Anticipated Impacts on Veteran's Healthcare: 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. The most effective way to eliminate smoking-related illness is, for those who already smoke, to discontinue tobacco use. Smoking cessation reduces the risk of many conditions associated with smoking. This pilot study will attempt 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. Project Background: Some veterans may not respond well to current standard treatments, or they may have contraindications to nicotine patch or bupropion. In addition, veterans tend to have more co-morbid medical conditions and require higher levels of polypharmacy than many groups. Adding more drugs to an already complicated treatment regimen increases the risk for drug-drug interactions, and may compromise adherence to other medications. Despite its popularity, minimal research has been done with auriculotherapy, so that no firm conclusions concerning its effectiveness can be drawn. Therefore, a controlled study of this popular treatment is badly needed. Project Objectives for this pilot study are to: 1)determine sample size calculation for a larger trial, 2)trial integrity and feasibility of study protocol, 3)test data collection forms, 4)test randomization procedure, 5) determine consent rate and barriers to recruitment, 6) determine acceptability of auriculotherapy as an intervention for smoking cessation in the veteran population and 7)determine reliability and feasibility of the primary outcome measure - smoking abstinence Project methods: This pilot study will take place at the VAMC, in conjunction with the smoking cessation clinic. One hundred twenty five veterans, male and female, age 19 or older, who smoke a minimum of 10 cigarettes per day, will be evaluated for enrollment with 50 participants in each group completing at least 6 weeks of the trial. Baseline and follow up assessments will be conducted for smoking activity, and nicotine dependence, using self report and sputum cotinine level. Other key variables include level of depression (PHQ-9), and level of perceived stress (PSS-4) which may impact vet's ability to achieve smoking cessation. Follow up measures of withdrawal symptoms (MNWS), treatment side effects and general overall rating by veterans will support the acceptability of auriculotherapy as an intervention. Appropriate statistical methods will be utilized.
This proposed pilot study will encourage methodological rigor and will lead to a higher quality clinical trial for a future double-blind, placebo controlled clinical trial of auriculotherapy for smoking cessation, which has never been undertaken with veterans. Pilot data will assist in determining sample size, feasibility, and acceptability of auriculotherapy as an intervention for smoking cessation in the veteran population. As a result of this research, we eventually hope to add auriculotherapy as an alternative, non pharmacologic intervention for achieving smoking cessation.
