- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01333202
Fresh Lime Alone for Smoking Cessation (LIM)
April 8, 2011 updated by: Thai Health Professional Alliance Against Tobacco
Efficacy of Fresh Lime Alone for Smoking Cessation
The purpose of this study is to determine whether fresh lime alone is effective for smoking cessation.
Study Overview
Detailed Description
Smoking is the major preventable cause of chronic medical diseases and death worldwide.
Significant efforts led by World Health Organization (WHO) and several countries have been made to help current smokers to quit, particularly in the developing countries, where their smoking rates continued to rise.
Clinical practice guidelines were therefore developed to guide all healthcare personnel in those countries to provide treatment for smokers.
However, despite that, only a small number of smokers were able to quit successfully.
A large number of smokers who are poor and heavily addicted to nicotine remain and have no access to any effective smoking cessation aids.
Although there are several effective medications available for smoking cessation nowadays, the high price of them completely keeps poor smokers away from using them.
Alternative and cheaper smoking cessation aids are therefore necessary.
During the past decade, certain herbal remedies have been introduced in smoking cessation in Thailand.
One of them that have been used widely without any supporting evidence is the fresh lime (Citrus aurantifolia), the well-known native citrus to Southeast Asia.
It is anecdotally claimed to be effective and safe in smoking cessation.
The present study was designed to determine the efficacy and safety of fresh lime as a smoking cessation aid compared with those of nicotine gum.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nondhaburi
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Plakred, Nondhaburi, Thailand, 11120
- Panyananthaphikkhu Chonprathan Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age over 18
- Smoked regularly at least one year prior to study entry
- Had the desire to quit smoking
- Signed informed consent
Exclusion Criteria:
- Having current dental problems
- Active peptic ulcer disease
- Psychiatric disorders
- Citrus allergy
- Pregnancy
- Use of illicit drugs
- Participation in another clinical trial and/or using any first-line smoking cessation aids within the past 30 days
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fresh lime
Those who were randomly assigned to receive fresh lime were instructed to use it every time they began to crave cigarettes and as often as they needed.
Fresh lime needed to be washed and cut into several small pieces by 1st cutting each lime into quarters and then each quarter further into 4 pieces.
When needed, subjects were told to suck each piece of lime and thereafter chew the lime skin.
To maintain freshness, the remaining slices were to be covered with plastic wrap and stored in the refrigerator as soon as possible.
All participants in this group had to report the number of fresh lime slices used per day in the self-report card.
|
fresh lime were used every time the participants began to crave cigarettes and as often as they needed.
To correctly use it, fresh lime needed to be washed and cut into several small pieces by 1st cutting each lime into quarters and then each quarter further into 4 pieces.
When needed, subjects were told to suck each piece of lime and thereafter chew the lime skin.
To maintain freshness, the remaining slices were to be covered with plastic wrap and stored in the refrigerator as soon as possible.
Other Names:
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Active Comparator: Nicotine gum
The dosage of nicotine gum used in this group was primarily based on the participants' FTND scores.
Those with FTND score of 4 or above were given 4-mg nicotine gum.
The 2-mg gum was assigned only to light smokers.
Appropriate gum use by "chew and park" technique was instructed to all subjects in this group.
They were advised to use the gum whenever they began to crave a cigarette but not to exceed more than 20 pieces per day.
All participants in this group also had to report the total number pieces of gum used per day in the self-report card.
Like the lime use group, phone calls were also made every 2-3 days during the initial month of study to remind them of technique and record keeping.
|
fresh lime were used every time the participants began to crave cigarettes and as often as they needed.
To correctly use it, fresh lime needed to be washed and cut into several small pieces by 1st cutting each lime into quarters and then each quarter further into 4 pieces.
When needed, subjects were told to suck each piece of lime and thereafter chew the lime skin.
To maintain freshness, the remaining slices were to be covered with plastic wrap and stored in the refrigerator as soon as possible.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
continuous abstinence rate (CAR) of lime group and gum group
Time Frame: week 12
|
CAR from week 9 through week 12 of treatment was defined as proportion of participants who self-reported having refrained from smoking any tobacco products and confirmed by exhaled CO concentration of 10 ppm or less at all previous measurement points between week 9 and week 12 of treatment.
|
week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with Adverse Events on each group
Time Frame: week 12
|
All adverse events related to the use of nicotine gum and fresh lime during the 12-week treatment were measured as number and percent of participants in each group.
|
week 12
|
7-day point prevalence abstinence (PAR) of lime and gum groups
Time Frame: week 4
|
Point prevalence abstinence rate (PAR), which was defined as percentage of participants who were able to abstain from smoking any tobacco products during the preceding week, was evaluated at week 4, 8, 12 and 24.
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week 4
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7-day point prevalence abstinence (PAR) of lime and gum groups
Time Frame: week 8
|
Point prevalence abstinence rate (PAR), which was defined as percentage of participants who were able to abstain from smoking any tobacco products during the preceding week, was evaluated at week 4, 8, 12 and 24.
|
week 8
|
7-day point prevalence abstinence (PAR) of lime and gum groups
Time Frame: week 12
|
Point prevalence abstinence rate (PAR), which was defined as percentage of participants who were able to abstain from smoking any tobacco products during the preceding week, was evaluated at week 4, 8, 12 and 24.
|
week 12
|
continuous abstinence rates of the lime and gum groups
Time Frame: week 24
|
CAR from week 9 through week 24 of the study was defined as proportion of participants who self-reported having refrained from smoking any tobacco products and confirmed by exhaled CO concentration of 10 ppm or less at all previous measurement points between week 9 and week 24.
|
week 24
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intensity of craving using 100-mm VAS score
Time Frame: week 2
|
Intensity of cravings after morning awakening among smokers in both groups were recorded on the day of clinic visits at week 2, 4, 8, 12, and 24 of the study using 100-mm visual analogue scale (VAS).
Mean scores of those in the lime and gum groups was calculated and compared.
|
week 2
|
intensity of craving using 100-mm VAS score
Time Frame: week 4
|
Intensity of cravings after morning awakening among smokers in both groups were recorded on the day of clinic visits at week 2, 4, 8, 12, and 24 of the study using 100-mm visual analogue scale (VAS).
Mean scores of those in the lime and gum groups was calculated and compared.
|
week 4
|
intensity of craving using 100-mm VAS score
Time Frame: week 8
|
Intensity of cravings after morning awakening among smokers in both groups were recorded on the day of clinic visits at week 2, 4, 8, 12, and 24 of the study using 100-mm visual analogue scale (VAS).
Mean scores of those in the lime and gum groups was calculated and compared.
|
week 8
|
intensity of craving using 100-mm VAS score
Time Frame: week 12
|
Intensity of cravings after morning awakening among smokers in both groups were recorded on the day of clinic visits at week 2, 4, 8, 12, and 24 of the study using 100-mm visual analogue scale (VAS).
Mean scores of those in the lime and gum groups was calculated and compared.
|
week 12
|
intensity of craving using 100-mm VAS score
Time Frame: week 24
|
Intensity of cravings after morning awakening among smokers in both groups were recorded on the day of clinic visits at week 2, 4, 8, 12, and 24 of the study using 100-mm visual analogue scale (VAS).
Mean scores of those in the lime and gum groups was calculated and compared.
|
week 24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Suthat Rungruanghiranya, MD, Faculty of Medicine, Srinakharinwirot University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Rungruanghiranya S, Ekpanyaskul C, Hattapornsawan Y, Tundulawessa Y. Effect of nicotine polyestex gum on smoking cessation and quality of life. J Med Assoc Thai. 2008 Nov;91(11):1656-62.
- Lykkesfeldt J, Prieme H, Loft S, Poulsen HE. Effect of smoking cessation on plasma ascorbic acid concentration. BMJ. 1996 Jul 13;313(7049):91. doi: 10.1136/bmj.313.7049.91. No abstract available.
- Levin ED, Behm F, Carnahan E, LeClair R, Shipley R, Rose JE. Clinical trials using ascorbic acid aerosol to aid smoking cessation. Drug Alcohol Depend. 1993 Oct;33(3):211-23. doi: 10.1016/0376-8716(93)90108-3.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
April 6, 2011
First Submitted That Met QC Criteria
April 8, 2011
First Posted (Estimate)
April 11, 2011
Study Record Updates
Last Update Posted (Estimate)
April 11, 2011
Last Update Submitted That Met QC Criteria
April 8, 2011
Last Verified
August 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 50-00-0980-02/2552
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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