Auriculotherapy for Smoking Cessation: Pilot

• 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: US Department of Veterans Affairs
• Information provided by (Responsible Party): VA Office of Research and Development ( US Department of Veterans Affairs )

Tracking Information

• First Submitted Date: August 24, 2010
• First Posted Date: August 26, 2010
• Results First Submitted Date: September 30, 2013
• Results First Posted Date: April 15, 2014
• Last Update Posted Date: April 28, 2015
• Study Start Date: August 2010
• Actual Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 18, 2014)

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).

• Original Primary Outcome Measures (submitted: August 24, 2010): smoking abstinence [ Time Frame: 6 weeks ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Auriculotherapy for Smoking Cessation: Pilot
• Official Title: Auriculotherapy for Smoking Cessation
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Smoking Cessation

Intervention

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

Study Arms

• Active Comparator: Arm 1
  Stimulation of auriculotherapy points on both ears with functioning Stim Flex 400A TENS unit once a week for 5 weeks.
  Intervention: Device: Auriculotherapy using TENS unit Stim Flex 400A
• Placebo Comparator: Arm 2
  Stimulation of auriculotherapy points on both ears with disabled Stim Flex 400A TENS unit once a week for 5 weeks.
  Intervention: Device: Auriculotherapy using TENS unit Stim Flex 400A

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 24, 2010): 125
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: June 2011
• Actual Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 19 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01189110
• Other Study ID Numbers: NRI 08-371
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
• Study Sponsor: US Department of Veterans Affairs
• Collaborators: Not Provided

Investigators

• Principal Investigator: Deborah Jean Fritz, PhD; St. Louis VA Medical Center John Cochran Division, St. Louis, MO

• PRS Account: VA Office of Research and Development
• Verification Date: August 2013