Fresh Lime Alone for Smoking Cessation

Tobacco Use Disorder Clinical Trial

— LIM  

Official title:

Efficacy of Fresh Lime Alone for Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01333202
• Other study ID #: 50-00-0980-02/2552
• Status: Completed
• Phase: N/A
• First received: April 6, 2011
• Last updated: April 8, 2011
• Start date: March 2009
• Est. completion date: September 2009

Study information

• Verified date: August 2010
• Source: Thai Health Professional Alliance Against Tobacco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether fresh lime alone is effective for smoking cessation.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Other:
• Fresh lime
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.

Locations

Country	Name	City	State
Thailand	Panyananthaphikkhu Chonprathan Medical Center	Plakred	Nondhaburi

Sponsors (1)

Lead Sponsor	Collaborator
Thai Health Professional Alliance Against Tobacco

Country where clinical trial is conducted

Thailand, 

References & Publications (3)

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. — View Citation

Lykkesfeldt J, Priemé H, Loft S, Poulsen HE. Effect of smoking cessation on plasma ascorbic acid concentration. BMJ. 1996 Jul 13;313(7049):91. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	week 12
Secondary	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.	week 12
Secondary	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.	week 4
Secondary	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.	week 8
Secondary	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.	week 12
Secondary	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.	week 24
Secondary	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.	week 2
Secondary	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.	week 4
Secondary	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.	week 8
Secondary	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.	week 12
Secondary	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.	week 24