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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified March 2014 by Queen's University.
Recruitment status was: Recruiting

Sponsor:

Information provided by (Responsible Party):

Queen's University

ClinicalTrials.gov Identifier:

NCT01389622

First received: June 29, 2011

Last updated: November 17, 2014

Last verified: March 2014

History of Changes

Purpose

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	Intervention	Phase
Smoking Cessation	Other: acupuncture	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	Effect of Self-administered Auricular Acupressure on Smoking Cessation—a Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Quitting Smoking Smoking

U.S. FDA Resources

Further study details as provided by Queen's University:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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
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
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
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
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


Estimated Enrollment:	60
Study Start Date:	July 2011
Estimated Study Completion Date:	January 2016
Estimated Primary Completion Date:	December 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


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

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: NCT01389622

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

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
Study First Received:	June 29, 2011
Last Updated:	November 17, 2014

Keywords provided by Queen's University:


Acupuncture smoking cessation

ClinicalTrials.gov processed this record on June 23, 2017

To Top