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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Queen's University
Sponsor:
Information provided by (Responsible Party):
Queen's University
ClinicalTrials.gov Identifier:
NCT01389622
First received: June 29, 2011
Last updated: March 7, 2014
Last verified: March 2014

June 29, 2011
March 7, 2014
July 2011
December 2015   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01389622 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Effect of Self-administered Auricular Acupressure on Smoking Cessation—a Pilot Study
Effect of Self-administered Auricular Acupressure on Smoking Cessation—a Pilot Study

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Smoking Cessation
  • Other: acupuncture
    National Acupuncture Detoxification Association (NADA) points + digital pressure
  • Other: acupuncture
    random points + digital pressure
  • Experimental: Arm 1: NADA points and digital pressure
    Experimental arm with NADA points and digital pressure with urge.
    Intervention: Other: acupuncture
  • Experimental: Arm 2: random points + digital pressure with urge
    Arm 2 (20 participants): random points + digital pressure with urge
    Intervention: Other: acupuncture
  • No Intervention: Arm 3 (20 participants): NO acupressure, only advice + support
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
January 2016
December 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
Yes
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
Canada
 
NCT01389622
SMC01
No
Queen's University
Queen's University
Not Provided
Principal Investigator: Lawrence Leung, MD Queen's University
Queen's University
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP