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OpenTrials
Completed

NCT Number: NCT01141855

Smoking Termination Opportunity for inPatients

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Champix

Drug

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)

Other names: varenicline tartrate, Chantix

Counselling alone

Behavioral

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

Other names: Quitline counselling service

Primary outcomes

  1. 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.

Secondary outcomes

  1. Reduced hospital bed utilisation

    Time frame: one year

    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.

  2. 7-day point prevalence

    Time frame: from 2 weeks to 3 months post enrollment

    Defined as no cigarettes for the previous 7 days

  3. Reduction in health care costs

    Time frame: one year

    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.

  4. Inpatient craving levels

    Time frame: baseline to end of inpatient stay

    Craving scales will be used to assess levels during inpatient stay (pre and post intervention delivery)

  5. Prevalence of inpatient smoking

    Time frame: From baseline to end of inpatient stay

    Measured by self-report and observation by hospital and study staff prior to discharge.

Sponsors and collaborators

Lead sponsor

The Queen Elizabeth Hospital

Other

Registry information

Official study title

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

Acronym: STOP

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jun 11, 2010
Registry last updated
Aug 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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