Smoking Cessation
Conditions
Keywords
smoking cessation, veterans, auriculotherapy
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.
Interventions
DEVICEAuriculotherapy 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
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Do not meet any
Exclusion criteria
; age 19 and above.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Self-reported Abstinence at 6 Weeks. | 6 weeks | Percentage of study participants free from smoking at 6 weeks based on self-report (yes/no). |
Countries
United States
Participant flow
Recruitment details
Participants were recruited between August 2010 and January 2011 at the St. Louis VA. The inclusion criteria were age 19 years or older and currently smoking ≥10 cigarettes per day. Two hundred thirteen veterans who either responded to a mailing or were referred by their primary care physician expressed interest in the study.
Pre-assignment details
Seventeen were excluded due to eligibility criteria. The remaining 196 were scheduled to attend a 1-hour smoking cessation class. Twenty-nine did not attend. Eleven did not keep the consent appointment. Another 31 did not enroll for other reasons. Thus, 125 participants were randomized: 64 to the intervention group and 61 to the placebo group.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 Two separate Stim Flex machines will be used in this study: Machine A (usual care) will be a usual functioning machine which is FDA approved; Machine B (sham treatment) will be altered to disable the electrical current to flow to the probe. Otherwise both machines will be identical and function identical except at the time the electrical current is given thru the probe. There is no alteration to the outside of either Stem Flex machines, the alteration to the sham machine will be internal, and will appear and sound identical to the Stim Flex machine which has not been altered. | 64 |
| Arm 2 Machine B (sham treatment) will be altered to disable the electrical current to flow to the probe. Otherwise both machines will be identical and function identical except at the time the electrical current is given thru the probe. There is no alteration to the outside of either Stem Flex machines, the alteration to the sham machine will be internal, and will appear and sound identical to the Stim Flex machine which has not been altered. | 61 |
| Total | 125 |
Baseline characteristics
| Characteristic | Arm 2 | Total | Arm 1 |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 61 Participants | 125 Participants | 64 Participants |
| Age, Continuous | 55.8 years STANDARD_DEVIATION 10 | 55.5 years STANDARD_DEVIATION 9.5 | 55.3 years STANDARD_DEVIATION 9.1 |
| Region of Enrollment United States | 61 participants | 125 participants | 64 participants |
| Sex: Female, Male Female | 14 Participants | 30 Participants | 16 Participants |
| Sex: Female, Male Male | 47 Participants | 95 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 64 | 0 / 61 |
| serious Total, serious adverse events | 2 / 64 | 0 / 61 |
Outcome results
Primary
Percentage of Self-reported Abstinence at 6 Weeks.
Percentage of study participants free from smoking at 6 weeks based on self-report (yes/no).
Time frame: 6 weeks
Population: A middle-aged, US military veteran population not free of smoking (at least 10 cigarettes per day) and not currently in reciept of any other form of smoking cessation intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1- Intervention | Percentage of Self-reported Abstinence at 6 Weeks. | 12.3 percentage of participants |
| Arm 2- Placebo | Percentage of Self-reported Abstinence at 6 Weeks. | 12.9 percentage of participants |
Comparison: A two-proportion z-test was used to compare the proportion of self-reported abstinence at 3 weeks between groups.p-value: 0.7495% CI: [0.23, 2.83]Chi-squared