Clinical trial NCT01333202: Fresh Lime Alone for Smoking Cessation
Official title: Efficacy of Fresh Lime Alone for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Disorder
Keywords: Fresh lime
nicotine gum
smoking cessation
craving
Lead sponsor: Thai Health Professional Alliance Against Tobacco
Sponsor class: OTHER
First posted: 2011-04-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: continuous abstinence rate (CAR) of lime group and gum group
timeFrame: week 12
Secondary outcomes:
measure: Number of Participants with Adverse Events on each group
timeFrame: week 12
measure: 7-day point prevalence abstinence (PAR) of lime and gum groups
timeFrame: week 4
measure: 7-day point prevalence abstinence (PAR) of lime and gum groups
timeFrame: week 8
measure: 7-day point prevalence abstinence (PAR) of lime and gum groups
timeFrame: week 12
measure: continuous abstinence rates of the lime and gum groups
timeFrame: week 24
measure: intensity of craving using 100-mm VAS score
timeFrame: week 2
measure: intensity of craving using 100-mm VAS score
timeFrame: week 4
measure: intensity of craving using 100-mm VAS score
timeFrame: week 8
measure: intensity of craving using 100-mm VAS score
timeFrame: week 12
measure: intensity of craving using 100-mm VAS score
timeFrame: week 24
Other outcomes:
Locations:
city: Plakred
country: Thailand
facility: Panyananthaphikkhu Chonprathan Medical Center
state: Nondhaburi
Study officials:
affiliation: Faculty of Medicine, Srinakharinwirot University
name: Suthat Rungruanghiranya, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.