Chronic DiseasesNCT00309296
Longitudinal Care: Smoking Reduction to Aid Cessation
A study testing smoking cessation in people with Chronic Diseases, run by National Institutes of Health (NIH) at 1 site in United States.
Trial summary
The purpose of this study is to determine whether an extended care treatment model lasting over a year will increase long-term smoking cessation rates compared to the standard 8 week treatment of care. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Diseases
- What is being tested?
- smoking cessation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 443 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Dec 2009
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-80
- Current and regular smoker 5 or more cigarettes per day
- Interested in making a quit attempt in the next 14 days
- Personal phone available
Who cannot join
- Pregnancy or plans to become pregnant in the next year
- Cannot speak English
- Not a union member or employee of specified worksite or immediate family member
- Member of household is currently enrolled in the study
- Not willing to comply with study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longitudinal Care: Smoking Reduction to Aid Cessation; Part of Hatsukami's Tobacco Exposure Reduction
The purpose of this study is to determine whether an extended care treatment model lasting over a year will increase long-term smoking cessation rates compared to the standard 8 week treatment of care.
Read the detailed description
Objective The objective of this project is to conduct a randomized controlled trial to compare 1) an extended quality care smoking cessation treatment delivered over a one-year period (EQC) to 2) quality care smoking cessation treatment delivered over an 8 week period (QC) to determine if EQC improves prolonged smoking abstinence.
Research Design/Methodology 500 smokers who are interested in quitting will be enrolled and randomly assigned to the EQC or QC groups. Both groups will initially receive a state-of-the-science smoking cessation intervention including behavioral and pharmacological components, delivered by a combination of in-person and telephone care. EQC participants who fail to quit, reduce but do not quit, or relapse will receive intensive treatment over the ensuing 12 months that encourages repeat quit attempts and smoking reduction if they are not to quit. We propose reduction as an intermediate goal in LC because this may increase the likelihood of cessation, increase self-efficacy and keep smokers and clinicians engaged. Reduction treatment will include behavioral treatment and nicotine replacement. QC participants will only receive occasional prompts to quit. The primary endpoint will be 6M of abstinence measured 18M after enrollment. Secondary endpoints will include point prevalent abstinence, smoking reduction, self-efficacy and satisfaction. We will also collect qualitative data from successful abstainers and reducers about decision making processes and intervention experiences.
Clinical Significance This project will address the potential role of smoking reduction in the treatment menu for smokers interested in quitting. This project examines mechanisms, methods and a "real world" application for reducing toxin exposure.
- Conditions
- Chronic Diseases
- Being tested
- smoking cessation
- Keywords
- smoking cessation, smoking reduction, nicotine replacement therapy
- Medical subject headings
- Chronic Disease, Smoking Cessation, Smoking Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smoking cessationBehavioural
This was a randomized controlled trial to compare long-term smoking cessation outcomes between Longitudinal Care (LC) and Usual Care (UC) treatment groups. The LC group received smoking cessation treatment (combined behavioral and pharmacological therapies) for one-year period. This treatment recommended repeat quit attempts or smoking reduction for those who failed to quit after the initial attempt. The UC group received evidence-based treatment that lasted 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Longitudinal Care | Experimental | One year of combined behavioral and pharamcological tobacco dependence treatment, with interim smoking reduciton for smokers who fail initial quit attempt. Receives: Behavioral: smoking cessation |
| Usual Care | Active comparator | Evidence based, state-of-the-science tobacco treatment; combined behavioral and pharmacological treatment for 8 weeks Receives: Behavioral: smoking cessation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be 6M of abstinence measured 18M after enrollment.
6M prolonged abstinence
Measured: 18M
Secondary outcomes (4)
7d point prevalent abstinence
Data collected at 21d, 3, 6, 12, 18M
Measured: 18M
30d point prevalent abstinence
Data collected at 3, 6, 12, 18M
Measured: 18M
Smoking reduction
Data collected at 3, 6, 12, 18M
Measured: 18M
Total duration of abstinence
Time Line Follow Back
Measured: 18M
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2006 (estimated)
- Study startNov 2005
- Primary completionNov 2009
- Study completionDec 2009
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 Chronic DiseasesStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 443 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health (NIH)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Investigators
- Anne M Joseph, MD, MPH, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00309296
- Sponsor's protocol ID
- TLC
- Other IDs
- P50DA013333-07
- Status last verified
- Feb 2011
- First submitted
- 30 Mar 2006
- Last updated
- 14 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Joseph AM, Fu SS, Lindgren B, Rothman AJ, Kodl M, Lando H, Doyle B, Hatsukami D. Chronic disease management for tobacco dependence: a randomized, controlled trial. Arch Intern Med. 2011 Nov 28;171(21):1894-900. doi: 10.1001/archinternmed.2011.500.
PubMed 22123795
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Care: Smoking Reduction to Aid Cessation; Part of Hatsukami's Tobacco Exposure Reduction
- ClinicalTrials.gov ID
- NCT00309296
- Acronym / sponsor ID
- TLC
- Conditions
- Chronic Diseases
- Keywords
- smoking cessation, smoking reduction, nicotine replacement therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 443 participants (actual)
- Lead sponsor
- National Institutes of Health (NIH)US National Institutes of Health
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Nov 2005
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 31 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.
The purpose of this study is to determine whether an extended care treatment model lasting over a year will increase long-term smoking cessation rates compared to the standard 8 week treatment of care.
Detailed description
Objective The objective of this project is to conduct a randomized controlled trial to compare 1) an extended quality care smoking cessation treatment delivered over a one-year period (EQC) to 2) quality care smoking cessation treatment delivered over an 8 week period (QC) to determine if EQC improves prolonged smoking abstinence.
Research Design/Methodology 500 smokers who are interested in quitting will be enrolled and randomly assigned to the EQC or QC groups. Both groups will initially receive a state-of-the-science smoking cessation intervention including behavioral and pharmacological components, delivered by a combination of in-person and telephone care. EQC participants who fail to quit, reduce but do not quit, or relapse will receive intensive treatment over the ensuing 12 months that encourages repeat quit attempts and smoking reduction if they are not to quit. We propose reduction as an intermediate goal in LC because this may increase the likelihood of cessation, increase self-efficacy and keep smokers and clinicians engaged. Reduction treatment will include behavioral treatment and nicotine replacement. QC participants will only receive occasional prompts to quit. The primary endpoint will be 6M of abstinence measured 18M after enrollment. Secondary endpoints will include point prevalent abstinence, smoking reduction, self-efficacy and satisfaction. We will also collect qualitative data from successful abstainers and reducers about decision making processes and intervention experiences.
Clinical Significance This project will address the potential role of smoking reduction in the treatment menu for smokers interested in quitting. This project examines mechanisms, methods and a "real world" application for reducing toxin exposure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Longitudinal Care | Experimental | Behavioral: smoking cessationOne year of combined behavioral and pharamcological tobacco dependence treatment, with interim smoking reduciton for smokers who fail initial quit attempt. |
| Usual Care | Active comparator | Behavioral: smoking cessationEvidence based, state-of-the-science tobacco treatment; combined behavioral and pharmacological treatment for 8 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-80
- Current and regular smoker 5 or more cigarettes per day
- Interested in making a quit attempt in the next 14 days
- Personal phone available
Key exclusion criteria (5 listed)
- Pregnancy or plans to become pregnant in the next year
- Cannot speak English
- Not a union member or employee of specified worksite or immediate family member
- Member of household is currently enrolled in the study
- Not willing to comply with study protocol
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 cessationThis was a randomized controlled trial to compare long-term smoking cessation outcomes between Longitudinal Care (LC) and Usual Care (UC) treatment groups. The LC group received smoking cessation treatment (combined behavioral and pharmacological therapies) for one-year period. This treatment recommended repeat quit attempts or smoking reduction for those who failed to quit after the initial attempt. The UC group received evidence-based treatment that lasted 8 weeks. | Behavioural | Longitudinal Care, Usual Care |
Primary outcome
The primary endpoint will be 6M of abstinence measured 18M after enrollment.
Time frame: 18M
6M prolonged abstinence
4 secondary outcomes
7d point prevalent abstinence
Time frame: 18M
30d point prevalent abstinence
Time frame: 18M
Smoking reduction
Time frame: 18M
Total duration of abstinence
Time frame: 18M
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 14 Feb 2011.
- Derived from this study: PubMed 22123795Joseph AM, Fu SS, Lindgren B, Rothman AJ, Kodl M, Lando H, Doyle B, Hatsukami D. Chronic disease management for tobacco dependence: a randomized, controlled trial. Arch Intern Med. 2011 Nov 28;171(21):1894-900. doi: 10.1001/archinternmed.2011.500.
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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.
Anne M Joseph, MD, MPH principal investigator
University of Minnesota
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 in people with Chronic Diseases, run by National Institutes of Health (NIH) 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 5 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 14 Feb 2011. 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?
The primary endpoint will be 6M of abstinence measured 18M after enrollment. (time frame: 18M). 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 NCT00309296, 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 14 Feb 2011.