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

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01389622
• Other study ID #: SMC01
• Status: Recruiting
• Phase: Phase 2
• First received: June 29, 2011
• Last updated: November 17, 2014
• Start date: July 2011
• Est. completion date: January 2016

Study information

• Verified date: March 2014
• Source: Queen's University
• Contact: Lawrence Leung, MD
• Phone: 613-533-9303
• Email: lawrence.leung[@]dfm.queensu.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Other:
• acupuncture
National Acupuncture Detoxification Association (NADA) points + digital pressure
• acupuncture
random points + digital pressure

Locations

Country	Name	City	State
Canada	Queen's Family Health Team	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spot 7-day cessation rate	Efficacy of intervention for smoking cessation	Weekly during the intervention period (weeks 1-6)	No
Secondary	Continuous Cessation Rate (CAR)	Efficacy of intervention for smoking cessation	Weekly during the intervention period (weeks 1-6) and week 13 and week 26	No
Secondary	End-expiratory carbon monoxide levels (CO)	Efficacy of intervention for smoking cessation	Weekly during the intervention period (weeks 1-6) and week 13 and week 26	No
Secondary	Adverse effects in terms of self-reported discomfort levels from auricular acupressure	Nature and incidence of adverse events due to intervention	Weekly during the intervention period (weeks 1-6)	Yes
Secondary	Stress level according to the Stress Check List (SCL)	Nature and incidence of adverse events due to intervention	Weekly during the intervention period (weeks 1-6) and week 13 and week 26	Yes
Secondary	Nicotine withdrawal symptoms according to Minnesota Nicotine Withdrawal Scale (MNWS)	Nature and incidence of adverse events due to intervention	Weekly during the intervention period (weeks 1-6) and week 13 and week 26	Yes