search
Back to results

Smoking Termination Opportunity for inPatients (STOP)

Primary Purpose

Tobacco Use Disorder

Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Champix
Counselling alone
Sponsored by
The Queen Elizabeth Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tobacco Use Disorder focused on measuring Cardiovascular Diseases, Peripheral Vascular Diseases, Cerebrovascular Stroke, Lung Diseases, Obstructive, Asthma, Tobacco Use Disorder, Smoking, Smoking Cessation

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Adelaide Hospital
  • The Queen Elizabeth Hospital
  • Lyell McEwin Health Service

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Champix plus counselling

counselling alone

Arm Description

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

5A counselling via Quit SA (quitline) telephone counselling service. (maximum 8 phone calls per subject within a 3 month period).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
7-day point prevalence
Defined as no cigarettes for the previous 7 days
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.
Inpatient craving levels
Craving scales will be used to assess levels during inpatient stay (pre and post intervention delivery)
Prevalence of inpatient smoking
Measured by self-report and observation by hospital and study staff prior to discharge.

Full Information

First Posted
June 10, 2010
Last Updated
August 7, 2012
Sponsor
The Queen Elizabeth Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01141855
Brief Title
Smoking Termination Opportunity for inPatients
Acronym
STOP
Official Title
Effectiveness of Inpatient Initiated Varenicline Tartrate for Smoking Cessation, for Smoking Related Illnesses.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The Queen Elizabeth Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
Keywords
Cardiovascular Diseases, Peripheral Vascular Diseases, Cerebrovascular Stroke, Lung Diseases, Obstructive, Asthma, Tobacco Use Disorder, Smoking, Smoking Cessation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
392 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Champix plus counselling
Arm Type
Experimental
Arm Description
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
Arm Title
counselling alone
Arm Type
Active Comparator
Arm Description
5A counselling via Quit SA (quitline) telephone counselling service. (maximum 8 phone calls per subject within a 3 month period).
Intervention Type
Drug
Intervention Name(s)
Champix
Other Intervention Name(s)
varenicline tartrate, Chantix
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Counselling alone
Other Intervention Name(s)
Quitline counselling service
Intervention Description
Quit SA 5A counselling over the phone. Maximum 8 calls over a 3 month period
Primary Outcome Measure Information:
Title
Smoking abstinence
Description
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.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Reduced hospital bed utilisation
Description
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.
Time Frame
one year
Title
7-day point prevalence
Description
Defined as no cigarettes for the previous 7 days
Time Frame
from 2 weeks to 3 months post enrollment
Title
Reduction in health care costs
Description
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.
Time Frame
one year
Title
Inpatient craving levels
Description
Craving scales will be used to assess levels during inpatient stay (pre and post intervention delivery)
Time Frame
baseline to end of inpatient stay
Title
Prevalence of inpatient smoking
Description
Measured by self-report and observation by hospital and study staff prior to discharge.
Time Frame
From baseline to end of inpatient stay

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian J Smith, MBBS; FRACP;PhD;Dip Clin Epid
Organizational Affiliation
The Queen Elizabeth Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
The Queen Elizabeth Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Lyell McEwin Health Service
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5112
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
22993168
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.
Results Reference
derived

Learn more about this trial

Smoking Termination Opportunity for inPatients

We'll reach out to this number within 24 hrs