Smoking Termination Opportunity for inPatients

Tobacco Use Disorder Clinical Trial

— STOP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01141855
• Other study ID #: 2008012
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 10, 2010
• Last updated: August 7, 2012
• Start date: May 2008
• Est. completion date: December 2011

Study information

• Verified date: April 2010
• Source: The Queen Elizabeth Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 392
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

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)

Behavioral:
• Counselling alone
Quit SA 5A counselling over the phone. Maximum 8 calls over a 3 month period

Locations

Country	Name	City	State
Australia	Lyell McEwin Health Service	Adelaide	South Australia
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	The Queen Elizabeth Hospital	Adelaide	South Australia

Sponsors (1)

Lead Sponsor	Collaborator
The Queen Elizabeth Hospital

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	7-day point prevalence	Defined as no cigarettes for the previous 7 days	from 2 weeks to 3 months post enrollment	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	Yes