None listed
Conditions
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.
Interventions
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. Do
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.
Sponsors
Swinburne University of Technology
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Exclusion criteria
History of anxiety or depression; currently using nicotine replacement therapy; kidney or liver disease; high blood pressure; diabetes
Outcome results
None listed