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Smoking Termination Opportunity for inPatients

Effectiveness of Inpatient Initiated Varenicline Tartrate for Smoking Cessation, for Smoking Related Illnesses.

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01141855
Acronym
STOP
Enrollment
392
Registered
2010-06-11
Start date
2008-05-31
Completion date
2011-12-31
Last updated
2012-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Use Disorder

Keywords

Cardiovascular Diseases, Peripheral Vascular Diseases, Cerebrovascular Stroke, Lung Diseases, Obstructive, Asthma, Tobacco Use Disorder, Smoking, Smoking Cessation

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.

Interventions

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)

BEHAVIORALCounselling alone

Quit SA 5A counselling over the phone. Maximum 8 calls over a 3 month period

Sponsors

The Queen Elizabeth Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Smoking abstinenceone yearContinued 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.

Secondary

MeasureTime frameDescription
Reduced hospital bed utilisationone yearHospital 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.
7-day point prevalencefrom 2 weeks to 3 months post enrollmentDefined as no cigarettes for the previous 7 days
Reduction in health care costsone yearReduced 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.
Inpatient craving levelsbaseline to end of inpatient stayCraving scales will be used to assess levels during inpatient stay (pre and post intervention delivery)
Prevalence of inpatient smokingFrom baseline to end of inpatient stayMeasured by self-report and observation by hospital and study staff prior to discharge.

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026