Auriculotherapy for Smoking Cessation: Pilot
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ClinicalTrials.gov Identifier: NCT01189110 |
Recruitment Status :
Completed
First Posted : August 26, 2010
Results First Posted : April 15, 2014
Last Update Posted : April 28, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Smoking Cessation | Device: Auriculotherapy using TENS unit Stim Flex 400A | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 125 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Auriculotherapy for Smoking Cessation |
Study Start Date : | August 2010 |
Actual Primary Completion Date : | March 2011 |
Actual Study Completion Date : | June 2011 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Arm 1
Stimulation of auriculotherapy points on both ears with functioning Stim Flex 400A TENS unit once a week for 5 weeks.
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Device: Auriculotherapy using TENS unit Stim Flex 400A
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 |
Placebo Comparator: Arm 2
Stimulation of auriculotherapy points on both ears with disabled Stim Flex 400A TENS unit once a week for 5 weeks.
|
Device: Auriculotherapy using TENS unit Stim Flex 400A
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 |
- 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).

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Do not meet any exclusion criteria; age 19 and above.
Exclusion Criteria:
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01189110
United States, Missouri | |
St. Louis VA Medical Center John Cochran Division, St. Louis, MO | |
St Louis, Missouri, United States, 63106 |
Principal Investigator: | Deborah Jean Fritz, PhD | St. Louis VA Medical Center John Cochran Division, St. Louis, MO |
Responsible Party: | US Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT01189110 |
Other Study ID Numbers: |
NRI 08-371 |
First Posted: | August 26, 2010 Key Record Dates |
Results First Posted: | April 15, 2014 |
Last Update Posted: | April 28, 2015 |
Last Verified: | August 2013 |
smoking cessation veterans auriculotherapy |