Trial Outcomes & Findings for Auriculotherapy for Smoking Cessation: Pilot (NCT NCT01189110)
NCT ID: NCT01189110
Last Updated: 2015-04-28
Results Overview
Percentage of study participants free from smoking at 6 weeks based on self-report (yes/no).
COMPLETED
NA
125 participants
6 weeks
2015-04-28
Participant Flow
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.
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.
Participant milestones
| Measure |
Arm 1
Intervention- true Stim Flex treatment
|
Arm 2
Placebo group- sham Stim Flex machine
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
61
|
|
Overall Study
COMPLETED
|
64
|
61
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Auriculotherapy for Smoking Cessation: Pilot
Baseline characteristics by cohort
| Measure |
Arm 1
n=64 Participants
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.
|
Arm 2
n=61 Participants
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
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
64 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
55.3 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
55.8 years
STANDARD_DEVIATION 10 • n=7 Participants
|
55.5 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
64 participants
n=5 Participants
|
61 participants
n=7 Participants
|
125 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: 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.
Percentage of study participants free from smoking at 6 weeks based on self-report (yes/no).
Outcome measures
| Measure |
Arm 1- Intervention
n=64 Participants
Receipt of auriculotherapy via a Stim Flex machine that provided full electrical flow of current to the ear probe.
|
Arm 2- Placebo
n=61 Participants
Receipt of sham auriculotherapy via a Stim Flex machine that disabled electrical flow of current to the ear probe.
|
|---|---|---|
|
Percentage of Self-reported Abstinence at 6 Weeks.
|
12.3 percentage of participants
Interval 4.0 to 20.7
|
12.9 percentage of participants
Interval 4.0 to 21.7
|
Adverse Events
Arm 2- Placebo
Arm 1- Intervention
Serious adverse events
| Measure |
Arm 2- Placebo
n=61 participants at risk
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.
|
Arm 1- Intervention
n=64 participants at risk
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.
|
|---|---|---|
|
Psychiatric disorders
hospitalization
|
0.00%
0/61
|
1.6%
1/64 • Number of events 1
|
|
Renal and urinary disorders
hospitalization
|
0.00%
0/61
|
1.6%
1/64 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place