Smoking Termination Opportunity for inPatients (STOP)

This study has been completed.
Sponsor:
Information provided by:
The Queen Elizabeth Hospital
ClinicalTrials.gov Identifier:
NCT01141855
First received: June 10, 2010
Last updated: August 7, 2012
Last verified: April 2010
  Purpose

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 Intervention Phase
Tobacco Use Disorder
Drug: Champix
Behavioral: Counselling alone
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Effectiveness of Inpatient Initiated Varenicline Tartrate for Smoking Cessation, for Smoking Related Illnesses.

Resource links provided by NLM:


Further study details as provided by The Queen Elizabeth Hospital:

Primary Outcome Measures:
  • Smoking abstinence [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: one year ] [ Designated as safety issue: No ]
    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 [ Time Frame: from 2 weeks to 3 months post enrollment ] [ Designated as safety issue: Yes ]
    Defined as no cigarettes for the previous 7 days

  • Reduction in health care costs [ Time Frame: one year ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline to end of inpatient stay ] [ Designated as safety issue: No ]
    Craving scales will be used to assess levels during inpatient stay (pre and post intervention delivery)

  • Prevalence of inpatient smoking [ Time Frame: From baseline to end of inpatient stay ] [ Designated as safety issue: Yes ]
    Measured by self-report and observation by hospital and study staff prior to discharge.


Enrollment: 392
Study Start Date: May 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01141855

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

No publications provided by The Queen Elizabeth Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Associate Professor Brian James Smith, The Queen Elizabeth Hospital
ClinicalTrials.gov Identifier: NCT01141855     History of Changes
Other Study ID Numbers: 2008012
Study First Received: June 10, 2010
Last Updated: August 7, 2012
Health Authority: Australia: Human Research Ethics Committee

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

Additional relevant MeSH terms:
Smoking
Tobacco Use Disorder
Habits
Substance-Related Disorders
Mental Disorders
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2014