Tobacco Use DisorderLIMNCT01333202
Fresh Lime Alone for Smoking Cessation
A study testing Fresh lime in people with Tobacco Use Disorder, run by Thai Health Professional Alliance Against Tobacco at 1 site in Thailand.
Trial summary
The purpose of this study is to determine whether fresh lime alone is effective for smoking cessation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Fresh lime
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2009to Sep 2009
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age over 18
- Smoked regularly at least one year prior to study entry
- Had the desire to quit smoking
- Signed informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Panyananthaphikkhu Chonprathan Medical Center
Ban Plak Raet, Nondhaburi, 11120
About this study
Official title: 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.
Read the 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.
- Conditions
- Tobacco Use Disorder
- Being tested
- Fresh lime
- Keywords
- Fresh lime, nicotine gum, smoking cessation, craving
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresh limeOther
Also called Fresh lime (Citrus aurantifolia)
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.
| Study group | Role | What they receive |
|---|---|---|
| Fresh lime | Experimental | 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. Receives: Other: Fresh lime |
| Nicotine gum | Active comparator | 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. Receives: Other: Fresh lime |
What is being measured
The primary outcome is the main question the study is designed to answer.
continuous abstinence rate (CAR) of lime group and gum group
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.
Measured: week 12
Secondary outcomes (10)
Number of Participants with Adverse Events on each group
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.
Measured: week 12
7-day point prevalence abstinence (PAR) of lime and gum groups
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.
Measured: week 4
7-day point prevalence abstinence (PAR) of lime and gum groups
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.
Measured: week 8
7-day point prevalence abstinence (PAR) of lime and gum groups
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.
Measured: week 12
continuous abstinence rates of the lime and gum groups
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.
Measured: week 24
intensity of craving using 100-mm VAS score
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.
Measured: week 2
intensity of craving using 100-mm VAS score
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.
Measured: week 4
intensity of craving using 100-mm VAS score
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.
Measured: week 8
intensity of craving using 100-mm VAS score
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.
Measured: week 12
intensity of craving using 100-mm VAS score
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.
Measured: week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2011 (estimated)
- Study startMar 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thai Health Professional Alliance Against Tobacco
- Sponsor type
- University, hospital or other
- Investigators
- Suthat Rungruanghiranya, MD, Principal investigator, Faculty of Medicine, Srinakharinwirot University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01333202
- Sponsor's protocol ID
- 50-00-0980-02/2552
- Acronym
- LIM
- Status last verified
- Aug 2010
- First submitted
- 6 Apr 2011
- Last updated
- 11 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 19127785Lykkesfeldt 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.
PubMed 8688760Levin 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.
PubMed 8261886
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Fresh Lime Alone for Smoking Cessation
- ClinicalTrials.gov ID
- NCT01333202
- Acronym / sponsor ID
- LIM / 50-00-0980-02/2552
- Conditions
- Tobacco Use Disorder
- Keywords
- Fresh lime, nicotine gum, smoking cessation, craving
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Thai Health Professional Alliance Against TobaccoUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 11 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether fresh lime alone is effective for smoking cessation.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fresh lime | Experimental | Other: Fresh limeThose 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. |
| Nicotine gum | Active comparator | Other: Fresh limeThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 18
- Smoked regularly at least one year prior to study entry
- Had the desire to quit smoking
- Signed informed consent
Key exclusion criteria (7 listed)
- Having current dental problems
- Active peptic ulcer disease
- Psychiatric disorders
- Citrus allergy
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fresh limeAlso: Fresh lime (Citrus aurantifolia)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 | Fresh lime, Nicotine gum |
Primary outcome
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.
10 secondary outcomes
Number of Participants with Adverse Events on each group
Time frame: week 12
7-day point prevalence abstinence (PAR) of lime and gum groups
Time frame: week 4
7-day point prevalence abstinence (PAR) of lime and gum groups
Time frame: week 8
7-day point prevalence abstinence (PAR) of lime and gum groups
Time frame: week 12
continuous abstinence rates of the lime and gum groups
Time frame: week 24
intensity of craving using 100-mm VAS score
Time frame: week 2
intensity of craving using 100-mm VAS score
Time frame: week 4
intensity of craving using 100-mm VAS score
Time frame: week 8
intensity of craving using 100-mm VAS score
Time frame: week 12
intensity of craving using 100-mm VAS score
Time frame: week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2011.
- Results publication: PubMed 19127785Rungruanghiranya 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.
- Results publication: PubMed 8688760Lykkesfeldt 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.
- Results publication: PubMed 8261886Levin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suthat Rungruanghiranya, MD principal investigator
Faculty of Medicine, Srinakharinwirot University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fresh lime in people with Tobacco Use Disorder, run by Thai Health Professional Alliance Against Tobacco at 1 site in Thailand.
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 4 inclusion and 7 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 11 Apr 2011. 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 Thailand. 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?
continuous abstinence rate (CAR) of lime group and gum group (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01333202, which also lists 3 linked publications.
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 11 Apr 2011.