Clinical trial NCT01189110: Auriculotherapy for Smoking Cessation: Pilot
Official title: Auriculotherapy for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: smoking cessation
veterans
auriculotherapy
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2010-08-26
Enrollment: 125
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Self-reported Abstinence at 6 Weeks.
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: St Louis
country: United States
facility: St. Louis VA Medical Center John Cochran Division, St. Louis, MO
state: Missouri
Study officials:
affiliation: St. Louis VA Medical Center John Cochran Division, St. Louis, MO
name: Deborah Jean Fritz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.