Tobacco Use DisorderPhase 2/3STOPNCT01141855
Smoking Termination Opportunity for inPatients
A Phase 2/3 study testing Champix and Counselling alone in people with Tobacco Use Disorder, run by The Queen Elizabeth Hospital at 3 sites in Australia.
Trial summary
The Smoking Termination Opportunity for inPatients, (STOP) project is designed to capture the opportunity that is provided by admission for acute smoking related illness, to assist patients through withdrawal by use of a combination of: the new medication Champix with best practice counselling initiated in an… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Champix and Counselling alone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 3 sitesAustralia
- Study dates
- May 2008to Dec 2011
- Phase
- Phase 2/3
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Smoker of at least 10 cigarettes per day on average over the past 12 months
- Inpatient with an anticipation admission of at least one day
- Willingness to quit smoking
- Aged between 20 and 75 years
- A plan of discharge to go home
- Acute hospital admission with cardiovascular, cerebrovascular, peripheral vascular diseases or airways (asthma and/or Chronic Obstructive Pulmonary disease
Who cannot join
- Subject preference to use an alternative pharmacotherapy for smoking cessation
- Respiratory patient being considered for home oxygen
- Pregnancy
- Breast feeding
- Acute or pre-existing severe psychiatric illnesses
- Past history of psychosis or suicidal ideation
- Renal impairment with creatinine clearance <30ml/min
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
The Queen Elizabeth Hospital
Adelaide, South Australia, 5011
Lyell McEwin Health Service
Adelaide, South Australia, 5112
About this study
Official title: Effectiveness of Inpatient Initiated Varenicline Tartrate for Smoking Cessation, for Smoking Related Illnesses.
The Smoking Termination Opportunity for inPatients, (STOP) project is designed to capture the opportunity that is provided by admission for acute smoking related illness, to assist patients through withdrawal by use of a combination of:
- the new medication Champix with
- best practice counselling
- initiated in an inpatient setting to achieve:
- sustained smoking abstinence
- reduced hospital bed and health service utilisation
- reduced inpatient smoking and craving prior to discharge
Read the detailed description
A national standard in public hospitals for the management of smoking in patients admitted with smoking related acute illnesses is lacking. Where such patients have continued to smoke up until the time of admission, it can be assumed that "primary" prevention has failed.
Once admitted, there is a vastly under-utilised opportunity, by use of a structured and systematic approach, to intervene with a secondary prevention attempt. This takes advantage of the synergy of:
- the smoker is a "captive audience" and may be receptive to considering lifestyle factors that have lead to the admission, and
- best practice medication and counselling can be initiated prior to discharge. If proven to be cost-effective in our analysis, a systematic roll-out of this secondary prevention initiative would be advocated. ie translation of research into practice.
- Conditions
- Tobacco Use Disorder
- Being tested
- Champix, Counselling alone
- Keywords
- Cardiovascular Diseases, Peripheral Vascular Diseases, Cerebrovascular Stroke, Lung Diseases, Obstructive, Asthma, Tobacco Use Disorder, Smoking, Smoking Cessation
- Medical subject headings
- Tobacco Use Disorder, Cardiovascular Diseases, Peripheral Vascular Diseases, Stroke, Lung Diseases, Obstructive, Asthma, Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChampixDrug
Also called varenicline tartrate, Chantix
Standard MIMS dosage (including period of titration) will be used. 0.5mg daily for 3 days 0.5mg b.d. for 4 days
1mb b.d. for 70 days (full course 3 months)
Counselling aloneBehavioural
Also called Quitline counselling service
Quit SA 5A counselling over the phone. Maximum 8 calls over a 3 month period
| Study group | Role | What they receive |
|---|---|---|
| Champix plus counselling | Experimental | varenicline tartrate will be initiated whilst subjects are inpatients with the standard MIMS dosing schedule (including period of titration). In combination with Quit SA (5A) telephone counselling service Receives: Drug: Champix |
| counselling alone | Active comparator | 5A counselling via Quit SA (quitline) telephone counselling service. (maximum 8 phone calls per subject within a 3 month period). Receives: Behavioral: Counselling alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking abstinence
Continued smoking abstinence is defined as: less than or equal to no more than 5 cigarettes smoked during the period of 2 weeks to 12 months post enrollment.
Measured: one year
Secondary outcomes (5)
Reduced hospital bed utilisation
Hospital casemix/DRG data will be collected for the 5 years prior to enrollment and one year post enrollment. This will be supplemented by SA Department of Health data and PBS/MBS data sets of study completion, to monitor admissions at other hospitals and GP visits.
Measured: one year
7-day point prevalence
Defined as no cigarettes for the previous 7 days
Measured: from 2 weeks to 3 months post enrollment
Reduction in health care costs
Reduced health care costs with greater economic value will be relative to other health interventions. Four seperate economic models will be built for vascular diseases: cardiovascular, cerebrovascular and peripheral vascular diseases and airways diseases: asthma and/or chronic obstructive pulmonary disease. Each model will compare outcomes and costs for varenicline and counselling compared to counselling alone, and will incorporate epidemiological data on natural disease progression of smokers and previous smokers from the four disease profiles split by gender if indicated.
Measured: one year
Inpatient craving levels
Craving scales will be used to assess levels during inpatient stay (pre and post intervention delivery)
Measured: baseline to end of inpatient stay
Prevalence of inpatient smoking
Measured by self-report and observation by hospital and study staff prior to discharge.
Measured: From baseline to end of inpatient stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2010 (estimated)
- Study startMay 2008
- Primary completionDec 2011
- Study completionDec 2011
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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Queen Elizabeth Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Brian J Smith, MBBS; FRACP;PhD;Dip Clin Epid, Principal investigator, The Queen Elizabeth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01141855
- Sponsor's protocol ID
- 2008012
- Acronym
- STOP
- Status last verified
- Apr 2010
- First submitted
- 10 Jun 2010
- Last updated
- 8 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Smith BJ, Carson KV, Brinn MP, Labiszewski NA, Peters MJ, Fitridge R, Koblar SA, Jannes J, Veale AJ, Goldsworthy SJ, Litt J, Edwards D, Esterman AJ. Smoking Termination Opportunity for inPatients (STOP): superiority of a course of varenicline tartrate plus counselling over counselling alone for smoking cessation: a 12-month randomised controlled trial for inpatients. Thorax. 2013 May;68(5):485-6. doi: 10.1136/thoraxjnl-2012-202484. Epub 2012 Sep 19.
PubMed 22993168
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Inpatient Initiated Varenicline Tartrate for Smoking Cessation, for Smoking Related Illnesses.
- ClinicalTrials.gov ID
- NCT01141855
- Acronym / sponsor ID
- STOP / 2008012
- Conditions
- Tobacco Use Disorder
- Keywords
- Cardiovascular Diseases, Peripheral Vascular Diseases, Cerebrovascular Stroke, Lung Diseases, Obstructive, Asthma, Tobacco Use Disorder, Smoking, Smoking Cessation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- The Queen Elizabeth HospitalUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 11 Jun 2010 (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 Smoking Termination Opportunity for inPatients, (STOP) project is designed to capture the opportunity that is provided by admission for acute smoking related illness, to assist patients through withdrawal by use of a combination of:
- the new medication Champix with
- best practice counselling
- initiated in an inpatient setting to achieve:
- sustained smoking abstinence
- reduced hospital bed and health service utilisation
- reduced inpatient smoking and craving prior to discharge
Detailed description
A national standard in public hospitals for the management of smoking in patients admitted with smoking related acute illnesses is lacking. Where such patients have continued to smoke up until the time of admission, it can be assumed that "primary" prevention has failed.
Once admitted, there is a vastly under-utilised opportunity, by use of a structured and systematic approach, to intervene with a secondary prevention attempt. This takes advantage of the synergy of:
- the smoker is a "captive audience" and may be receptive to considering lifestyle factors that have lead to the admission, and
- best practice medication and counselling can be initiated prior to discharge. If proven to be cost-effective in our analysis, a systematic roll-out of this secondary prevention initiative would be advocated. ie translation of research into practice.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Champix plus counselling | Experimental | Drug: Champixvarenicline tartrate will be initiated whilst subjects are inpatients with the standard MIMS dosing schedule (including period of titration). In combination with Quit SA (5A) telephone counselling service |
| counselling alone | Active comparator | Behavioral: Counselling alone5A counselling via Quit SA (quitline) telephone counselling service. (maximum 8 phone calls per subject within a 3 month period). |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Smoker of at least 10 cigarettes per day on average over the past 12 months
- Inpatient with an anticipation admission of at least one day
- Willingness to quit smoking
- Aged between 20 and 75 years
- A plan of discharge to go home
Key exclusion criteria (7 listed)
- Subject preference to use an alternative pharmacotherapy for smoking cessation
- Respiratory patient being considered for home oxygen
- Pregnancy
- Breast feeding
- Acute or pre-existing severe psychiatric illnesses
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 |
|---|---|---|
| ChampixAlso: varenicline tartrate, ChantixStandard MIMS dosage (including period of titration) will be used. 0.5mg daily for 3 days 0.5mg b.d. for 4 days 1mb b.d. for 70 days (full course 3 months) | Drug | Champix plus counselling |
| Counselling aloneAlso: Quitline counselling serviceQuit SA 5A counselling over the phone. Maximum 8 calls over a 3 month period | Behavioural | counselling alone |
Primary outcome
Smoking abstinence
Time frame: one year
Continued smoking abstinence is defined as: less than or equal to no more than 5 cigarettes smoked during the period of 2 weeks to 12 months post enrollment.
5 secondary outcomes
Reduced hospital bed utilisation
Time frame: one year
7-day point prevalence
Time frame: from 2 weeks to 3 months post enrollment
Reduction in health care costs
Time frame: one year
Inpatient craving levels
Time frame: baseline to end of inpatient stay
Prevalence of inpatient smoking
Time frame: From baseline to end of inpatient stay
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 Aug 2012.
- Derived from this study: PubMed 22993168Smith BJ, Carson KV, Brinn MP, Labiszewski NA, Peters MJ, Fitridge R, Koblar SA, Jannes J, Veale AJ, Goldsworthy SJ, Litt J, Edwards D, Esterman AJ. Smoking Termination Opportunity for inPatients (STOP): superiority of a course of varenicline tartrate plus counselling over counselling alone for smoking cessation: a 12-month randomised controlled trial for inpatients. Thorax. 2013 May;68(5):485-6. doi: 10.1136/thoraxjnl-2012-202484. Epub 2012 Sep 19.
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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.
Brian J Smith, MBBS; FRACP;PhD;Dip Clin Epid principal investigator
The Queen Elizabeth Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Champix and Counselling alone in people with Tobacco Use Disorder, run by The Queen Elizabeth Hospital at 3 sites in Australia.
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 6 inclusion and 7 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 8 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 abstinence (time frame: one year). 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 NCT01141855, 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 8 Aug 2012.