Cancer SurvivorNCT00079469
Bupropion and Counseling With or Without Contingency Management to Enhance Smoking Cessation in Treating Cancer Survivors Who Continue to Smoke
A study testing smoking cessation intervention and bupropion hydrochloride in people with Cancer Survivor and Unspecified Adult Solid Tumor, Protocol Specific, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
RATIONALE: Contingency management is a behavioral treatment approach that provides immediate rewards for positive change in behavior such as quitting smoking. In this protocol, contingency management will be in the form of a cash reward. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Survivor, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- smoking cessation intervention and bupropion hydrochloride
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Aug 2004
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of cancer at least 6 months before study entry
- No carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, or CNS tumor
- Smoking history of at least 2 years
- Smoked cigarettes daily for the past 30 days
- Completed prior cancer treatment at least 6 months, but no more than 5 years before study entry
- Concurrent tamoxifen allowed
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Platelet count ≥ 100,000 - 450,000/mm^3
- WBC ≥ 3,000/mm^3
Hepatic
- AST and ALT ≤ 2 times upper limit of normal
- Bilirubin ≤ 2.0 mg/dL
Renal
- Creatinine < 2.0 mg/dL
Cardiovascular
- No unstable cardiovascular disease, including any of the following:
- High-grade atrioventricular block
- Neurocardiogenic syncope
- Unstable angina
- Uncompensated congestive heart failure
- Poorly controlled hypertension
Other
- Not pregnant or nursing
- Negative pregnancy test
- Able to undergo peripheral blood draw
- No port-a-cath or Hickman catheters
- Planning to reside in the Washington D.C. metro area for at least 1 year after study entry
- Willing to undergo urine testing for cotinine levels and breath testing for carbon monoxide monitoring
- No significant physical or psychological disability that would preclude study participation
- No known allergy to bupropion
- Baseline urine drug screen negative
- Prescribed pain medication allowed
- None of the following predisposing factors that may increase the risk of seizures with bupropion use:
- History of seizures
- Alcohol use > 4 oz/day
- History of closed head injury
- History of an eating disorder
- CNS infection
- No poorly controlled diabetes
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- See Disease Characteristics
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- At least 2 years since prior alcohol abuse or substance abuse therapy (except for tobacco use or dependence)
- More than 14 days since prior monoamine oxidase (MAO) inhibitor
- No concurrent MAO inhibitor
- No concurrent bupropion (Wellbutrin® or Wellbutrin SR®)
- No concurrent alcohol or substance abuse disorder treatment
- No concurrent nicotine replacement therapy
- No concurrent medications that lower seizure threshold (e.g., theophylline or short-acting benzodiazepines)
- No use of tobacco products (more than 1 time per week) other than cigarettes
Trial locations and contacts
1 site in 1 country.
United States1 site
Tobacco Control Research Branch
Rockville, Maryland, 20852
About this study
Official title: Contingency Management to Enhance Smoking Cessation for Cancer Survivors: A Proof of Concept Trial
RATIONALE: Contingency management is a behavioral treatment approach that provides immediate rewards for positive change in behavior such as quitting smoking. In this protocol, contingency management will be in the form of a cash reward. A smoking cessation (stop-smoking) program that combines contingency management with bupropion and counseling may be effective in helping cancer survivors stop smoking.
PURPOSE: Randomized clinical trial to compare the effectiveness of bupropion and counseling with or without contingency management in helping cancer survivors stop smoking.
Read the detailed description
OBJECTIVES:
Primary
- Compare the feasibility of a multi-component smoking cessation intervention comprising bupropion and counseling with or without contingency management (cash reward) for cancer survivors who continue to smoke.
- Compare 7-day point-prevalence abstinence rates in patients treated with these smoking cessation interventions.
Secondary
- Determine the characteristics of these patients that predict success at quitting smoking.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 smoking cessation intervention arms.
- Arm I: Patients receive oral bupropion twice daily on weeks 1-12 and brief practical counseling (i.e., problem-solving strategies, stimulus control, stress management, and social support) on weeks 1-6.
- Arm II: Patients receive treatment as in arm I and contingency management (i.e., monetary reinforcement for not smoking) on weeks 1-6.
In both arms, treatment continues in the absence of unacceptable toxicity.
Patients are followed at 12 and 24 weeks after the completion of the smoking cessation interventions.
PROJECTED ACCRUAL: A total of 100 patients (50 per intervention arm) will be accrued for this study within 8 months.
- Being tested
- smoking cessation intervention, bupropion hydrochloride
- Keywords
- cancer survivor, unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smoking cessation interventionBehavioural
bupropion hydrochlorideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2004 (estimated)
- Study startFeb 2004
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorStudies 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
- Prevention
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Glen D. Morgan, PhD, Principal investigator, NCI - Division of Cancer Control and Population ScienceSandra J. Schaefer, RN, BSN, OCN, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00079469
- Sponsor's protocol ID
- 999903308
- Other IDs
- 03-C-N308, CDR0000356037
- Status last verified
- Mar 2012
- First submitted
- 8 Mar 2004
- Last updated
- 8 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contingency Management to Enhance Smoking Cessation for Cancer Survivors: A Proof of Concept Trial
- ClinicalTrials.gov ID
- NCT00079469
- Acronym / sponsor ID
- 999903308
- Keywords
- cancer survivor, unspecified adult solid tumor, protocol specific
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2004
- Study completion
- Aug 2004 (actual)
- First posted
- 10 Mar 2004 (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.
RATIONALE: Contingency management is a behavioral treatment approach that provides immediate rewards for positive change in behavior such as quitting smoking. In this protocol, contingency management will be in the form of a cash reward. A smoking cessation (stop-smoking) program that combines contingency management with bupropion and counseling may be effective in helping cancer survivors stop smoking.
PURPOSE: Randomized clinical trial to compare the effectiveness of bupropion and counseling with or without contingency management in helping cancer survivors stop smoking.
Detailed description
OBJECTIVES:
Primary
- Compare the feasibility of a multi-component smoking cessation intervention comprising bupropion and counseling with or without contingency management (cash reward) for cancer survivors who continue to smoke.
- Compare 7-day point-prevalence abstinence rates in patients treated with these smoking cessation interventions.
Secondary
- Determine the characteristics of these patients that predict success at quitting smoking.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 smoking cessation intervention arms.
- Arm I: Patients receive oral bupropion twice daily on weeks 1-12 and brief practical counseling (i.e., problem-solving strategies, stimulus control, stress management, and social support) on weeks 1-6.
- Arm II: Patients receive treatment as in arm I and contingency management (i.e., monetary reinforcement for not smoking) on weeks 1-6.
In both arms, treatment continues in the absence of unacceptable toxicity.
Patients are followed at 12 and 24 weeks after the completion of the smoking cessation interventions.
PROJECTED ACCRUAL: A total of 100 patients (50 per intervention arm) will be accrued for this study within 8 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| smoking cessation intervention | Behavioural | – |
| bupropion hydrochloride | Drug | – |
Primary outcome
Not reported in the source record.
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 8 Mar 2012.
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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.
Glen D. Morgan, PhD principal investigator
NCI - Division of Cancer Control and Population Science
Sandra J. Schaefer, RN, BSN, OCN
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing smoking cessation intervention and bupropion hydrochloride in people with Cancer Survivor and Unspecified Adult Solid Tumor, Protocol Specific, run by National Institutes of Health Clinical Center (CC) 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?
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 8 Mar 2012. 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.
Where can I read the original study information?
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 8 Mar 2012.