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

Phase 2

• Conditions: Smoking Cessation
• Interventions: Other: acupuncture

• Registration Number: NCT01389622
• Lead Sponsor: Queen's University

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.

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 Timeline

• Study First Submitted: 2011-06-29
• Study Start: 2011-07
• Study First Submitted QC: 2011-07-06
• Study First Posted: 2011-07-08
• Status Verified: 2014-03
• Last Update Submitted: 2014-11-17
• Last Update Posted: 2014-11-18
• Primary Completion: 2015-12
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: NADA points and digital pressure	acupuncture	Arm 1: NADA points and digital pressure with urge.
Arm 2: random points + digital pressure with urge	acupuncture	Arm 2 (20 participants): random points + digital pressure with urge

Primary Outcome Measures

Name	Time	Method
Spot 7-day cessation rate	Weekly during the intervention period (weeks 1-6)	Efficacy of intervention for smoking cessation

Secondary Outcome Measures

Name	Time	Method
End-expiratory carbon monoxide levels (CO)	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	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)	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)	Weekly during the intervention period (weeks 1-6) and week 13 and week 26	Nature and incidence of adverse events due to intervention
Continuous Cessation Rate (CAR)	Weekly during the intervention period (weeks 1-6) and week 13 and week 26	Efficacy of intervention for smoking cessation

Trial Locations

Locations (1)

Queen's Family Health Team; 🇨🇦 Kingston, Ontario, Canada