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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
BEHAVIORAL - 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)

BEHAVIORAL: 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
BEHAVIORAL
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
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01141855