Unspecified Adult Solid Tumor, Protocol SpecificNCT00278226
Motivational Program for Smokers Enrolled in a Methadone Maintenance Program
A study testing smoking cessation intervention and educational intervention in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Butler Hospital at 1 site in United States.
Trial summary
RATIONALE: Stop-smoking programs may help patients stop smoking and prevent cancer from forming. PURPOSE: This clinical trial is studying how well a motivational program works in helping smokers enrolled in a methadone maintenance program quit smoking. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- smoking cessation intervention and educational intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 398 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2001to Oct 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Must be currently enrolled in a methadone maintenance program
- Smokes at least 10 cigarettes a day
PATIENT CHARACTERISTICS:
- Not pregnant
- No concurrent medical condition that precludes the use of nicotine patches
PRIOR CONCURRENT THERAPY:
- No concurrent use of other nicotine replacement therapy
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: Smoking Cessation Among Methadone Maintained Patients
RATIONALE: Stop-smoking programs may help patients stop smoking and prevent cancer from forming.
PURPOSE: This clinical trial is studying how well a motivational program works in helping smokers enrolled in a methadone maintenance program quit smoking.
Read the detailed description
OBJECTIVES:
- Determine the efficacy of a brief motivational intervention on smoking cessation in smokers enrolled in a methadone maintenance program.
OUTLINE: Patients are assigned to 1 of 2 groups.
- Group 1: Patients undergo assessment at baseline and at 1, 3, and 6 months.
- Group 2: Patients receive a brief motivational intervention at the time of their baseline assessment and undergo assessment as in group 1.
All patients will be offered a 2- to 3-month supply of nicotine patches.
PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.
- Being tested
- smoking cessation intervention, educational intervention
- Keywords
- 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
educational interventionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Nicotine Abstinence
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 posted18 Jan 2006 (estimated)
- Study startJun 2001
- Primary completionOct 2004
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies 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
- None (open label)
- Enrolment
- 398 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Michael Stein, MD, Study chair, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00278226
- Sponsor's protocol ID
- CDR0000452798
- Other IDs
- R01CA084392, RIH-0076-98
- Status last verified
- Mar 2010
- First submitted
- 16 Jan 2006
- Last updated
- 24 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Cessation Among Methadone Maintained Patients
- ClinicalTrials.gov ID
- NCT00278226
- Acronym / sponsor ID
- CDR0000452798
- Keywords
- unspecified adult solid tumor, protocol specific
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 398 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2001
- Primary completion
- Oct 2004 (actual)
- Study completion
- Oct 2004 (actual)
- First posted
- 18 Jan 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.
RATIONALE: Stop-smoking programs may help patients stop smoking and prevent cancer from forming.
PURPOSE: This clinical trial is studying how well a motivational program works in helping smokers enrolled in a methadone maintenance program quit smoking.
Detailed description
OBJECTIVES:
- Determine the efficacy of a brief motivational intervention on smoking cessation in smokers enrolled in a methadone maintenance program.
OUTLINE: Patients are assigned to 1 of 2 groups.
- Group 1: Patients undergo assessment at baseline and at 1, 3, and 6 months.
- Group 2: Patients receive a brief motivational intervention at the time of their baseline assessment and undergo assessment as in group 1.
All patients will be offered a 2- to 3-month supply of nicotine patches.
PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- 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 | – |
| educational intervention | Other | – |
Primary outcome
Nicotine Abstinence
Time frame: 6-months
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 24 Mar 2010.
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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
Rhode Island 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 smoking cessation intervention and educational intervention in people with Unspecified Adult Solid Tumor, Protocol Specific, 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?
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 24 Mar 2010. 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?
Nicotine Abstinence (time frame: 6-months). It is what the study was designed to measure, not a finding.
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 24 Mar 2010; AzTrials last refreshed its copy on 5 Nov 2026.