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Completed

NCT Number: NCT01333202

Fresh Lime Alone for Smoking Cessation

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

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Key information

Conditions

Tobacco Use Disorder Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Smoking Cessation Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Panyananthaphikkhu Chonprathan Medical Center

Ban Plak Raet, Nondhaburi, 11120, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fresh lime

Other

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: Fresh lime (Citrus aurantifolia)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

Thai Health Professional Alliance Against Tobacco

Other

Registry information

Official study title

Efficacy of Fresh Lime Alone for Smoking Cessation

Acronym: LIM

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 11, 2011
Registry last updated
Apr 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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