Auriculotherapy for Smoking Cessation: Pilot

Not Applicable

Completed

Brief 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. 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.

Recruitment & Eligibility

Inclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
Arm 1	Auriculotherapy using TENS unit Stim Flex 400A	Stimulation of auriculotherapy points on both ears with functioning Stim Flex 400A TENS unit once a week for 5 weeks.
Arm 2	Auriculotherapy using TENS unit Stim Flex 400A	Stimulation of auriculotherapy points on both ears with disabled Stim Flex 400A TENS unit once a week for 5 weeks.

Primary Outcome Measures