Smoking Termination Opportunity for inPatients (STOP)

The Queen Elizabeth Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Tobacco Use Disorder

Treatments: Drug: Champix; Behavioral: Counselling alone

Study type: Interventional

Funder types: Other

Identifiers

NCT01141855

2008012

Details and patient eligibility

About

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

Full 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.

Enrollment: 392 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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392 participants in 2 patient groups

Champix plus counselling

Experimental group

Description:

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

Treatment:

Drug: Champix

counselling alone

Active Comparator group

Description:

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

Treatment:

Behavioral: Counselling alone