Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12606000133538
Ethics application status
Approved
Date submitted
5/04/2006
Date registered
13/04/2006
Date last updated
13/04/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Freedom from Smoking Clinical Trial
Scientific title
To establish from the data analysis of nicotine addicted trial participants, whether or not a permanent behavioural shift can occur as a result of undertaking the Freedom from Smoking Programme.
Universal Trial Number (UTN)
Trial acronym
FFS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Drug addiction / substance abuse, primarily nicotine 1101 0
Condition category
Condition code
Mental Health 1180 1180 0 0
Addiction

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
To establish from the data analysis of trial participants, whether or not a permanent behavioural shift from addiction can occur as a result of undertking the Freedom From Smoking Programme for 2 - 4 weeks. The study assessment period for each patient (participant) is 2 years. Measurements will be made at the beginning of the programme, at 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 12 months, 18 months and 2 years.
Intervention code [1] 971 0
Rehabilitation
Comparator / control treatment
No comparator.
Control group

Outcomes
Primary outcome [1] 1593 0
To free people worldwide from harmful addictions, primarily nicotine at this stage.
Timepoint [1] 1593 0
The time point is 2 - 4 weeks direct intervention time.
Secondary outcome [1] 2884 0
To prove that successful outcomes can occur through the healing of the psychological cause of addiction and that patients can remain addiction free within time frames of reassessment over a 2 year period.
Timepoint [1] 2884 0
At time intervals to assess measurable outcomes at 3, 6, 12, 18 months.
Secondary outcome [2] 2885 0
The Freedom from Smoking programme is a successful medium to achieve this outcome.
Timepoint [2] 2885 0
The time point is 2 years.

Eligibility
Key inclusion criteria
Minimum age
14 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Case control
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1291 0
Charities/Societies/Foundations
Name [1] 1291 0
Freedom Team Foundation Inc.
Country [1] 1291 0
Primary sponsor type
Charities/Societies/Foundations
Name
Freedom Team Foundation Inc. No A0039188D
Address
Country
Secondary sponsor category [1] 1141 0
None
Name [1] 1141 0
Nil
Address [1] 1141 0
Country [1] 1141 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2622 0
Committee of Management Freedom Team Foundation Inc
Ethics committee address [1] 2622 0
Ethics committee country [1] 2622 0
Australia
Date submitted for ethics approval [1] 2622 0
Approval date [1] 2622 0
28/03/2006
Ethics approval number [1] 2622 0
FFSCT001

Summary
Brief summary
To participate in a 14 day, self help programme consisting of a 99 page manual, 2 CD's and workbook with optional teaching if required. A confidential, in depth trial questionnaire to be answered by the participant in order to interpret and analyse the success or otherwise of the programme, taking into account individual criterion of each participant.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35157 0
Address 35157 0
Country 35157 0
Phone 35157 0
Fax 35157 0
Email 35157 0
Contact person for public queries
Name 10160 0
Janet Wadge
Address 10160 0
Freedom Team Foundation Inc
3/24 Dickens Street
Glen Iris VIC 3146
Country 10160 0
Australia
Phone 10160 0
+61 3 98896031
Fax 10160 0
+61 3 98896031
Email 10160 0
[email protected]
Contact person for scientific queries
Name 1088 0
Adriana James-Richard
Address 1088 0
Freedom Team Foundation Inc
PO Box 186
Ashburton VIC 3147
Country 1088 0
Australia
Phone 1088 0
+61 3 98899728
Fax 1088 0
+61 3 98896031
Email 1088 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.