Smoking CessationNCT01189110
Auriculotherapy for Smoking Cessation: Pilot
A study testing Auriculotherapy using TENS unit Stim Flex 400A in people with Smoking Cessation, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Thirty three percent of our veterans currently smoke. Encouraging smoking cessation continues to be a top priority for the Veteran's Administration as smoking is the single most important preventable risk factor for mortality and morbidity. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Auriculotherapy using TENS unit Stim Flex 400A
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Jun 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Do not meet any exclusion criteria; age 19 and above.
Who cannot join
- Veterans will be excluded from the study if they:
- have history or current evidence of pathological condition of the ear (e.g. infection, inflammation, or skin disruption of the auricle
- are known to be pregnant (positive urine pregnancy test)
- have an indwelling cardiac pacemaker or defibrillator
- are actively psychotic (as evidenced by delusions, hallucinations, or disorganization), have a severe cognitive impairment, or current significant substance abuse disorder that might prevent full participation in this study. Also excluded are those who score greater than 20 on the PHQ-9 screening tool for depression
- refuse to sign an informed consent form
- have been on bupropion and/or nicotine patch in the past one month or intend to start bupropion and/or nicotine patch in the next 6 weeks.
- Have a urine cotinine level less than 3.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Louis VA Medical Center John Cochran Division, St. Louis, MO
St Louis, Missouri, 63106
About this study
Official title: Auriculotherapy for Smoking Cessation
Thirty three percent of our veterans currently smoke. Encouraging smoking cessation continues to be a top priority for the Veteran's Administration as smoking is the single most important preventable risk factor for mortality and morbidity. This study attempts to determine whether auriculotherapy may be used as an effective alternative to usual pharmacological interventions currently offered. Identifying an efficacious alternative method to nicotine patch or bupropion would be highly beneficial to veterans who want to quit smoking. This clinical trial took place at the Veterans Administration Medical Center, in conjunction with the smoking cessation clinic. One hundred twenty five veterans, male and female, age 19 or older, who smoked a minimum of 10 cigarettes per day, were evaluated for enrollment and randomized to two groups- true auriculotherapy and sham auriculotherapy in this 6 week trial.
Read the detailed description
Methods: This randomized, double-blind, placebo-controlled clinical trial of 125 veterans was conducted to determine whether aural electrical stimulation (auriculotherapy) with the Stim Flex 400A TENS unit once a week for 5 consecutive weeks is associated with a higher rate of smoking abstinence are than observed with sham stimulation.
- Conditions
- Smoking Cessation
- Being tested
- Auriculotherapy using TENS unit Stim Flex 400A
- Keywords
- smoking cessation, veterans, auriculotherapy
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auriculotherapy using TENS unit Stim Flex 400ADevice
Although the mechanism of action of auriculotherapy is not well understood, the dominant scientific theory for how traditional acupuncture procedures works has suggested possible neurophysiologic and neurochemical pathways that may explain its effectiveness for treating specific disorders
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Stimulation of auriculotherapy points on both ears with functioning Stim Flex 400A TENS unit once a week for 5 weeks. Receives: Device: Auriculotherapy using TENS unit Stim Flex 400A |
| Arm 2 | Placebo comparator | Stimulation of auriculotherapy points on both ears with disabled Stim Flex 400A TENS unit once a week for 5 weeks. Receives: Device: Auriculotherapy using TENS unit Stim Flex 400A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Self-reported Abstinence at 6 Weeks.
Percentage of study participants free from smoking at 6 weeks based on self-report (yes/no).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionMar 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Deborah Jean Fritz, PhD, Principal investigator, St. Louis VA Medical Center John Cochran Division, St. Louis, MO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01189110
- Sponsor's protocol ID
- NRI 08-371
- Status last verified
- Aug 2013
- First submitted
- 24 Aug 2010
- Last updated
- 28 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Fritz DJ, Carney RM, Steinmeyer B, Ditson G, Hill N, Zee-Cheng J. The efficacy of auriculotherapy for smoking cessation: a randomized, placebo-controlled trial. J Am Board Fam Med. 2013 Jan-Feb;26(1):61-70. doi: 10.3122/jabfm.2013.01.120157.
PubMed 23288282
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auriculotherapy for Smoking Cessation
- ClinicalTrials.gov ID
- NCT01189110
- Acronym / sponsor ID
- NRI 08-371
- Conditions
- Smoking Cessation
- Keywords
- smoking cessation, veterans, auriculotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Aug 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 26 Aug 2010 (estimated)
- Results
- Posted 15 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Thirty three percent of our veterans currently smoke. Encouraging smoking cessation continues to be a top priority for the Veteran's Administration as smoking is the single most important preventable risk factor for mortality and morbidity. This study attempts to determine whether auriculotherapy may be used as an effective alternative to usual pharmacological interventions currently offered. Identifying an efficacious alternative method to nicotine patch or bupropion would be highly beneficial to veterans who want to quit smoking. This clinical trial took place at the Veterans Administration Medical Center, in conjunction with the smoking cessation clinic. One hundred twenty five veterans, male and female, age 19 or older, who smoked a minimum of 10 cigarettes per day, were evaluated for enrollment and randomized to two groups- true auriculotherapy and sham auriculotherapy in this 6 week trial.
Detailed description
Methods: This randomized, double-blind, placebo-controlled clinical trial of 125 veterans was conducted to determine whether aural electrical stimulation (auriculotherapy) with the Stim Flex 400A TENS unit once a week for 5 consecutive weeks is associated with a higher rate of smoking abstinence are than observed with sham stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Device: Auriculotherapy using TENS unit Stim Flex 400AStimulation of auriculotherapy points on both ears with functioning Stim Flex 400A TENS unit once a week for 5 weeks. |
| Arm 2 | Placebo comparator | Device: Auriculotherapy using TENS unit Stim Flex 400AStimulation of auriculotherapy points on both ears with disabled Stim Flex 400A TENS unit once a week for 5 weeks. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Do not meet any exclusion criteria; age 19 and above.
Key exclusion criteria (8 listed)
- have history or current evidence of pathological condition of the ear (e.g. infection, inflammation, or skin disruption of the auricle
- are known to be pregnant (positive urine pregnancy test)
- have an indwelling cardiac pacemaker or defibrillator
- are actively psychotic (as evidenced by delusions, hallucinations, or disorganization), have a severe cognitive impairment, or current significant substance abuse disorder that might prevent full participation in this study. Also excluded are those who score greater than 20 on the PHQ-9 screening tool for depression
- refuse to sign an informed consent form
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 |
|---|---|---|
| Auriculotherapy using TENS unit Stim Flex 400AAlthough the mechanism of action of auriculotherapy is not well understood, the dominant scientific theory for how traditional acupuncture procedures works has suggested possible neurophysiologic and neurochemical pathways that may explain its effectiveness for treating specific disorders | Device | Arm 1, Arm 2 |
Primary outcome
Percentage of Self-reported Abstinence at 6 Weeks.
Time frame: 6 weeks
Percentage of study participants free from smoking at 6 weeks based on self-report (yes/no).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23288282Fritz DJ, Carney RM, Steinmeyer B, Ditson G, Hill N, Zee-Cheng J. The efficacy of auriculotherapy for smoking cessation: a randomized, placebo-controlled trial. J Am Board Fam Med. 2013 Jan-Feb;26(1):61-70. doi: 10.3122/jabfm.2013.01.120157.
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Comparing the Efficacy of a Conversational Agent (QuitBot) Versus Standard Health Education on Smoking Cessation Among Medical Students; A Randomized Controlled Trial.
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Using Smartwatches to Monitor Smoking in Real-life Situations
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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.
Deborah Jean Fritz, PhD principal investigator
St. Louis VA Medical Center John Cochran Division, St. Louis, MO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auriculotherapy using TENS unit Stim Flex 400A in people with Smoking Cessation, run by US Department of Veterans Affairs at 1 site in United States.
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 1 inclusion and 8 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: finished, as of the sponsor's last update on 28 Apr 2015. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Self-reported Abstinence at 6 Weeks. (time frame: 6 weeks). 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 NCT01189110, 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 28 Apr 2015.