NCT00971529

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2009

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 3, 2009

Completed
Last Updated

September 4, 2009

Status Verified

September 1, 2009

Enrollment Period

4 months

First QC Date

August 20, 2009

Last Update Submit

September 3, 2009

Conditions

Keywords

Smoking cessationtea filter

Outcome Measures

Primary Outcomes (1)

  • number of cigarettes consumed daily by every volunteer smoker

    1-5 months

Secondary Outcomes (1)

  • exhaled carbon monoxide by the volunteers

    in the evening

Study Arms (2)

lifestyle

70 volunteers were double-blinded, placebo-controlled and randomized into 2 groups (smoking with tea filters or regular filters).

tea filter

The investigators then recruited 59 volunteers with longer smoking history and stronger desire for quitting smoking for smoking cessation test using the tea filter.

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Healthy male cigarette smokers, aged 18 to 65 years

You may not qualify if:

  • Major depression within the prior year
  • Panic disorder
  • Psychosis
  • 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
  • Use of tobacco products other than cigarette smoking within the previous month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ran Tao

Beijing, 100700, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

CO

MeSH Terms

Conditions

Tobacco Use CessationSmoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Ran Tao, MD

    Addiction Branch, Beijing Military Reneral Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 20, 2009

First Posted

September 3, 2009

Study Start

January 1, 2009

Primary Completion

May 1, 2009

Study Completion

July 1, 2009

Last Updated

September 4, 2009

Record last verified: 2009-09

Locations