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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 information initially 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
Swinburne University of Technology
P O Box 218
Hawthorn
VIC 3122
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
Only few studies have examined the use of Hypericum perforatum (HP) to assist in smoking cessation. In an animal study HP has been shown to decrease symptoms associated with smoking cessation. Research on humans has found preliminary evidence to suggest that HP increases long term abstinence rates and decreases anxiety. The proposed trial will expand on these animal and small human trials by conducting a randomized, open human trial with the following treatment arms; 1) HP extract (Remotiv; Ze117); 2) nicotine patches and a combination of Remotiv/nicotine patches treatments.

The proposed study will provide scientifically valid data to date on whether HP is effective either alone or in combination with nicotine patches to help smokers quite smoking.
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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Stough, Con, Andrew Scholey, Christina Kure, Joann... [More Details]
Study results articleYes Camfield, D. A., et al. "The neurocognitive effect... [More Details]

Documents added automatically
No additional documents have been identified.