Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
392 participants
INTERVENTIONAL
2008-05-31
2011-12-31
Brief Summary
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* 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
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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:
1. the smoker is a "captive audience" and may be receptive to considering lifestyle factors that have lead to the admission, and
2. 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
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
SINGLE
Study Groups
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Champix plus counselling
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
Champix
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 alone
5A counselling via Quit SA (quitline) telephone counselling service. (maximum 8 phone calls per subject within a 3 month period).
Counselling alone
Quit SA 5A counselling over the phone. Maximum 8 calls over a 3 month period
Interventions
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Champix
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 alone
Quit SA 5A counselling over the phone. Maximum 8 calls over a 3 month period
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
20 Years
75 Years
ALL
No
Sponsors
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The Queen Elizabeth Hospital
OTHER
Responsible Party
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The Queen Elizabeth Hospital
Principal Investigators
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Brian J Smith, MBBS; FRACP;PhD;Dip Clin Epid
Role: PRINCIPAL_INVESTIGATOR
The Queen Elizabeth Hospital
Locations
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Royal Adelaide Hospital
Adelaide, South Australia, Australia
The Queen Elizabeth Hospital
Adelaide, South Australia, Australia
Lyell McEwin Health Service
Adelaide, South Australia, Australia
Countries
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References
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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.
Other Identifiers
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2008012
Identifier Type: -
Identifier Source: org_study_id