Smoking Termination Opportunity for inPatients

NCT01141855 | Completed Phase 2 DMC

• 1 other identifier: 2008012
• Study Type: interventional
• Target: 392
• Locations: 1 country
• Sites: 3

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

Conditions

Tobacco Use Disorder

Keywords

Cardiovascular Diseases; Peripheral Vascular Diseases; Cerebrovascular Stroke; Lung Diseases, Obstructive; Asthma; Tobacco Use Disorder; Smoking; Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Reduced hospital bed utilisation

  one year

• 7-day point prevalence

  from 2 weeks to 3 months post enrollment

• Reduction in health care costs

  one year

• Inpatient craving levels

  baseline to end of inpatient stay

• Prevalence of inpatient smoking

  From baseline to end of inpatient stay

Study Arms (2)

Champix plus counselling

EXPERIMENTAL

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

counselling alone

ACTIVE COMPARATOR

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

Behavioral: Counselling alone

Interventions

Champix DRUG

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)

Also known as: varenicline tartrate, Chantix

Champix plus counselling

Counselling alone BEHAVIORAL

Quit SA 5A counselling over the phone. Maximum 8 calls over a 3 month period

Also known as: Quitline counselling service

counselling alone

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Queen Elizabeth Hospital: lead

Study Sites (3)

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

The Queen Elizabeth Hospital

Adelaide, South Australia, 5011, Australia

Location

Lyell McEwin Health Service

Adelaide, South Australia, 5112, Australia

Location

Related Publications (1)

• 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.

  PMID: 22993168 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder; Cardiovascular Diseases; Peripheral Vascular Diseases; Stroke; Lung Diseases, Obstructive; Asthma; Smoking; Smoking Cessation

Interventions

Varenicline; Counseling

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Lung Diseases; Respiratory Tract Diseases; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Brian J Smith, MBBS; FRACP;PhD;Dip Clin Epid

  The Queen Elizabeth Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 10, 2010
• First Posted: June 11, 2010
• Study Start: May 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 8, 2012

Record last verified: 2010-04

Locations

AU (3)