NCT01389622

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2011

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2011

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 8, 2011

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

November 18, 2014

Status Verified

March 1, 2014

Enrollment Period

4.4 years

First QC Date

June 29, 2011

Last Update Submit

November 17, 2014

Conditions

Smoking Cessation

Keywords

Acupuncturesmoking cessation

Outcome Measures

Primary Outcomes (1)

  • Spot 7-day cessation rate

    Efficacy of intervention for smoking cessation

    Weekly during the intervention period (weeks 1-6)

Secondary Outcomes (5)

  • Continuous Cessation Rate (CAR)

    Weekly during the intervention period (weeks 1-6) and week 13 and week 26

  • End-expiratory carbon monoxide levels (CO)

    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

    Weekly during the intervention period (weeks 1-6)

  • Stress level according to the Stress Check List (SCL)

    Weekly during the intervention period (weeks 1-6) and week 13 and week 26

  • Nicotine withdrawal symptoms according to Minnesota Nicotine Withdrawal Scale (MNWS)

    Weekly during the intervention period (weeks 1-6) and week 13 and week 26

Study Arms (3)

Arm 1: NADA points and digital pressure

EXPERIMENTAL

Arm 1: NADA points and digital pressure with urge.

Other: acupuncture

Arm 2: random points + digital pressure with urge

EXPERIMENTAL

Arm 2 (20 participants): random points + digital pressure with urge

Other: acupuncture

Arm 3 (20 participants): NO acupressure, only advice + support

NO INTERVENTION

Interventions

acupunctureOTHER

National Acupuncture Detoxification Association (NADA) points + digital pressure

Arm 1: NADA points and digital pressure

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen's Family Health Team

Kingston, Ontario, K7L 5E9, Canada

RECRUITING

Related Publications (1)

  • 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.

    PMID: 22373002DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Lawrence Leung, MD

    Queen's University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lawrence Leung, MD

CONTACT

613-533-9303lawrence.leung@dfm.queensu.ca

Jyoti Kotecha, MPA

CONTACT

613-533-6000jyoti.kotecha@cspc.queensu.ca

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2011

First Posted

July 8, 2011

Study Start

July 1, 2011

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

November 18, 2014

Record last verified: 2014-03

Locations

CA(1)