Bladder CancerNCT00790569
Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking
A study testing nicotine and varenicline in people with Bladder Cancer and Cervical Cancer, run by Butler Hospital at 1 site in United States.
Trial summary
RATIONALE: Varenicline, the nicotine patch, and nicotine gum help people stop smoking. It is not yet known whether varenicline is more effective than the nicotine patch given together with nicotine gum in helping smokers quit smoking. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Bladder Cancer, Cervical Cancer, Esophageal Cancer
- What is being tested?
- nicotine and varenicline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 315 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Oct 2012
- Phase
- Interventional
- 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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current and regular cigarette smokers (over 10 cigarettes/day for the past 3 months)
- Interested in quitting smoking
- Willing to set a quit date 7 days after baseline assessment
- Participating in 1 of 5 methadone maintenance treatment programs across Rhode Island at any of the following institutions:
- Codac, Inc. (with two independent sites)
- Addiction Recovery Institute
Show all 9Show fewer
- Center for Treatment and Recovery
- Discovery House
- Has received methadone for at least the past month
Who cannot join
- Pregnant or nursing (Must have negative pregnancy test)
- Non-English speaking
- No personal telephone or does not live close to a relative or neighbor with a telephone
- Unwilling to make their methadone dose and methadone maintenance treatment program urine toxicologies available for review
- Unvailable for this study for the next 12 months
- Suffering from any unstable medical condition which would preclude the use of the nicotine patch (e.g., unstable angina or uncontrolled hypertension)
Show all 14Show fewer
- Active skin condition (e.g., psoriasis)
- History of skin allergy
- History of a suicide attempt
- Working as pilots, drivers, or operators of heavy machinery
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No concurrent insulin or blood thinners
- No concurrent smokeless tobacco, nicotine replacement therapy, or other smoking cessation treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital Comprehensive Cancer Center
Providence, Rhode Island, 02903
About this study
Official title: Varenicline Versus Nicotine Replacement for Methadone-Maintained Smokers
RATIONALE: Varenicline, the nicotine patch, and nicotine gum help people stop smoking. It is not yet known whether varenicline is more effective than the nicotine patch given together with nicotine gum in helping smokers quit smoking.
PURPOSE: This randomized clinical trial is studying varenicline to see how well it works compared with the nicotine patch given together with nicotine gum in helping smokers in a methadone treatment program stop smoking.
Read the detailed description
OBJECTIVES:
Primary
- To determine whether varenicline, a nicotine receptor partial agonist, leads to a higher rate of smoking cessation than combination nicotine replacement therapy with nicotine patch prescription plus ad libitum nicotine gum delivery in methadone-maintained smokers.
Secondary
- To test the effects of the treatments on smoking urges, withdrawal symptoms, and reinforcing effects of smoking.
- To test the effects of the treatments on methadone treatment outcomes, including retention in methadone maintenance, methadone dose changes, and continued use of illicit drugs as measured by urine toxicologies.
OUTLINE: This is a multicenter study. Patients are stratified based on gender and level of nicotine dependence. Patients are randomized to 1 of 3 intervention arms.
At baseline, all patients receive a minimal behavioral intervention using a 3-minute, simple smoking cessation counseling strategy, a self-help manual, and a telephone quit-line number.
- Arm I (varenicline): Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
- Arm II (placebo): Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
- Arm III (nicotine patch/gum): Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.
Patients complete a brief interview over 10-15 minutes at 2 weeks and monthly during months 1-5. They complete a longer interview over 45 minutes at months 6 and 12 and provide breath samples (for carbon monoxide monitoring) and urine samples (for cotinine testing).
NOTE: Smoking cessation may prevent certain smoking-related illnesses, including cancer.
PROJECTED ACCRUAL: A total of 602 patients (258 receiving varenicline, 258 receiving nicotine replacement therapy, and 86 receiving placebo) will be accrued for this study.
- Conditions
- Bladder Cancer, Cervical Cancer, Esophageal Cancer, Gastric Cancer, Head and Neck Cancer, Kidney Cancer
- Being tested
- nicotine, varenicline, placebo
- Keywords
- bladder cancer, cervical cancer, esophageal cancer, gastric cancer, renal cell carcinoma, adult primary liver cancer, non-small cell lung cancer, small cell lung cancer, pancreatic cancer, hypopharyngeal cancer, laryngeal cancer, lip and oral cavity cancer, nasopharyngeal cancer, oropharyngeal cancer, paranasal sinus and nasal cavity cancer, adult acute myeloid leukemia, tobacco use disorder
- Medical subject headings
- Urinary Bladder Neoplasms, Uterine Cervical Neoplasms, Esophageal Neoplasms, Stomach Neoplasms, Head and Neck Neoplasms, Kidney Neoplasms, Leukemia, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nicotineDrug
Given transdermally and orally
vareniclineDrug
Given orally
placeboOther
Given orally
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached. Receives: Drug: varenicline |
| Arm II | Placebo comparator | Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached. Receives: Other: placebo |
| Arm III | Active comparator | Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached. Receives: Drug: nicotine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self- Reported 7-day Abstinence
Number of participants with self-reported, 7-day abstinence at 6-months
Measured: 6 Months
Carbon Monoxide (CO)-Confirmed 7-day Abstinence
Number of participants reporting 7-day abstinence at 6-months, confirmed with CO measurement.
Measured: 6-Months
Rates of Smoking Cessation Continuous From First Quit Day to 6 Months
Number of participants who self-reported continuous abstinence from their initial quit day (study day 14) to 6 Months
Measured: 6-Months
Self-reported 7-day Abstinence
Number of participants with self-reported 7-day abstinence at 12-months
Measured: 12 Months
CO-confirmed 7-day Abstinence
Number of participants reporting 7-day abstinence at 12-months, confirmed with CO measurement.
Measured: 12 Months
Secondary outcomes (7)
Change in Smoking Urges
Smoking urges was measured on a 0 (not at all) - 100 (strongest feeling possible) scale. Higher values represent greater urge to smoke. Change in smoking urges was calculated as Follow-up score (6 month) - Baseline Score.
Measured: 6 months
Withdrawal Symptoms
Withdrawal Symptoms were measured using a modified version of the Minnesota Behavior Rating Scale. The scale asked subjects to rate their smoking withdrawal symptoms over the previous 24 hours on a scale from 0 (none) to 4 (severe). Higher values indicate more severe withdrawal symptoms. Change in withdrawal symptoms was calculated as Follow-up score (6 month) - Baseline Score.
Measured: 6 months
Retention in Methadone Maintenance
Measured: 12 months
Methadone Dose Changes
Measured: 12 months
Use of Illicit Drugs as Measured by Urine Toxicologies
Measured: 12 months
Reinforcing Effects of Smoking
Reinforcing effects of smoking was measured using the modified version of the Cigarette Evaluation Questionnaire. Participants were asked to indicate on a 12-item scale how smoking made them feel in the prior 30 days on a scale from 1 (Not at all) to 7 (Extremely). Higher values indicated that smoking was a more positive experience for 10 of 12 items. Two items were reverse coded. Change in reinforcing effects of smoking was calculated as Follow-up score (6 month) - Baseline Score.
Measured: 6 months
Change in Cigarettes Per Day
Change in mean cigarettes per day
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 posted13 Nov 2008 (estimated)
- Study startSep 2008
- Primary completionOct 2012
- Study completionOct 2012
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 (4)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies 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
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Michael Stein, MD, Butler Hospital
- Investigators
- Michael Stein, MD, Study chair, Butler Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00790569
- Sponsor's protocol ID
- CDR0000616663
- Other IDs
- R01CA129226, BUTLER-0807-004
- Status last verified
- May 2018
- First submitted
- 11 Nov 2008
- Last updated
- 6 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Stein MD, Caviness CM, Kurth ME, Audet D, Olson J, Anderson BJ. Varenicline for smoking cessation among methadone-maintained smokers: a randomized clinical trial. Drug Alcohol Depend. 2013 Dec 1;133(2):486-93. doi: 10.1016/j.drugalcdep.2013.07.005. Epub 2013 Aug 14.
PubMed 23953658Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
PubMed 37142273de Dios MA, Anderson BJ, Caviness CM, Stein M. Intimate partner violence among individuals in methadone maintenance treatment. Subst Abus. 2014;35(2):190-3. doi: 10.1080/08897077.2013.835764.
PubMed 24821357Caviness CM, Bird JL, Anderson BJ, Abrantes AM, Stein MD. Minimum recommended physical activity, and perceived barriers and benefits of exercise in methadone maintained persons. J Subst Abuse Treat. 2013 Apr;44(4):457-62. doi: 10.1016/j.jsat.2012.10.002. Epub 2012 Nov 28.
PubMed 23199641
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Varenicline Versus Nicotine Replacement for Methadone-Maintained Smokers
- ClinicalTrials.gov ID
- NCT00790569
- Acronym / sponsor ID
- CDR0000616663
- Conditions
- Bladder Cancer, Cervical Cancer, Esophageal Cancer, Gastric Cancer, Head and Neck Cancer, Kidney Cancer
- Keywords
- bladder cancer, cervical cancer, esophageal cancer, gastric cancer, renal cell carcinoma, adult primary liver cancer, non-small cell lung cancer, small cell lung cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2008
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 13 Nov 2008 (estimated)
- Results
- Posted 3 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Varenicline, the nicotine patch, and nicotine gum help people stop smoking. It is not yet known whether varenicline is more effective than the nicotine patch given together with nicotine gum in helping smokers quit smoking.
PURPOSE: This randomized clinical trial is studying varenicline to see how well it works compared with the nicotine patch given together with nicotine gum in helping smokers in a methadone treatment program stop smoking.
Detailed description
OBJECTIVES:
Primary
- To determine whether varenicline, a nicotine receptor partial agonist, leads to a higher rate of smoking cessation than combination nicotine replacement therapy with nicotine patch prescription plus ad libitum nicotine gum delivery in methadone-maintained smokers.
Secondary
- To test the effects of the treatments on smoking urges, withdrawal symptoms, and reinforcing effects of smoking.
- To test the effects of the treatments on methadone treatment outcomes, including retention in methadone maintenance, methadone dose changes, and continued use of illicit drugs as measured by urine toxicologies.
OUTLINE: This is a multicenter study. Patients are stratified based on gender and level of nicotine dependence. Patients are randomized to 1 of 3 intervention arms.
At baseline, all patients receive a minimal behavioral intervention using a 3-minute, simple smoking cessation counseling strategy, a self-help manual, and a telephone quit-line number.
- Arm I (varenicline): Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
- Arm II (placebo): Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
- Arm III (nicotine patch/gum): Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.
Patients complete a brief interview over 10-15 minutes at 2 weeks and monthly during months 1-5. They complete a longer interview over 45 minutes at months 6 and 12 and provide breath samples (for carbon monoxide monitoring) and urine samples (for cotinine testing).
NOTE: Smoking cessation may prevent certain smoking-related illnesses, including cancer.
PROJECTED ACCRUAL: A total of 602 patients (258 receiving varenicline, 258 receiving nicotine replacement therapy, and 86 receiving placebo) will be accrued for this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: vareniclinePatients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached. |
| Arm II | Placebo comparator | Other: placeboPatients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached. |
| Arm III | Active comparator | Drug: nicotinePatients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Current and regular cigarette smokers (over 10 cigarettes/day for the past 3 months)
- Interested in quitting smoking
- Participating in 1 of 5 methadone maintenance treatment programs across Rhode Island at any of the following institutions:
- Has received methadone for at least the past month
Key exclusion criteria (14 listed)
- Pregnant or nursing (Must have negative pregnancy test)
- Non-English speaking
- No personal telephone or does not live close to a relative or neighbor with a telephone
- Unwilling to make their methadone dose and methadone maintenance treatment program urine toxicologies available for review
- Unvailable for this study for the next 12 months
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 |
|---|---|---|
| nicotineGiven transdermally and orally | Drug | Arm III |
| vareniclineGiven orally | Drug | Arm I |
| placeboGiven orally | Other | Arm II |
Primary outcome
Self- Reported 7-day Abstinence
Time frame: 6 Months
Number of participants with self-reported, 7-day abstinence at 6-months
Carbon Monoxide (CO)-Confirmed 7-day Abstinence
Time frame: 6-Months
Number of participants reporting 7-day abstinence at 6-months, confirmed with CO measurement.
Rates of Smoking Cessation Continuous From First Quit Day to 6 Months
Time frame: 6-Months
Number of participants who self-reported continuous abstinence from their initial quit day (study day 14) to 6 Months
Self-reported 7-day Abstinence
Time frame: 12 Months
Number of participants with self-reported 7-day abstinence at 12-months
CO-confirmed 7-day Abstinence
Time frame: 12 Months
Number of participants reporting 7-day abstinence at 12-months, confirmed with CO measurement.
7 secondary outcomes
Change in Smoking Urges
Time frame: 6 months
Withdrawal Symptoms
Time frame: 6 months
Retention in Methadone Maintenance
Time frame: 12 months
Methadone Dose Changes
Time frame: 12 months
Use of Illicit Drugs as Measured by Urine Toxicologies
Time frame: 12 months
Reinforcing Effects of Smoking
Time frame: 6 months
Change in Cigarettes Per Day
Time frame: 6-Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23953658Stein MD, Caviness CM, Kurth ME, Audet D, Olson J, Anderson BJ. Varenicline for smoking cessation among methadone-maintained smokers: a randomized clinical trial. Drug Alcohol Depend. 2013 Dec 1;133(2):486-93. doi: 10.1016/j.drugalcdep.2013.07.005. Epub 2013 Aug 14.
- Derived from this study: PubMed 37142273Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
- Derived from this study: PubMed 24821357de Dios MA, Anderson BJ, Caviness CM, Stein M. Intimate partner violence among individuals in methadone maintenance treatment. Subst Abus. 2014;35(2):190-3. doi: 10.1080/08897077.2013.835764.
- Derived from this study: PubMed 23199641Caviness CM, Bird JL, Anderson BJ, Abrantes AM, Stein MD. Minimum recommended physical activity, and perceived barriers and benefits of exercise in methadone maintained persons. J Subst Abuse Treat. 2013 Apr;44(4):457-62. doi: 10.1016/j.jsat.2012.10.002. Epub 2012 Nov 28.
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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.
Michael Stein, MD study chair
Butler Hospital
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 and varenicline in people with Bladder Cancer and Cervical Cancer, run by Butler Hospital 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 9 inclusion and 14 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 Jun 2018. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2014). 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?
Self- Reported 7-day Abstinence (time frame: 6 Months). The study lists 5 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 NCT00790569, which also lists 4 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 Jun 2018.