Clinical trial NCT01389622: Effect of Self-administered Auricular Acupressure on Smoking Cessation-a Pilot Study
Official title: Effect of Self-administered Auricular Acupressure on Smoking Cessation-a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Smoking Cessation
Keywords: Acupuncture
smoking cessation
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2011-07-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: Spot 7-day cessation rate
timeFrame: Weekly during the intervention period (weeks 1-6)
Secondary outcomes:
measure: Continuous Cessation Rate (CAR)
timeFrame: Weekly during the intervention period (weeks 1-6) and week 13 and week 26
measure: End-expiratory carbon monoxide levels (CO)
timeFrame: Weekly during the intervention period (weeks 1-6) and week 13 and week 26
measure: Adverse effects in terms of self-reported discomfort levels from auricular acupressure
timeFrame: Weekly during the intervention period (weeks 1-6)
measure: Stress level according to the Stress Check List (SCL)
timeFrame: Weekly during the intervention period (weeks 1-6) and week 13 and week 26
measure: Nicotine withdrawal symptoms according to Minnesota Nicotine Withdrawal Scale (MNWS)
timeFrame: Weekly during the intervention period (weeks 1-6) and week 13 and week 26
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Queen's Family Health Team
state: Ontario
Study officials:
affiliation: Queen's University
name: Lawrence Leung, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.