None listed
Conditions
Brief summary
Rates of smoking are very high (>70%) amongst people with psychotic disorders such as schizophrenia, and this contributes to overall cardiovascular disease and other health risk, and contributes to premature morbidity. Current treatments targeting smoking in this group have had unsatisfactory outcomes, leaving a major gap in service provision. This study aims to evaluate a validated cognitive-behavioural smoking cessation intervention together with Varenicline, a novel smoking cessation medication. Given that this agent has the potential to have psychiatric side effects in people with a predisposition to mental illness, comprehensive safety checks will be put in place to ensure safety of participants.
Interventions
An open trial of a CBT-based intervention for smoking, in conjunction with varenicline. The Intervention:
(a) The non-pharmacological component: The intervention will consist of 6 once-weekly sessions of Cognitive Behavioural Therapy (CBT) of 1-hour duration, followed by three 1-hour booster sessions at weeks 8 and 10 and 12. Treatment will be delivered according to our treatment manual. Specific components of therapy include: case formulation and feedback from assessment, psychoeducation, motiv
An open trial of a CBT-based intervention for smoking, in conjunction with varenicline. The Intervention: (a) The non-pharmacological component: The intervention will consist of 6 once-weekly sessions of Cognitive Behavioural Therapy (CBT) of 1-hour duration, followed by three 1-hour booster sessions at weeks 8 and 10 and 12. Treatment will be delivered according to our treatment manual. Specific components of therapy include: case formulation and feedback from assessment, psychoeducation, motivation enhancement, mood/craving monitoring, mindfulness training, cognitive restructuring (identifying and managing unhelpful automatic thought patterns), enhancement of non-smoking related activities, pleasant events scheduling, coping with cravings (cigarettes), problem-solving, schema change methods, refusal skills and relapse prevention and/or management. During each therapy session, discussion and skills practice will focus on the particular unhealthy behaviours identified as most important/problematic by the participant. Opportunities will be taken by the therapists to integrate messages/skill development about other lifestyle factors as appropriate. Self-help material is provided throughout the treatment period, according to the unhealthy lifestyle behaviour being discussed in the session. (b) The pharmacological component: Varenicline will be provided to participants at each visit. Dose titration will follow that adopted by Gonzalez and colleagues (2006) and as outlined in the Monthly Index of Medical Specialties (MIMS) Australia (Oct/Nov 2008), viz.: 0.5mg daily for days 1-3; 1mg daily for days 4-7, and 1mg twice daily (the target dose) from days 8 to 84. The dose is administered by oral tablets.
Sponsors
Pfizer Australia (Investigator Initiated Grant)
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed