Fresh Lime Alone for Smoking Cessation

NCT01333202 | Completed

• 1 other identifier: 50-00-0980-02/2552
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tobacco Use Disorder

Keywords

Fresh lime; nicotine gum; smoking cessation; craving

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Number of Participants with Adverse Events on each group

  week 12

• 7-day point prevalence abstinence (PAR) of lime and gum groups

  week 4

• 7-day point prevalence abstinence (PAR) of lime and gum groups

  week 8

• 7-day point prevalence abstinence (PAR) of lime and gum groups

  week 12

• continuous abstinence rates of the lime and gum groups

  week 24

Study Arms (2)

Fresh lime

EXPERIMENTAL

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

Nicotine gum

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Fresh lime (Citrus aurantifolia)

Fresh lime; Nicotine gum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18
• Smoked regularly at least one year prior to study entry
• Had the desire to quit smoking
• Signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Thai Health Professional Alliance Against Tobacco: lead

Study Sites (1)

Panyananthaphikkhu Chonprathan Medical Center

Ban Plak Raet, Nondhaburi, 11120, Thailand

Location

Related Publications (3)

• 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.

  PMID: 19127785 RESULT

• 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.

  PMID: 8688760 RESULT

• 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.

  PMID: 8261886 RESULT

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking Cessation

Interventions

lime

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Study Officials

• Suthat Rungruanghiranya, MD

  Faculty of Medicine, Srinakharinwirot University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 6, 2011
• First Posted: April 11, 2011
• Study Start: March 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: April 11, 2011

Record last verified: 2010-08

Locations

TH (1)