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Auriculotherapy for Smoking Cessation: Pilot

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01189110
Recruitment Status : Completed
First Posted : August 26, 2010
Results First Posted : April 15, 2014
Last Update Posted : April 28, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Smoking Cessation
Intervention Device: Auriculotherapy using TENS unit Stim Flex 400A
Enrollment 125
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.
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description Intervention- true Stim Flex treatment Placebo group- sham Stim Flex machine
Period Title: Overall Study
Started 64 [1] 61
Completed 64 [2] 61
Not Completed 0 0
[1]
September, 2010
[2]
February, 2011
Arm/Group Title Arm 1 Arm 2 Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 64 61 125
Hide Baseline Analysis Population Description
Demographic data, smoking history, fagerstrom nicotine dependence, stage of change, PHQ-9, Percieved stress scale, Minnesota withdrawal scale
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 61 participants 125 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
64
 100.0%
61
 100.0%
125
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 64 participants 61 participants 125 participants
55.3  (9.1) 55.8  (10) 55.5  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 61 participants 125 participants
Female
16
  25.0%
14
  23.0%
30
  24.0%
Male
48
  75.0%
47
  77.0%
95
  76.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 64 participants 61 participants 125 participants
64 61 125
1.Primary Outcome
Title Percentage of Self-reported Abstinence at 6 Weeks.
Hide Description Percentage of study participants free from smoking at 6 weeks based on self-report (yes/no).
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Arm 1- Intervention Arm 2- Placebo
Hide Arm/Group Description:
Receipt of auriculotherapy via a Stim Flex machine that provided full electrical flow of current to the ear probe.
Receipt of sham auriculotherapy via a Stim Flex machine that disabled electrical flow of current to the ear probe.
Overall Number of Participants Analyzed 64 61
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
12.3
(4.0 to 20.7)
12.9
(4.0 to 21.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1- Intervention, Arm 2- Placebo
Comments A two-proportion z-test was used to compare the proportion of self-reported abstinence at 3 weeks between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.74
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.81
Confidence Interval (2-Sided) 95%
0.23 to 2.83
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.42
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1- Intervention Arm 2- Placebo
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Arm 1- Intervention Arm 2- Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Arm 1- Intervention Arm 2- Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/64 (3.13%)      0/61 (0.00%)    
Psychiatric disorders     
hospitalization  [1]  1/64 (1.56%)  1 0/61 (0.00%)  0
Renal and urinary disorders     
hospitalization  1  1/64 (1.56%)  1 0/61 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, urinary tract infect
[1]
one hospitalization for psychiatric reasons not related to study
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Arm 1- Intervention Arm 2- Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/64 (0.00%)      0/61 (0.00%)    

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.

Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Deborah Fritz FNP PhD
Organization: VAMC St. Louis MO
Phone: 314-652-4100 ext 53692
EMail: deborah.fritz@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT01189110    
Other Study ID Numbers: NRI 08-371
First Submitted: August 24, 2010
First Posted: August 26, 2010
Results First Submitted: September 30, 2013
Results First Posted: April 15, 2014
Last Update Posted: April 28, 2015