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

November 17, 2014 updated by: Queen's University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 5E9
        • Recruiting
        • Queen's Family Health Team
        • Contact:
          • Lawrence Leung, MD
          • Phone Number: 613-533-9300
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Weekly during the intervention period (weeks 1-6) and week 13 and week 26
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
Weekly during the intervention period (weeks 1-6) and week 13 and week 26
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
Weekly during the intervention period (weeks 1-6)
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
Weekly during the intervention period (weeks 1-6) and week 13 and week 26
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
Weekly during the intervention period (weeks 1-6) and week 13 and week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen's University

Investigators

  • Principal Investigator: Lawrence Leung, MD, Queen's University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

June 29, 2011

First Submitted That Met QC Criteria

July 6, 2011

First Posted (Estimate)

July 8, 2011

Study Record Updates

Last Update Posted (Estimate)

November 18, 2014

Last Update Submitted That Met QC Criteria

November 17, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SMC01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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