Transdermal Electroacupuncture for Opioid Detoxification
Condition: Opioid Dependency
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This single-blind, randomized clinical trial tests whether electroacupuncture, provided as an
      adjunctive treatment, improves outcomes among patients receiving inpatient opioid
      detoxification from opioids.
    

Detailed description: 
      Opioid dependence continues to be a major public health concern in the United States, with
      prescription opioid abuse rapidly becoming one of the nation's biggest drug problems.
      Although there have been substantial improvements in the pharmacological treatment of opioid
      dependence, many patients relapse soon after detoxification. In China and other countries,
      acupuncture has been effective in the treatment of heroin dependence. The current study tests
      whether electroacupuncture, provided as an adjunctive treatment, produces improved outcomes
      among patients receiving inpatient detoxification from opioids. The primary hypothesis is
      that participants who receive active electroacupuncture, compared to those receiving sham
      electroacupuncture, will experience milder withdrawal symptoms, report less opioid craving,
      and maintain abstinence from opioids for longer duration following discharge. This study will
      be a single-blind, randomized clinical trial in which participants will receive either active
      or sham electroacupuncture. Participants will be recruited from the inpatient unit at the
      Alcohol and Drug Abuse Treatment Program at McLean Hospital. Participants will receive thrice
      daily 30-minute electroacupuncture treatments for 4 days. The Han's Acupoint Nerve Stimulator
      device will be used to stimulate acupoints on one hand (LI4/P8) and opposite arm (P6/TE5).
      This device emits a constant electric current transcutaneously via skin electrodes to
      stimulate relevant acupoints. It does not use needles and has no harmful side-effects.
      Participants will be followed for 2 weeks following discharge. Assessments will occur daily
      during the treatment phase and weekly during the follow-up phase. Assessments will include
      clinical interviews, questionnaires, urine toxicology screens, and medical record review. The
      results of this study will indicate whether short-term electroacupuncture may be of benefit
      to individuals receiving inpatient detoxification from opioids.
    

Intervention name(s): Electroacupuncture
Intervention type(s): Device
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: opioid dependence; opioid detoxification; electroacupuncture; adjunctive treatment; alternative/complementary medicine