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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator | Stimulation of auriculotherapy points on both ears with functioning Stim Flex 400A TENS unit once a week for 5 weeks. |
|
| Arm 2 | Placebo Comparator | Stimulation of auriculotherapy points on both ears with disabled Stim Flex 400A TENS unit once a week for 5 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Veterans will be excluded from the study if they:
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| Name | Affiliation | Role |
|---|---|---|
| Deborah Jean Fritz, PhD | St. Louis VA Medical Center John Cochran Division, St. Louis, MO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Louis VA Medical Center John Cochran Division, St. Louis, MO | St Louis | Missouri | 63106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23288282 | Result | 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. |
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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 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 | Intervention- true Stim Flex treatment |
| FG001 | Arm 2 | Placebo group- sham Stim Flex machine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Demographic data, smoking history, fagerstrom nicotine dependence, stage of change, PHQ-9, Percieved stress scale, Minnesota withdrawal scale
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 6 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1- Intervention | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hospitalization | Psychiatric disorders | Systematic Assessment | one hospitalization for psychiatric reasons not related to study |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deborah Fritz FNP PhD | VAMC St. Louis MO | 314-652-4100 | 53692 | deborah.fritz@va.gov |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
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| 2 |
| 64 |
| 0 |
| 64 |
| EG001 | Arm 2- Placebo | 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. | 0 | 61 | 0 | 61 |
|
| hospitalization | Renal and urinary disorders | urinary tract infect | Systematic Assessment |
|
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