NCT02298127

Brief Summary

The purpose of this study is to evaluate the potential efficacy of auricular acupressure to stimulate specific acupoints in enhancing smoking cessation by reducing nicotine withdrawal symptoms among attendees in primary healthcare settings.

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
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2014

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 21, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

November 21, 2014

Status Verified

November 1, 2014

Enrollment Period

1.9 years

First QC Date

November 16, 2014

Last Update Submit

November 20, 2014

Conditions

Smoking Cessation

Keywords

smoking cessationauricular acupressureprimary care settingsrandomized controlled trial

Outcome Measures

Primary Outcomes (3)

  • 7-day point prevalence by self report

    1.25 month after the initial contact

  • 7-day point prevalence by self report, validated by biochemical measures

    Obtaining CO measurement and testing urinary cotinine for those participants who report quitting smoking

    6 month

  • Withdrawal symptoms

    Measured by two biomarkers for nicotine dependence: the gene expression level of nicotinic acetylcholine receptors (nAChRs) and dopamine level

    1.25 month after the initial contact

Secondary Outcomes (2)

  • Feasibility outcome assessed in terms of participant recruitment, acupressure session attendance, retention, preference for using TCM for smoking cessation, perceived usefulness and confidence of quitting smoking by acupressure

    6 month

  • Acceptability: Subjective data on acceptability of auricular acupressure for smoking cessation

    1 month

Study Arms (3)

Shenmen, mouth, lung & stomach

EXPERIMENTAL

Participants in this group will receive 4 weekly treatment sessions of auricular acupressure via the shenmen, mouth, lung and stomach.

Other: Auricular acupressure

Subcortex,endocrine&sympathetic systems

EXPERIMENTAL

Participants in this group will receive 4 weekly treatment sessions of auricular acupressure via the subcortex, endocrine and sympathetic systems.

Other: Auricular acupressure

Elbow, shoulder & knee

SHAM COMPARATOR

Participants in this group will receive 4 weekly treatment sessions of sham-controlled acupressure on the elbow, shoulder and knee acupoints on the auricle that is non-specific to smoking cessation.

Other: Auricular acupressure

Interventions

Auricular acupressureOTHER

For each auricular acupressure weekly session, magnetic ears tacks will be will be applied by certified traditional Chinese medicine practitioners according to the allocated group assignment, for a duration of one month.

Elbow, shoulder & kneeShenmen, mouth, lung & stomachSubcortex,endocrine&sympathetic systems

Eligibility Criteria

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

You may qualify if:

  • Aged 18 years and over
  • Currently smoking at least one cigarette per day in the past 30 days
  • Are Hong Kong residents
  • Able to communicate in Cantonese
  • Currently reside in Hong Kong and expect to continue to do so for the next 6 months
  • Have access to a telephone

You may not qualify if:

  • Currently undergoing other smoking cessation or similar programme
  • With a known history of allergy to adhesive tapes or history of current otitis externa or other ear disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Nursing, The Hong Kong Polytechnic University

Hung Hom, Kowloon, Hong Kong

RECRUITING

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • YW Mak, PhD

    School of Nursing, The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

YW Mak, PhD

CONTACT

852-2766-6421hsywmak@polyu.edu.hk

V Chiang

CONTACT

852-2766-6683vico.chiang@polyu.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 16, 2014

First Posted

November 21, 2014

Study Start

July 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

November 21, 2014

Record last verified: 2014-11

Locations

HK(1)