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Transdermal Electroacupuncture for Opioid Detoxification

This study has been completed.
Sponsor:
Collaborator:
Harvard Medical School
Information provided by (Responsible Party):
Scott Lukas, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT00742170
First received: August 25, 2008
Last updated: October 15, 2014
Last verified: October 2014
Results First Received: October 15, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Opioid Dependency
Intervention: Device: Electroacupuncture

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Active Electroacupuncture Condition     Sham Electroacupuncture Condition  
STARTED     26     29  
COMPLETED     24     24  
NOT COMPLETED     2     5  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Active Stimulation

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

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 Total of all reporting groups

Baseline Measures
    Active Stimulation     Sham Stimulation     Total  
Number of Participants  
[units: participants]
  26     29     55  
Age  
[units: years]
Mean ± Standard Deviation
  27.7  ± 8.9     27.0  ± 8.6     27.4  ± 8.7  
Gender  
[units: participants]
     
Female     8     8     16  
Male     18     21     39  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     1     1     2  
Asian     2     0     2  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     0     0  
White     23     28     51  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     1     2     3  
Not Hispanic or Latino     25     27     52  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     26     29     55  



  Outcome Measures
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1.  Primary:   Percent of Participants Using Drugs   [ Time Frame: 2 weeks following discharge ]

2.  Secondary:   Opioid Craving (Self-report)   [ Time Frame: at 2-weeks post discharge ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Scott E. Lukas, Ph.D.
Organization: McLean Hospital
phone: 617-855-2767
e-mail: slukas@mclean.harvard.edu


Publications:

Responsible Party: Scott Lukas, Mclean Hospital
ClinicalTrials.gov Identifier: NCT00742170     History of Changes
Other Study ID Numbers: 2007-P000711
Study First Received: August 25, 2008
Results First Received: October 15, 2014
Last Updated: October 15, 2014
Health Authority: United States: Institutional Review Board