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Fresh Lime Alone for Smoking Cessation (LIM)

Primary Purpose

Tobacco Use Disorder

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Fresh lime
Sponsored by
Thai Health Professional Alliance Against Tobacco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Use Disorder focused on measuring Fresh lime, nicotine gum, smoking cessation, craving

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Panyananthaphikkhu Chonprathan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fresh lime

Nicotine gum

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
April 6, 2011
Last Updated
April 8, 2011
Sponsor
Thai Health Professional Alliance Against Tobacco
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1. Study Identification

Unique Protocol Identification Number
NCT01333202
Brief Title
Fresh Lime Alone for Smoking Cessation
Acronym
LIM
Official Title
Efficacy of Fresh Lime Alone for Smoking Cessation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Thai Health Professional Alliance Against Tobacco

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
Keywords
Fresh lime, nicotine gum, smoking cessation, craving

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fresh lime
Arm Type
Experimental
Arm Description
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.
Arm Title
Nicotine gum
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Fresh lime
Other Intervention Name(s)
Fresh lime (Citrus aurantifolia)
Intervention Description
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.
Primary Outcome Measure Information:
Title
continuous abstinence rate (CAR) of lime group and gum group
Description
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.
Time Frame
week 12
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events on each group
Description
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.
Time Frame
week 12
Title
7-day point prevalence abstinence (PAR) of lime and gum groups
Description
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.
Time Frame
week 4
Title
7-day point prevalence abstinence (PAR) of lime and gum groups
Description
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.
Time Frame
week 8
Title
7-day point prevalence abstinence (PAR) of lime and gum groups
Description
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.
Time Frame
week 12
Title
continuous abstinence rates of the lime and gum groups
Description
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.
Time Frame
week 24
Title
intensity of craving using 100-mm VAS score
Description
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.
Time Frame
week 2
Title
intensity of craving using 100-mm VAS score
Description
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.
Time Frame
week 4
Title
intensity of craving using 100-mm VAS score
Description
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.
Time Frame
week 8
Title
intensity of craving using 100-mm VAS score
Description
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.
Time Frame
week 12
Title
intensity of craving using 100-mm VAS score
Description
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.
Time Frame
week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suthat Rungruanghiranya, MD
Organizational Affiliation
Faculty of Medicine, Srinakharinwirot University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Panyananthaphikkhu Chonprathan Medical Center
City
Plakred
State/Province
Nondhaburi
ZIP/Postal Code
11120
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
19127785
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.
Results Reference
result
PubMed Identifier
8688760
Citation
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.
Results Reference
result
PubMed Identifier
8261886
Citation
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.
Results Reference
result

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Fresh Lime Alone for Smoking Cessation

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