Trial Outcomes & Findings for Transdermal Electroacupuncture for Opioid Detoxification (NCT NCT00742170)

NCT ID: NCT00742170

Last Updated: 2014-10-21

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 48 participants
• Primary outcome timeframe: 2 weeks following discharge
• Results posted on: 2014-10-21

Participant Flow

Participant milestones

Measure	Active Electroacupuncture Condition Active electroacupuncture condition Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification.	Sham Electroacupuncture Condition In the sham electroacupuncture condition, the current is set at 1 mA, the lowest intensity possible before the HANS device shuts off; this is undetectable stimulation. Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification.
Overall Study STARTED	26	29
Overall Study COMPLETED	24	24
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Transdermal Electroacupuncture for Opioid Detoxification

Baseline characteristics by cohort

Measure	Active Stimulation n=26 Participants In the active electroacupuncture condition, the current is set at 2 times threshold (approximately 6-10 mA), which typically produces muscle twitching. Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification.	Sham Stimulation n=29 Participants In the sham electroacupuncture condition, the current is set at 1 mA, the lowest intensity possible before the HANS device shuts off; this is undetectable stimulation. Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification.	Total n=55 Participants Total of all reporting groups
Age, Continuous	27.7 years STANDARD_DEVIATION 8.9 • n=5 Participants	27.0 years STANDARD_DEVIATION 8.6 • n=7 Participants	27.4 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	21 Participants n=7 Participants	39 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants	28 Participants n=7 Participants	51 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants	27 Participants n=7 Participants	52 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants	29 participants n=7 Participants	55 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks following discharge

Outcome measures

Measure	Active Stimulation n=17 Participants In the active electroacupuncture condition, the current is set at 2 times threshold (approximately 6-10 mA), which typically produces muscle twitching. Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification.	Sham Stimulation n=17 Participants In the sham electroacupuncture condition, the current is set at 1 mA, the lowest intensity possible before the HANS device shuts off; this is undetectable stimulation. Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification.
Percent of Participants Using Drugs	35 percent	77 percent

SECONDARY outcome

Timeframe: at 2-weeks post discharge

Self-report on scale of 3 to 30 (higher number indicates more craving)

Outcome measures

Measure	Active Stimulation n=17 Participants In the active electroacupuncture condition, the current is set at 2 times threshold (approximately 6-10 mA), which typically produces muscle twitching. Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification.	Sham Stimulation n=17 Participants In the sham electroacupuncture condition, the current is set at 1 mA, the lowest intensity possible before the HANS device shuts off; this is undetectable stimulation. Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification.
Opioid Craving (Self-report)	10.7 units on a scale Standard Deviation 7.2	14.3 units on a scale Standard Deviation 6.9

Adverse Events

Active Stimulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham Stimulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Scott E. Lukas, Ph.D.

McLean Hospital

Phone: 617-855-2767

Email: slukas@mclean.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place