Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000050358
Ethics application status
Approved
Date submitted
30/11/2007
Date registered
29/01/2008
Date last updated
3/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A double blind randomized controlled trial to investigate laser acupuncture treatment for smoking cessation.
Scientific title
A double blind randomized controlled trial to investigate laser and sham laser on auricular and body acupuncture points to assist in smoking cessation
Secondary ID [1] 262973 0
UTS HREC 2007-151A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking cessation 2599 0
Condition category
Condition code
Alternative and Complementary Medicine 2713 2713 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Laser treatment will be given four times in the first two weeks of the quit attempt. Treatment will be given on acupuncture points on the ears, wrists and hands. Each point will be treated for one minute. Treatment will consist of a single diode laser with the following irradiation parameters: power output: 50mW; wavelength: 820nm; pulse repetition rate: 20HZ; radiant exposure: 24Jcm.
Intervention code [1] 2332 0
Treatment: Other
Comparator / control treatment
Sham laser treatment will be given with a sham probe on the same points as received by the verum group.
Control group
Placebo

Outcomes
Primary outcome [1] 3609 0
Smoking cessation measured by self report of smoking cessation at six months and one biochemical test of Carbon monoxide [CO] [less than 10 p.p.m. in expired air] a at six months from initial quit attempt
Timepoint [1] 3609 0
The primary outcome will be measured at 26 weeks from commencement of treatment.
Secondary outcome [1] 6046 0
Smoking cessation at 12 weeks as indicated by self report of smoking cessation and one biochemical test of Carbon Monoxide , less than 10 p.p.m.in expired air.
Timepoint [1] 6046 0
Note that with smoking cessation the long term outcome of smoking cessation at 26 weeks or 6 months is the most desired outcome [the Russell Standard 6 months-RS6], and smoking cessation at 12 weeks is secondary to that. Hence outcomes will be measured at 1, 2, 6, 12 weeks and 26 weeks from commencement of treatment.
Secondary outcome [2] 6048 0
Significant difference in the Wisconsin Smoking Withdrawal questionnaire between the sham and verum group.
Timepoint [2] 6048 0
As noted above, the primary outcome is smoking cessation at 6 months. Secondary outcomes are reduced withdrawal symptoms at 1,2,6 12 and 26 weeks, and significant changes in the questionnaires [which also will be measured at 1,2,6,12 and 26 weeks.
Secondary outcome [3] 6049 0
Significant difference between the laser and sham laser group on Minnesota Behaviour Self report questionnaire.
Timepoint [3] 6049 0
As noted above, the primary outcome is smoking cessation at 6 months. Secondary outcomes are reduced withdrawal symptoms at 1,2,6 12 and 26 weeks, and significant changes in the questionnaires [which also will be measured at 1,2,6,12 and 26 weeks.

Eligibility
Key inclusion criteria
Adults who are smokers. Adults who wish to give up smoking. Adults who can understand the consent form and agree to treatment and can read and write sufficiently to read and answer the questionnaires.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Adults who have uncontrolled diabetes mellitus, ischemic heart disease, unstable epilepsy or asthma or are pregnant.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
When interested volunteers have been informed of the trial procedures, had a chance to ask questions, signed the consent form, they will be allocated a number.

This number will be forwarded to central administrator who holds the allocation schedule. The subject will be randomly allocated to a particular group according to the random number table. The investigator will then be informed of this allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer genereated random number table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2847 0
University
Name [1] 2847 0
Faculty of Science
University of Technology, Sydney (UTS)
Country [1] 2847 0
Australia
Funding source category [2] 2848 0
Self funded/Unfunded
Name [2] 2848 0
Jenny Head
Country [2] 2848 0
Australia
Primary sponsor type
University
Name
Dr Christopher Zaslawski
Address
Director
UTS College of Traditional Chinese Medicine
Department of Medical and Molecular Bioscience
University of Technology Sydney (UTS)
Faculty of Science
Building 4 Level 3 Room 46B
Country
Australia
Secondary sponsor category [1] 2567 0
University
Name [1] 2567 0
Dr Deirdre Cobbin
Address [1] 2567 0
Department of Medical and Molecular Bioscience
Faculty of Science
University of Technology Sydney (UTS)
Building 4 Level 3 Room 42B
Country [1] 2567 0
Australia
Secondary sponsor category [2] 2568 0
Individual
Name [2] 2568 0
Jenny Head
Address [2] 2568 0
2A Union St, Bega, NSW 2550
Country [2] 2568 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4795 0
University of Technology Sydney, Human Research Ethics Committee
Ethics committee address [1] 4795 0
University of Technology, Sydney
Ultimo Sydney NSW
Ethics committee country [1] 4795 0
Australia
Date submitted for ethics approval [1] 4795 0
Approval date [1] 4795 0
16/10/2007
Ethics approval number [1] 4795 0
UTS HREC 2007-151A

Summary
Brief summary
The primary purpose of this study is to access the results of using laser acupuncture to assist long term smoking cessation. Long term smoking cessation is assessed at 26 weeks after treatment commences. This trial has attempted to remedy the deficiencies of a previous laser acupuncture trials. It has been designed to address several questions: 1. Does true [verum] laser acupuncture have better outcomes of smoking cessation than sham laser acupuncture ? This style of laser acupuncture treatment has been chosen because there is not enough evidence from trials of this type of treatment to assess its validity. The Cochrane Library Review, Acupuncture and Related Interventions for Smoking Cessation [White, Rampes et al, 2007] was updated in 2007 and stated that “there is no consistent evidence that acupuncture, acupressure, laser therapy or electro-stimulation are effective for smoking cessation, but methodological problems mean that no firm conclusions can be drawn.” Research has shown acupuncture is a safe therapy with few side effects. Using the drug therapy of nicotine replacement therapy and Bupropion therapy as aids to assist smoking cessation is not suitable for everybody. The outcome of this trial will be clearer information about the role of true [verum] laser acupuncture This will inform recommendations for interventions that will assist smokers wishing to quit. It will add worthwhile information to the debate concerning the use of acupuncture and may influence future meta-analysis and reviews concerning the efficacy of laser acupuncture treatment and its role in assisting people to cease smoking.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28223 0
Address 28223 0
Country 28223 0
Phone 28223 0
Fax 28223 0
Email 28223 0
Contact person for public queries
Name 11380 0
Jenny Head
Address 11380 0
2A Union St, Bega, NSW 2550
Country 11380 0
Australia
Phone 11380 0
0466 245 623
Fax 11380 0
Email 11380 0
[email protected]
Contact person for scientific queries
Name 2308 0
Dr Chris Zaslawski
Address 2308 0
University of Technology Sydney, Faculty of Science, Building 4 level 3.46B
Country 2308 0
Australia
Phone 2308 0
02 9714 7856
Fax 2308 0
Email 2308 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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