Smoking Termination Opportunity for inPatients (STOP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01141855
Recruitment Status : Completed
First Posted : June 11, 2010
Last Update Posted : August 8, 2012
Information provided by:
The Queen Elizabeth Hospital

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

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Drug: Champix Behavioral: Counselling alone Phase 2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 392 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Effectiveness of Inpatient Initiated Varenicline Tartrate for Smoking Cessation, for Smoking Related Illnesses.
Study Start Date : May 2008
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: 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
Drug: 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)

Other Names:
  • varenicline tartrate
  • Chantix

Active Comparator: counselling alone
5A counselling via Quit SA (quitline) telephone counselling service. (maximum 8 phone calls per subject within a 3 month period).
Behavioral: Counselling alone
Quit SA 5A counselling over the phone. Maximum 8 calls over a 3 month period
Other Name: Quitline counselling service

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01141855

Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
The Queen Elizabeth Hospital
Adelaide, South Australia, Australia, 5011
Lyell McEwin Health Service
Adelaide, South Australia, Australia, 5112
Sponsors and Collaborators
The Queen Elizabeth Hospital
Principal Investigator: Brian J Smith, MBBS; FRACP;PhD;Dip Clin Epid The Queen Elizabeth Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Associate Professor Brian James Smith, The Queen Elizabeth Hospital Identifier: NCT01141855     History of Changes
Other Study ID Numbers: 2008012
First Posted: June 11, 2010    Key Record Dates
Last Update Posted: August 8, 2012
Last Verified: April 2010

Keywords provided by The Queen Elizabeth Hospital:
Cardiovascular Diseases
Peripheral Vascular Diseases
Cerebrovascular Stroke
Lung Diseases, Obstructive
Tobacco Use Disorder
Smoking Cessation

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs