quit date. At the RV, the participant should be dispensed enough of the 150 mg tablets of the sustained-release bupropion or placebo to return for the first follow-up visit with instructions on use. Participants will be evaluated by telephone on their quit date approximately one week after the RV to assess safety. We will discontinue the sustained-release bupropion at the second follow-up visit, at which time participants will have received sustained-release bupropion for approximately 11 weeks. | Drug | 2, 3 |
Primary outcome
Smoking cessation rates (measured by self-report, saliva test, and exhaled carbon monoxide test)
Time frame: Measured at 1 year 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 21 May 2014.
- Results publicationBadrun F, Tolley B, Johnson KC. Smoking Cessation Interventions and Their Effects on Mood and Quit Pattern. In preparation 2014.
Related trials for Tobacco Use Disorder
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Social Media Support Groups for Adolescent Vaping Cessation
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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.
Karen C. Johnson, MD, MPH principal investigator
University of Tennessee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine Patch and Sustained Release Bupropion in people with Tobacco Use Disorder, run by University of Tennessee 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 18 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 May 2014. 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.
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?
Smoking cessation rates (measured by self-report, saliva test, and exhaled carbon monoxide test) (time frame: Measured at 1 year follow-up). 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 NCT00308763, which also lists 1 linked publication.
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 May 2014; AzTrials last refreshed its copy on 7 Nov 2026.