Auriculotherapy for Smoking Cessation
Verified by Department of Veterans Affairs, August 2010
First Received: August 24, 2010   Last Updated: August 27, 2010

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 pilot study will attempt 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 pilot study will take place at the VAMC, in conjunction with the smoking cessation clinic. One hundred twenty five veterans, male and female, age 19 or older, who smoke a minimum of 10 cigarettes per day, will be evaluated for enrollment with 50 participants in each group- true auriculotherapy and sham auriculotherapy completing at least 6 weeks of the trial.


Condition Intervention
Auriculotherapy
 Device: Auriculotherapy using TENS unit Stim Flex 400A

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Auriculotherapy for Smoking Cessation
Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • smoking abstinence [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 125
Study Start Date: August 2010
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Two separate Stim Flex machines will be used in this study: Machine A (usual care) will be a usual functioning machine which is FDA approved; Machine B (sham treatment) will be altered to disable the electrical current to flow to the probe. Otherwise both machines will be identical and function identical except at the time the electrical current is given thru the probe. There is no alteration to the outside of either Stem Flex machines, the alteration to the sham machine will be internal, and will appear and sound identical to the Stim Flex machine which has not been altered.
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
2: Placebo Comparator
Machine B (sham treatment) will be altered to disable the electrical current to flow to the probe. Otherwise both machines will be identical and function identical except at the time the electrical current is given thru the probe. There is no alteration to the outside of either Stem Flex machines, the alteration to the sham machine will be internal, and will appear and sound identical to the Stim Flex machine which has not been altered.
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

Detailed Description:

United States military veterans continue to smoke at a rate higher than the general population. Some veterans may not respond well to current standard treatments such as bupropion or nicotine replacement, or they may have contraindications to one or both of these drugs. In addition, veterans tend to have more co-morbid medical conditions and require higher levels of polypharmacy than many groups. Adding more drugs to an already complicated treatment regimen increases the risk for drug-drug interactions, and may compromise adherence to other medications.

This pilot study is proposed in preparation for a large, double blind, randomized, placebo controlled trial of a novel treatment for smoking cessation, auriculotherapy, compared to a sham intervention (placebo). Auriculotherapy is similar to methods used in acupuncture, but relies on an electrical current undetectable by the person, to stimulate prescribed points on the ear to facilitate smoking cessation.

The objectives for this pilot study are to:

  1. estimate sample size calculation for a larger trial
  2. determine the integrity and feasibility of study protocol
  3. test data collection forms
  4. test randomization procedure
  5. estimate consent rate and barriers to recruitment
  6. determine acceptability of auriculotherapy as an intervention for smoking cessation in the veteran population and
  7. determine reliability and feasibility of the primary outcome measure - smoking abstinence
Eligibility
Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
Locations
United States, Missouri
VA Medical Center, St Louis
St Louis, Missouri, United States, 63106 Principal Investigator: Deborah Jean Fritz, PhD

Information obtained from ClinicalTrials.gov on September 22, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01189110

Study ID Number: NRI 08-371

ClinicalTrials.gov Identifier: NCT01189110

Health Authority: United States: Federal Government

http://clinicaltrials.gov/show/NCT01189110


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