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

The recruitment status of this study is unknown because the information has not been verified recently.
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
Endpoint Classification: Efficacy Study
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:

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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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)
Genders Eligible for Study:   Both
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):

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
Health Authority: Canada: Ethics Review Committee

Keywords provided by Queen's University:
Acupuncture
smoking cessation

ClinicalTrials.gov processed this record on September 27, 2016