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Auriculotherapy for Smoking Cessation: Pilot

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01189110
Recruitment Status : Completed
First Posted : August 26, 2010
Results First Posted : April 15, 2014
Last Update Posted : April 28, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Device: Auriculotherapy using TENS unit Stim Flex 400A Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Auriculotherapy for Smoking Cessation
Study Start Date : August 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arm 1
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
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
Placebo Comparator: Arm 2
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
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


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Self-reported Abstinence at 6 Weeks. [ Time Frame: 6 weeks ]
    Percentage of study participants free from smoking at 6 weeks based on self-report (yes/no).


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01189110


Locations
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United States, Missouri
St. Louis VA Medical Center John Cochran Division, St. Louis, MO
St Louis, Missouri, United States, 63106
Sponsors and Collaborators
US Department of Veterans Affairs
Investigators
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Principal Investigator: Deborah Jean Fritz, PhD St. Louis VA Medical Center John Cochran Division, St. Louis, MO
More Information
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Publications of Results:

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Responsible Party: US Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01189110    
Other Study ID Numbers: NRI 08-371
First Posted: August 26, 2010    Key Record Dates
Results First Posted: April 15, 2014
Last Update Posted: April 28, 2015
Last Verified: August 2013
Keywords provided by VA Office of Research and Development ( US Department of Veterans Affairs ):
smoking cessation
veterans
auriculotherapy