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Auriculotherapy for Smoking Cessation: Pilot

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01189110
First Posted: August 26, 2010
Last Update Posted: April 28, 2015
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.
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
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 Intervention
Smoking Cessation Device: Auriculotherapy using TENS unit Stim Flex 400A

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Auriculotherapy for Smoking Cessation

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • 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).


Enrollment: 125
Study Start Date: August 2010
Study Completion Date: June 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years and older   (Adult, Senior)
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
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
United States, Missouri
St. Louis VA Medical Center John Cochran Division, St. Louis, MO
St Louis, Missouri, United States, 63106
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Deborah Jean Fritz, PhD St. Louis VA Medical Center John Cochran Division, St. Louis, MO
  More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01189110     History of Changes
Other Study ID Numbers: NRI 08-371
First Submitted: August 24, 2010
First Posted: August 26, 2010
Results First Submitted: September 30, 2013
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:
smoking cessation
veterans
auriculotherapy