An open trial of a Cognitive Behavioural Therapy (CBT)-based smoking cessation plus Varenicline intervention in people with a psychotic disorder
Phase 4
- Conditions
- Smoking cessation in people with a psychotic illness.Mental Health - SchizophreniaMental Health - AddictionMental Health - Psychosis and personality disorders
- Registration Number
- ACTRN12609000270213
- Lead Sponsor
- Pfizer Australia (Investigator Initiated Grant)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
Aged 18 years and over; Diagnosis of a psychotic disorder (e.g. schizophrenia, schizoaffective disorder, bipolar disorder, etc.) and on stable psychiatric medication for at least three months; Current heavy smoker (at least 15 cigarettes per day).
Exclusion Criteria
(1) Non-psychotic illness; (2) People who are smoking fewer than 15 cigarettes per day; (3) Non-English speakers; (4) People with organic brain diseases; (4) An unstable psychiatric (eg., actively suicidal) or medical condition (eg., uncontrolled diabetes); (5) People with any specific contraindication to the use of varenicline; (6) Pregnant women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Smoking cessation. The outcome will be assessed using the following measures: 1. Opiate Treatment Index (OTI,) to estimate average daily use of tobacco during the month prior to assessment, point prevalence and continuous abstinence.<br>2. Readiness and Motivation to Quit Smoking Questionnaire (Crittenden et al., 1994).<br>3. The Fagerstom Test for Nicotine Dependence (FTND) (Fagerstrom et al, 1996).<br>4. Breath levels of carbon monoxide will be measured using a Micro 11 Smokerlyser.<br>5. The Minnesota Nicotine Withdrawal Scale Revised (self and observer rating).[At baseline, post 12 week intervention and 3 months thereafter.]
- Secondary Outcome Measures
Name Time Method