Smoking Termination Opportunity for inPatients (STOP)

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

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

Study Overview

• Status: Completed
• Conditions: Tobacco Use Disorder
• Intervention / Treatment: Drug: Champix; Behavioral: Counselling alone

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
• Enrollment (Actual): 392
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital
    • Adelaide, South Australia, Australia, 5011
      • The Queen Elizabeth Hospital
    • Adelaide, South Australia, Australia, 5112
      • Lyell McEwin Health Service

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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: Chantix; varenicline tartrate
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 Names: Quitline counselling service

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking abstinence	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.	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduced hospital bed utilisation	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.	one year
7-day point prevalence	Defined as no cigarettes for the previous 7 days	from 2 weeks to 3 months post enrollment
Reduction in health care costs	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.	one year
Inpatient craving levels	Craving scales will be used to assess levels during inpatient stay (pre and post intervention delivery)	baseline to end of inpatient stay
Prevalence of inpatient smoking	Measured by self-report and observation by hospital and study staff prior to discharge.	From baseline to end of inpatient stay

Collaborators and Investigators

• Sponsor: The Queen Elizabeth Hospital
• Investigators: Principal Investigator: Brian J Smith, MBBS; FRACP;PhD;Dip Clin Epid, The Queen Elizabeth Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: June 10, 2010
• First Submitted That Met QC Criteria: June 10, 2010
• First Posted (Estimate): June 11, 2010

Study Record Updates

• Last Update Posted (Estimate): August 8, 2012
• Last Update Submitted That Met QC Criteria: August 7, 2012
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Keywords: Asthma; Lung Diseases, Obstructive; Cardiovascular Diseases; Smoking; Smoking Cessation; Tobacco Use Disorder; Cerebrovascular Stroke; Peripheral Vascular Diseases
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Nicotinic Agonists; Cholinergic Agonists; Varenicline
• Other Study ID Numbers: 2008012