Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000270213
Ethics application status
Not yet submitted
Date submitted
13/03/2009
Date registered
15/05/2009
Date last updated
6/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
An open trial of a Cognitive Behavioural Therapy (CBT)-based smoking cessation plus Varenicline intervention in people with a psychotic disorder
Scientific title
An open trial of a Cognitive Behavioural Therapy (CBT)-based smoking cessation plus Varenicline intervention in people with a psychotic disorder
Secondary ID [1] 828 0
N/A
Universal Trial Number (UTN)
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking cessation in people with a psychotic illness. 4463 0
Condition category
Condition code
Mental Health 4730 4730 0 0
Schizophrenia
Mental Health 4731 4731 0 0
Addiction
Mental Health 5003 5003 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 4206 0
Lifestyle
Intervention code [2] 4207 0
Treatment: Drugs
Intervention code [3] 4208 0
Treatment: Other
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5601 0
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.
2. Readiness and Motivation to Quit Smoking Questionnaire (Crittenden et al., 1994).
3. The Fagerstom Test for Nicotine Dependence (FTND) (Fagerstrom et al, 1996).
4. Breath levels of carbon monoxide will be measured using a Micro 11 Smokerlyser.
5. The Minnesota Nicotine Withdrawal Scale Revised (self and observer rating).
Timepoint [1] 5601 0
At baseline, post 12 week intervention and 3 months thereafter.
Secondary outcome [1] 9428 0
Quality of Life: This will be assessed using the abbreviated World Health Organisation Quality of Life Scale (WHOQOL-BREF). The WHOQOL-BREF is a self-report generic quality of life instrument which assesses quality of life across four domains, including physical health, psychological wellbeing, social relationships and the environment.
Timepoint [1] 9428 0
At baseline, post 12 week intervention and 3 months thereafter.
Secondary outcome [2] 9437 0
Psychiatric symptomatology will be assessed using the following measures:
1. Brief Psychiatric Rating Scale (BPRS) a well-validated measure of psychotic symptoms.
2. Beck Depression Inventory (BDI) a well validated self-report measure of depressed mood, with a specific item on suicidality.
3. The Young Mania Rating Scale (YMRS) a widely used and validated assessment of manic symptomatology.
Timepoint [2] 9437 0
At baseline, post 12 week intervention and 3 months thereafter.
Secondary outcome [3] 9438 0
General functioning will be assessed using the following measures:
1. Global Assessment of Functioning (GAF) clinician-rated indicator of general functioning.
2. The Medical Outcome Survey SF-12(Ware et al, 1995) - a 12-item measure of functional status relating to health.
Timepoint [3] 9438 0
At baseline, post 12 week intervention and 3 months thereafter.

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4654 0
Commercial sector/Industry
Name [1] 4654 0
Pfizer Australia (Investigator Initiated Grant)
Country [1] 4654 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Pfizer Australia (Investigator Initiated Grant)
Address
38-42 Wharf Road
West Ryde NSW 2114
Country
Australia
Secondary sponsor category [1] 4201 0
Hospital
Name [1] 4201 0
St.Vincent's Hospital
Address [1] 4201 0
PO Box 2900
Fitzroy Vic 3065
Country [1] 4201 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 6690 0
Human Research Ethics Committee-D (HREC-D)
Ethics committee address [1] 6690 0
Research and Grants Unit
St. Vincents Hospital
PO Box 2900
Fitzroy Vic 3065
Ethics committee country [1] 6690 0
Australia
Date submitted for ethics approval [1] 6690 0
18/02/2009
Approval date [1] 6690 0
22/04/2009
Ethics approval number [1] 6690 0
HREC-D 014/09

Summary
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.
Trial website
Trial related presentations / publications
Baker A, Richmond R, Castle D, Kulkarni J, Kay-Lambkin F, Sakrouge R, Filia S, Lewin TJ. “Coronary heart disease risk reduction intervention among overweight smokers with a psychotic disorder: a pilot trial”. Australian and New Zealand Journal of Psychiatry 2009; 43: 129-135
Public notes

Contacts
Principal investigator
Name 29385 0
Address 29385 0
Country 29385 0
Phone 29385 0
Fax 29385 0
Email 29385 0
Contact person for public queries
Name 12632 0
Prof. David Castle
Address 12632 0
St. Vincent's Hospital
PO Box 2900
Fitzroy Vic 3065
Country 12632 0
Australia
Phone 12632 0
+61 3 9288 4751
Fax 12632 0
+61 3 9288 4802
Email 12632 0
[email protected]
Contact person for scientific queries
Name 3560 0
Prof. David Castle
Address 3560 0
St. Vincent's Hospital
PO Box 2900
Fitzroy Vic 3065
Country 3560 0
Australia
Phone 3560 0
+61 3 9288 4751
Fax 3560 0
+61 3 9288 4802
Email 3560 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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