Fresh Lime Alone for Smoking Cessation (LIM)

This study has been completed.
Sponsor:
Information provided by:
Thai Health Professional Alliance Against Tobacco
ClinicalTrials.gov Identifier:
NCT01333202
First received: April 6, 2011
Last updated: April 8, 2011
Last verified: August 2010
  Purpose

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


Condition Intervention
Tobacco Use Disorder
Other: Fresh lime

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Fresh Lime Alone for Smoking Cessation

Resource links provided by NLM:


Further study details as provided by Thai Health Professional Alliance Against Tobacco:

Primary Outcome Measures:
  • continuous abstinence rate (CAR) of lime group and gum group [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: week 12 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    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 [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: week 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: week 2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    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 [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: week 24 ] [ Designated as safety issue: No ]
    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.


Enrollment: 100
Study Start Date: March 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Other Name: Fresh lime (Citrus aurantifolia)
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.
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.
Other Name: Fresh lime (Citrus aurantifolia)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01333202

Locations
Thailand
Panyananthaphikkhu Chonprathan Medical Center
Plakred, Nondhaburi, Thailand, 11120
Sponsors and Collaborators
Thai Health Professional Alliance Against Tobacco
Investigators
Principal Investigator: Suthat Rungruanghiranya, MD Faculty of Medicine, Srinakharinwirot University
  More Information

Publications:
Responsible Party: Dr.Suthat Rungruanghiranya, Faculty of Medicine, Srinakharinwirot University
ClinicalTrials.gov Identifier: NCT01333202     History of Changes
Other Study ID Numbers: 50-00-0980-02/2552
Study First Received: April 6, 2011
Last Updated: April 8, 2011
Health Authority: Thailand: Ethical Committee

Keywords provided by Thai Health Professional Alliance Against Tobacco:
Fresh lime
nicotine gum
smoking cessation
craving

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014