Effect of Self-administered Auricular Acupressure on Smoking Cessation—a Pilot Study

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

Auricular acupressure has been practiced in China and Germany to help people in smoking cessation programs. The purpose of this clinical trial is to test for the clinical effectiveness of self-administered auricular acupressure as a non-invasive method for smoking cessation.

Condition or disease	Intervention/treatment	Phase
Smoking Cessation	Other: acupuncture	Phase 2

Detailed Description:

Auricular acupressure has been practiced in China and Germany to help people in smoking cessation programs with varying degrees of success in different settings. The purpose of this clinical trial is to test for the clinical effectiveness of self-administered auricular acupressure as a non-invasive method for smoking cessation.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Supportive Care
Official Title:	Effect of Self-administered Auricular Acupressure on Smoking Cessation—a Pilot Study
Study Start Date :	July 2011
Estimated Primary Completion Date :	December 2015
Estimated Study Completion Date :	January 2016

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Arm 1: NADA points and digital pressure; Arm 1: NADA points and digital pressure with urge.	Other: acupuncture; National Acupuncture Detoxification Association (NADA) points + digital pressure
Experimental: Arm 2: random points + digital pressure with urge; Arm 2 (20 participants): random points + digital pressure with urge	Other: acupuncture; random points + digital pressure
No Intervention: Arm 3 (20 participants): NO acupressure, only advice + support

Outcome Measures

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Primary Outcome Measures :

1. Spot 7-day cessation rate [ Time Frame: Weekly during the intervention period (weeks 1-6) ]
   Efficacy of intervention for smoking cessation

Secondary Outcome Measures :

1. Continuous Cessation Rate (CAR) [ Time Frame: Weekly during the intervention period (weeks 1-6) and week 13 and week 26 ]
   Efficacy of intervention for smoking cessation
2. End-expiratory carbon monoxide levels (CO) [ Time Frame: Weekly during the intervention period (weeks 1-6) and week 13 and week 26 ]
   Efficacy of intervention for smoking cessation
3. Adverse effects in terms of self-reported discomfort levels from auricular acupressure [ Time Frame: Weekly during the intervention period (weeks 1-6) ]
   Nature and incidence of adverse events due to intervention
4. Stress level according to the Stress Check List (SCL) [ Time Frame: Weekly during the intervention period (weeks 1-6) and week 13 and week 26 ]
   Nature and incidence of adverse events due to intervention
5. Nicotine withdrawal symptoms according to Minnesota Nicotine Withdrawal Scale (MNWS) [ Time Frame: Weekly during the intervention period (weeks 1-6) and week 13 and week 26 ]
   Nature and incidence of adverse events due to intervention

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• Participants are included in the study if they satisfy the following criteria:

  • Male or female.
  • Between 18 and 75 years of age inclusive.
  • Able to provide informed consent to study.
  • History of tobacco cigarette smoking for at least 6 months.
  • Confirmed intention of smoking cessation with no more than 2 previous failed attempts in the last 3 year.

Exclusion Criteria:

• Existing pharmacotherapy for smoking cessation.
• History of major psychiatric disorder or chronic pain syndromes.
• More than 2 failed attempts of smoking cessation in the previous 3 years.
• History of other substance abuse.
• History of atopy, or suspected/known allergy to plaster.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Lawrence Leung, MD	613-533-9303	lawrence.leung@dfm.queensu.ca
Contact: Jyoti Kotecha, MPA	613-533-6000 ext 73970	jyoti.kotecha@cspc.queensu.ca

Locations

Canada, Ontario
Queen's Family Health Team	Recruiting
Kingston, Ontario, Canada, K7L 5E9
Contact: Lawrence Leung, MD 613-533-9300
Contact: Jyoti Kotecha, MPA 613-533-6000 ext 73970 jyoti.kotecha@dfm.queensu.ca

Sponsors and Collaborators

Queen's University

Investigators

Principal Investigator:	Lawrence Leung, MD	Queen's University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Leung L, Neufeld T, Marin S. Effect of self-administered auricular acupressure on smoking cessation--a pilot study. BMC Complement Altern Med. 2012 Feb 28;12:11. doi: 10.1186/1472-6882-12-11.

Responsible Party:	Queen's University
ClinicalTrials.gov Identifier:	NCT01389622 History of Changes
Other Study ID Numbers:	SMC01
First Posted:	July 8, 2011
Last Update Posted:	November 18, 2014
Last Verified:	March 2014

Keywords provided by Queen's University:

Acupuncture; smoking cessation