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Tobacco CessationNCT00971529

Smoking Cessation Effect of Tea Filter Through Inhibition of Nicotine Receptor

An observational study of Tobacco Cessation, run by General Hospital of Beijing PLA Military Region at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Cigarette smoking is the major risk factor for a series of life threatening diseases including cancer and heart attack, which causes millions of deaths each year worldwide. Many of the harmful effects of cigarette smoking can be reversed by quitting; however, due to the addictive nature of nicotine, quitting smoking… Read more about this study

Who is it for?
Ages 18 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Tobacco Cessation
How many people
159 participants
Where
1 siteChina
Study dates
Jan 2009to Jul 2009
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: 70 volunteers were double-blinded, placebo-controlled and randomized into 2 groups (smoking with tea filters or regular filters). The investigators then recruited 59 volunteers with longer smoking history and stronger desire for quitting smoking for smoking cessation test using the tea filter.

Who may be able to join

  • Healthy male cigarette smokers, aged 18 to 65 years

Who cannot join

  • Exclusion criteria included treatment with an investigational drug within the previous month
  • Major depression within the prior year
  • Panic disorder
  • Psychosis
  • Bipolar disorder
  • Use of nicotine replacement therapy or other drugs within the previous 3 months
Show all 10Show fewer
  • Cardiovascular disease
  • Clinically significant medical disease
  • Drug or alcohol abuse or dependence within the past year
  • Use of tobacco products other than cigarette smoking within the previous month.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Ran Tao

    Beijing, 100700

Other trials in China

About this study

Official title: Phase 1 Study on Smoking Cessation Effect of Tea Filter

Cigarette smoking is the major risk factor for a series of life threatening diseases including cancer and heart attack, which causes millions of deaths each year worldwide. Many of the harmful effects of cigarette smoking can be reversed by quitting; however, due to the addictive nature of nicotine, quitting smoking is extremely difficult. Despite the efforts, currently available methods produce only modest smoking cessation rates with relapse. Previously, tea components were shown to protect effect against cigarette smoke-induced toxicity. Here the investigator reported an unprecedented smoking cessation effect of tea. Green tea was made into cigarette filters and tested for its smoking cessation effect in a double-blind clinical study. The tea filter could effectively achieve abstinence relapse using smoking process to quite smoking and easy to be used by smoker without any side effects and psychological obstacles. This work provides a new idea and innovative method to combat tobacco epidemic. Its implementation and popularization may make a great contribution towards to reducing the smoking-related diseases, and relieving the public health burden and pollution caused by cigarette smoking.

Read the detailed description

Cigarette smoking has been linked to many life threatening diseases including heart diseases, cancer and chronic obstructive pulmonary disease. There are about 1.25 billion smokers in the world. Five million people die every year because of smoking-related diseases. This rate exceeds many other diseases combined. It is estimated that the global cost for smoking-related diseases is about $200 billion each year, posing one of the biggest public human health problems around the world. Many methods have been developed for smoking cessation by scientists and doctors worldwide. However, due to the addictive nature of nicotine, quitting smoking is extremely difficult. Despite all the efforts, currently available smoking cessation methods produce only modest successful rates with relapse. In addition, they are often not convenient and can lead to a wide variety of side effects. Therefore, the need of new idea for developing new smoking cessation techniques with better efficacy and fewer side effects is urgent.

Epidemiological evidences have shown that tea is adversely associated with cancer, hyperglycemia and other diseases. In addition, we have shown that tea components protect cells from cigarette smoke-induced toxicity. Recently, we have developed a new cigarette filter containing tea. While testing the filter for detoxification effects, we found that several subjects who were smokers decreased their cigarette consumption and subsequently abstained from cigarette smoking after using the tea filter for a period of time. Animal experiments revealed that a derivative tea component prevented nicotine addiction similar to nicotine acetylcholine receptor (nAChR) inhibitor. It significantly inhibited the nicotine-induced expression of alpha4,alpha7 and β2 subunits of nAChR and tyrosine hydroxylase and release of dopamine. This finding encouraged us to recruit more volunteers to test the smoking cessation effect of the tea filter.

One hundred healthy male cigarette smokers, aged 18 to 30 years, were screened and 30 of them were excluded based on the exclusion/inclusion criteria. 70 volunteers were double-blinded, placebo-controlled and randomized into 2 groups (smoking with tea filters or regular filters). Smoking history, including the nicotine dependence, was assessed at the screening visit. Exclusion criteria included treatment with an investigational drug within the previous month; major depression within the prior year; panic disorder, psychosis, or bipolar disorder; use of nicotine replacement therapy or other drugs within the previous 3 months; cardiovascular disease; clinically significant medical disease; drug or alcohol abuse or dependence within the past year; and use of tobacco products other than cigarette smoking within the previous month. Subjects received brief smoking cessation counseling (up to 10 minutes) at the baseline visit and at each visit afterwards. Self-reported smoking status since the last visit and exhaled carbon monoxide measurement were assessed at each weekly visit. Vital signs, weight, and adverse event information were collected at each visit. A physical examination was performed prior to randomization and at the final visit. Urine and blood were collected at screening, baseline, and at weeks 1, 2, 3, and 4 for biochemical analysis.

The average number of cigarettes consumed daily by one volunteer smoker before the clinic trial was calculated as control. The average number of cigarettes consumed daily by one volunteer after the clinic trial was calculated and the numbers were then used to calculate the averages number of cigarettes consumed daily by one smoker in a week and compared with control. Continuous abstinence was defined as self-report of no cigarette use during the specified time period confirmed by an exhaled carbon monoxide measurement of 10 ppm or lower. To be considered abstinent from smoking during the treatment period, subjects also had to report that they did not use any other nicotine-containing products. During the follow-up period, use of nicotine replacement therapy did not disqualify subjects from being considered abstinent. Subjects who withdrew or were lost to follow-up were assumed to be smokers for the remainder of the study. The exhaled carbon monoxide was detected by a carbon monoxidemeter (1209-1 CO, DWYER, USA). Nicotine and cotinine in urine was detected using HPLC (HITACH, Japan) as reported in the literature.

30 volunteers in control group and 22 volunteer male cigarette smokers who consumed on average approximately cigarettes per day, were randomly divided into 2 groups (double-blind, placebo-controlled); smoking with tea filters or with regular filters. After using the tea filter for 1 month, the average daily cigarette consumption decreased about 43% in the tea filter group. In contrast, no change in average daily cigarette consumption was detected in the control group using regular filters. The trial was discontinued for the control group and the tea filter group was followed for another month. After using the tea filter for 2 months.

We then recruited 59 volunteers with longer smoking history and stronger desire for quitting smoking for smoking cessation test using the tea filter. The subjects were followed for 5 month following the same protocol as described earlier.

Keywords
Smoking cessation, tea filter
Medical subject headings
Tobacco Use Cessation, Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00971529
Study groupRoleWhat they receive
lifestyle70 volunteers were double-blinded, placebo-controlled and randomized into 2 groups (smoking with tea filters or regular filters).
tea filterThe investigators then recruited 59 volunteers with longer smoking history and stronger desire for quitting smoking for smoking cessation test using the tea filter.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. number of cigarettes consumed daily by every volunteer smoker

    Measured: 1-5 months

Secondary outcomes (1)
  1. exhaled carbon monoxide by the volunteers

    Measured: in the evening

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2009 (estimated)
  2. Study startJan 2009
  3. Primary completionMay 2009
  4. Study completionJul 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Enrolment
159 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00971529
Sponsor's protocol ID
zhaotaoliang123
Status last verified
Sep 2009
First submitted
20 Aug 2009
Last updated
4 Sep 2009
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Tobacco Cessation, run by General Hospital of Beijing PLA Military Region at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

number of cigarettes consumed daily by every volunteer smoker (time frame: 1-5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2009; AzTrials last refreshed its copy on 8 Nov 2026.

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