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Transdermal Electroacupuncture for Opioid Detoxification

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ClinicalTrials.gov Identifier: NCT00742170
Recruitment Status : Completed
First Posted : August 27, 2008
Results First Posted : October 21, 2014
Last Update Posted : October 21, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Opioid Dependency Device: Electroacupuncture Phase 1 Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Transdermal Electroacupuncture for Opioid Detoxification
Study Start Date : August 2007
Primary Completion Date : October 2009
Study Completion Date : January 2010
Arms and Interventions

Arm Intervention/treatment
Active Comparator: Active electroacupuncture
In the active electroacupuncture condition, the current is set at 2 times threshold (approximately 6-10 mA), which typically produces muscle twitching.
Device: 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 Comparator: Sham electroacupuncture
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.
Device: 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.


Outcome Measures

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

Secondary Outcome Measures :
  1. Opioid Craving (Self-report) [ Time Frame: at 2-weeks post discharge ]
    Self-report on scale of 3 to 30 (higher number indicates more craving)


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current opioid dependence
  • Current buprenorphine detoxification
  • 18-59 years of age
  • English proficiency

Exclusion Criteria:

  • Acute mania, psychosis, or suicidality
  • Cognitive impairments precluding informed consent
  • Heart disease or contraindicated heart condition
  • Use of pace maker
  • History of seizure disorder
  • Current detoxification from alcohol or benzodiazepines
  • Inability to return to follow-up visits
  • For women, pregnancy
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00742170


Locations
United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Mclean Hospital
Harvard Medical School
Investigators
Principal Investigator: Scott E Lukas, PhD Mclean Hospital
More Information

Publications:
Responsible Party: Scott Lukas, Pharmacologist, Mclean Hospital
ClinicalTrials.gov Identifier: NCT00742170     History of Changes
Other Study ID Numbers: 2007-P000711
First Posted: August 27, 2008    Key Record Dates
Results First Posted: October 21, 2014
Last Update Posted: October 21, 2014
Last Verified: October 2014

Keywords provided by Scott Lukas, Mclean Hospital:
opioid dependence
opioid detoxification
electroacupuncture
adjunctive treatment
alternative/complementary medicine

Additional relevant MeSH terms:
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents