Clinical trial NCT01141855: Smoking Termination Opportunity for inPatients
Official title: Effectiveness of Inpatient Initiated Varenicline Tartrate for Smoking Cessation, for Smoking Related Illnesses.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Tobacco Use Disorder
Keywords: Cardiovascular Diseases
Peripheral Vascular Diseases
Cerebrovascular Stroke
Lung Diseases, Obstructive
Asthma
Tobacco Use Disorder
Smoking
Smoking Cessation
Lead sponsor: The Queen Elizabeth Hospital
Sponsor class: OTHER
First posted: 2010-06-11
Enrollment: 392
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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 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:

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Smoking abstinence
timeFrame: one year
Secondary outcomes:
measure: Reduced hospital bed utilisation
timeFrame: one year
measure: 7-day point prevalence
timeFrame: from 2 weeks to 3 months post enrollment
measure: Reduction in health care costs
timeFrame: one year
measure: Inpatient craving levels
timeFrame: baseline to end of inpatient stay
measure: Prevalence of inpatient smoking
timeFrame: From baseline to end of inpatient stay
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Adelaide
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Adelaide
country: Australia
facility: Lyell McEwin Health Service
state: South Australia
Study officials:
affiliation: The Queen Elizabeth Hospital
name: Brian J Smith, MBBS; FRACP;PhD;Dip Clin Epid
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.