Auriculotherapy for Smoking Cessation: Pilot

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-06-30

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.

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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.

Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Arm 1

Stimulation of auriculotherapy points on both ears with functioning Stim Flex 400A TENS unit once a week for 5 weeks.

Group Type ACTIVE_COMPARATOR

Auriculotherapy using TENS unit Stim Flex 400A

Intervention Type DEVICE

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

Arm 2

Stimulation of auriculotherapy points on both ears with disabled Stim Flex 400A TENS unit once a week for 5 weeks.

Group Type PLACEBO_COMPARATOR

Auriculotherapy using TENS unit Stim Flex 400A

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes