Smoking CessationPhase 2NCT01389622
Effect of Self-administered Auricular Acupressure on Smoking Cessation-a Pilot Study
A Phase 2 study testing acupuncture in people with Smoking Cessation, run by Queen's University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2011to Jan 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Queen's Family Health Team
Kingston, Ontario, K7L 5E9
Lawrence Leung, MD, 613-533-9300
Jyoti Kotecha, MPA, 613-533-6000 ext. 73970, jyoti.kotecha@dfm.queensu.ca
About this 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.
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- acupuncture
- Keywords
- Acupuncture, smoking cessation
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureOther
National Acupuncture Detoxification Association (NADA) points + digital pressure
acupunctureOther
random points + digital pressure
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: NADA points and digital pressure | Experimental | Arm 1: NADA points and digital pressure with urge. Receives: Other: acupuncture |
| Arm 2: random points + digital pressure with urge | Experimental | Arm 2 (20 participants): random points + digital pressure with urge Receives: Other: acupuncture |
| Arm 3 (20 participants): NO acupressure, only advice + support | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spot 7-day cessation rate
Efficacy of intervention for smoking cessation
Measured: Weekly during the intervention period (weeks 1-6)
Secondary outcomes (5)
Continuous Cessation Rate (CAR)
Efficacy of intervention for smoking cessation
Measured: Weekly during the intervention period (weeks 1-6) and week 13 and week 26
End-expiratory carbon monoxide levels (CO)
Efficacy of intervention for smoking cessation
Measured: 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
Nature and incidence of adverse events due to intervention
Measured: Weekly during the intervention period (weeks 1-6)
Stress level according to the Stress Check List (SCL)
Nature and incidence of adverse events due to intervention
Measured: Weekly during the intervention period (weeks 1-6) and week 13 and week 26
Nicotine withdrawal symptoms according to Minnesota Nicotine Withdrawal Scale (MNWS)
Nature and incidence of adverse events due to intervention
Measured: Weekly during the intervention period (weeks 1-6) and week 13 and week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2015 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lawrence Leung, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389622
- Sponsor's protocol ID
- SMC01
- Status last verified
- Mar 2014
- First submitted
- 29 Jun 2011
- Last updated
- 18 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22373002
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Self-administered Auricular Acupressure on Smoking Cessation-a Pilot Study
- ClinicalTrials.gov ID
- NCT01389622
- Acronym / sponsor ID
- SMC01
- Conditions
- Smoking Cessation
- Keywords
- Acupuncture, smoking cessation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 8 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: NADA points and digital pressure | Experimental | Other: acupunctureArm 1: NADA points and digital pressure with urge. |
| Arm 2: random points + digital pressure with urge | Experimental | Other: acupunctureArm 2 (20 participants): random points + digital pressure with urge |
| Arm 3 (20 participants): NO acupressure, only advice + support | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants are included in the study if they satisfy the following criteria:
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupunctureNational Acupuncture Detoxification Association (NADA) points + digital pressure | Other | Arm 1: NADA points and digital pressure |
| acupuncturerandom points + digital pressure | Other | Arm 2: random points + digital pressure with urge |
Primary outcome
Spot 7-day cessation rate
Time frame: Weekly during the intervention period (weeks 1-6)
Efficacy of intervention for smoking cessation
5 secondary outcomes
Continuous Cessation Rate (CAR)
Time frame: Weekly during the intervention period (weeks 1-6) and week 13 and week 26
End-expiratory carbon monoxide levels (CO)
Time frame: 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
Time frame: Weekly during the intervention period (weeks 1-6)
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2014.
- Derived from this study: PubMed 22373002Leung 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.
Related trials for Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence Leung, MD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing acupuncture in people with Smoking Cessation, run by Queen's University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lawrence Leung, MD (613-533-9303, lawrence.leung@dfm.queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spot 7-day cessation rate (time frame: Weekly during the intervention period (weeks 1-6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01389622, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2014.