N/A
Completed N=125
Auriculotherapy for Smoking Cessation: Pilot
Source: ClinicalTrials.gov NCT01189110 ↗Enrolled (actual)
125
Serious AEs
1.6%
Results posted
Apr 2014
Primary outcomePrimary: Percentage of Self-reported Abstinence at 6 Weeks. — 12.3; 12.9 percentage of participants — p=0.74
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Self-reported Abstinence at 6 Weeks. |
12.3; 12.9 | 0.74 |
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.
Data sourced from ClinicalTrials.gov (NCT01189110). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.