Auriculotherapy for Smoking Cessation: Pilot

NCT01189110 | Completed Results DMC

• 1 other identifier: NRI 08-371
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Keywords

smoking cessation; veterans; auriculotherapy

Outcome Measures

Primary Outcomes (1)

• Percentage of Self-reported Abstinence at 6 Weeks.

  Percentage of study participants free from smoking at 6 weeks based on self-report (yes/no).

  6 weeks

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

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

Arm 2

PLACEBO COMPARATOR

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

Interventions

Auriculotherapy using TENS unit Stim Flex 400A DEVICE

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

Arm 1; Arm 2

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

St. Louis VA Medical Center John Cochran Division, St. Louis, MO

St Louis, Missouri, 63106, United States

Location

Related Publications (1)

• 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.

  PMID: 23288282 RESULT

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Limitations and Caveats

It is possible that the pressure alone applied to these points provided a therapeutic effect and therefore was not a true placebo. Other stimulation frequencies or intensities may have produced a different outcome condition.

Results Point of Contact

• Title: Deborah Fritz FNP PhD
• Organization: VAMC St. Louis MO

deborah.fritz@va.gov

314-652-4100

Study Officials

• Deborah Jean Fritz, PhD

  St. Louis VA Medical Center John Cochran Division, St. Louis, MO

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2010
• First Posted: August 26, 2010
• Study Start: August 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: June 1, 2011
• Last Updated: April 28, 2015
• Results First Posted: April 15, 2014

Record last verified: 2013-08

Locations

US (1)