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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01141855




Registration number
NCT01141855
Ethics application status
Date submitted
10/06/2010
Date registered
11/06/2010
Date last updated
8/08/2012

Titles & IDs
Public title
Smoking Termination Opportunity for inPatients
Scientific title
Effectiveness of Inpatient Initiated Varenicline Tartrate for Smoking Cessation, for Smoking Related Illnesses.
Secondary ID [1] 0 0
2008012
Universal Trial Number (UTN)
Trial acronym
STOP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tobacco Use Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Addiction
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Champix
Behaviour - Counselling alone

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

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


Treatment: Drugs: 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)

Behaviour: Counselling alone
Quit SA 5A counselling over the phone. Maximum 8 calls over a 3 month period
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Smoking abstinence
Timepoint [1] 0 0
one year
Secondary outcome [1] 0 0
Reduced hospital bed utilisation
Timepoint [1] 0 0
one year
Secondary outcome [2] 0 0
7-day point prevalence
Timepoint [2] 0 0
from 2 weeks to 3 months post enrollment
Secondary outcome [3] 0 0
Reduction in health care costs
Timepoint [3] 0 0
one year
Secondary outcome [4] 0 0
Inpatient craving levels
Timepoint [4] 0 0
baseline to end of inpatient stay
Secondary outcome [5] 0 0
Prevalence of inpatient smoking
Timepoint [5] 0 0
From baseline to end of inpatient stay

Eligibility
Key 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
Minimum age
20 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Phase 2/Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2011
Sample size
Target
Accrual to date
Final
392
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
The Queen Elizabeth Hospital - Adelaide
Recruitment hospital [3] 0 0
Lyell McEwin Health Service - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
5011 - Adelaide
Recruitment postcode(s) [3] 0 0
5112 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
The Queen Elizabeth Hospital
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT01141855
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Brian J Smith, MBBS; FRACP;PhD;Dip Clin Epid
Address 0 0
The Queen Elizabeth Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01141855