Auriculotherapy for Smoking Cessation: Pilot

Study Overview
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Brief Summary
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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
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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.

Official Title
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Auriculotherapy for Smoking Cessation

Conditions
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Smoking Cessation

Intervention / Treatment
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* Device: Auriculotherapy using TENS unit Stim Flex 400A


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br>Stimulation of auriculotherapy points on both ears with functioning Stim Flex 400A TENS unit once a week for 5 weeks. | Device: Auriculotherapy using TENS unit Stim Flex 400A<br>* 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<br>|
| Placebo Comparator: Arm 2<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Self-reported Abstinence at 6 Weeks. | Percentage of study participants free from smoking at 6 weeks based on self-report (yes/no). | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking cessation, veterans, auriculotherapy