Not Yet RecruitingPhase 4ACTRN12609000270213

An open trial of a Cognitive Behavioural Therapy (CBT)-based smoking cessation plus Varenicline intervention in people with a psychotic disorder


Sponsor

Pfizer Australia (Investigator Initiated Grant)

Enrollment

15 participants

Start Date

May 1, 2009

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests a smoking cessation program combining talk therapy (CBT) with a medication called varenicline for adults (18+) who have a psychotic disorder such as schizophrenia or bipolar disorder and smoke heavily (at least 15 cigarettes per day). Participants must be on stable psychiatric medication for at least 3 months.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 session

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.


Locations(1)

Australia

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ACTRN12609000270213