Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000500358
Ethics application status
Approved
Date submitted
11/08/2008
Date registered
30/09/2008
Date last updated
24/07/2020
Date data sharing statement initially provided
24/07/2020
Date results provided
24/07/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
The efficacy of Hypericum perforatum extract (Ze117), nicotine patches and combination Hypericum perforatum/nicotine patches for smoking cessation.
Scientific title
A clinical trial assessing the efficacy and neural mechanisms of Remotiv (Ze117), nicotine patches and combination Remotiv/nicotine patches for smoking cessation.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking 3534 0
Condition category
Condition code
Alternative and Complementary Medicine 3687 3687 0 0
Other alternative and complementary medicine
Alternative and Complementary Medicine 3920 3920 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are 3 treatment arms:

Group 1: Remotiv (250mg Ze117; standardised to 500mcg Hypericin).
Group 2: Nicabate CQ (Committed Quitters) Clear (Registered TradeMark)
Group 3: Remotiv (250mg Ze117; standardised to 500mcg Hypericin) and Nicabate CQ Clear (Registered TradeMark) combination

The Remotiv (Registered TradeMark) group will undertake a 4 week wash-in treatment period prior to the quit date in order to achieve therapeutic benefits from the herb. Remotiv will be administered orally. Dosage - 1 tablet 2 times a day for the first 12 weeks and then 1 tablet per day for 2 weeks (week 13 and 14).

Group 2: Nicabate CQ clear (Registered TradeMark) - individuals in this group will be asked to commence treatment on their quit date. NicabateCQ is an over the counter pharmacy medicine and treatment consists of a 10 week step down process consisting of a single transdermal patch delivery of the following doses of nicotine over a 24 hour period:

Step 1: 21mg nicotine per day for 6 weeks (weeks 1-6)
Step 2: 14mg of nicotine per day for 2 weeks (weeks 7&8)
Step 3: 7mg of nicotine per day for 2 weeks (weeks 9&10).

The nicotine patch is applied in the morning after a smoke free night to a clean, non-hairy site anywhere on the upper body or arm.

Group 3: Remotiv/Nicabate CQ(Registered TradeMark) combination – Participants will begin taking the Remotiv treatment 4 weeks before their quit date (as per group 1). On the quit date (4 weeks after the Remotiv wash-in period), participants will commence treatment with nicotine patches (as per group 2) and will continue taking the Remotiv treatment for another 10 weeks.
Intervention code [1] 3248 0
Treatment: Other
Comparator / control treatment
No treatment
Control group
Active

Outcomes
Primary outcome [1] 4596 0
Abstinence rates
Timepoint [1] 4596 0
4 weeks pre-quit, quit date, 6 and 10 weeks post quit
Secondary outcome [1] 7756 0
Patterns of brain activity will be measured using a technique called Steady State Topography (SST). This brain imaging technique is a non-invasive computerised tool. Small recording discs are placed on the scalp to measure brain function. A small quantity of a water-based conductive gel will be used to make electrical contact between the scalp surface and the recording discs. This will be washed-off once data collection has been completed. The application of recording discs does not involve any breaking or piercing of the skin. A pattern on a computer monitor will change while the participant concentrates on the centre of the pattern.
Timepoint [1] 7756 0
Baseline and 10 weeks post quit date

Eligibility
Key inclusion criteria
Smoking for at least 5 years; currently smoking at least 10 cigarettes per day;
Motivated to quit smoking; not currently (or in the past 6 months) taking Hypericum perforatum or anti-depressants
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of anxiety or depression; currently using nicotine replacement therapy; kidney or liver disease; high blood pressure; diabetes

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)
The treatment allocation was randomised by a researcher who is not directly involved in the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Latin square
Masking / blinding
Open (masking not 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
Completed
Date of first participant enrolment
Anticipated
23/06/2008
Actual
24/06/2008
Date of last participant enrolment
Anticipated
Actual
26/09/2008
Date of last data collection
Anticipated
Actual
14/12/2008
Sample size
Target
60
Accrual to date
Final
74
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3715 0
Commercial sector/Industry
Name [1] 3715 0
Flordis Herbal Medicines Ltd
Country [1] 3715 0
Australia
Primary sponsor type
University
Name
Swinburne University of Technology
Address
Swinburne University of Technology
Brain Sciences Institute
PO Box 218
Hawthorn
Vic 3122
Country
Australia
Secondary sponsor category [1] 3332 0
None
Name [1] 3332 0
Address [1] 3332 0
Country [1] 3332 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5770 0
Swinburne University Human Research Ethics Committee
Ethics committee address [1] 5770 0
Ethics committee country [1] 5770 0
Australia
Date submitted for ethics approval [1] 5770 0
Approval date [1] 5770 0
29/04/2008
Ethics approval number [1] 5770 0
0607/218

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28827 0
Address 28827 0
Country 28827 0
Phone 28827 0
Fax 28827 0
Email 28827 0
Contact person for public queries
Name 11984 0
Christina Kure
Address 11984 0
Swinburne University of Technology
P O Box 218
Hawthorn
Vic 3122
Country 11984 0
Australia
Phone 11984 0
+61 3 9214 4476
Fax 11984 0
+61 3 9214 5525
Email 11984 0
[email protected]
Contact person for scientific queries
Name 2912 0
Professor Con Stough
Address 2912 0
Swinburne University of Technology
Brain Sciences Institute
P O Box 218
Hawthorn
Vic 3122
Country 2912 0
Australia
Phone 2912 0
+61 3 9214 8167
Fax 2912 0
+61 3 9214 5525
Email 2912 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.