Transdermal Electroacupuncture for Opioid Detoxification

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Mclean Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Harvard University
Information provided by:
Mclean Hospital
ClinicalTrials.gov Identifier:
NCT00742170
First received: August 25, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  Purpose

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 Intervention Phase
Opioid Dependency
Device: Electroacupuncture
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Transdermal Electroacupuncture for Opioid Detoxification

Further study details as provided by Mclean Hospital:

Primary Outcome Measures:
  • relapse to opioids (measured by urine drug screen and timeline followback) [ Time Frame: 2 weeks following discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • opioid craving (self-report) [ Time Frame: at discharge and 1- and 2-weeks post discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2007
Estimated Study Completion Date: October 2008
Estimated Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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: 2
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00742170

Locations
United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Mclean Hospital
Harvard University
Investigators
Principal Investigator: Christina S Meade, PhD Mclean Hospital
Study Director: Roger D Weiss, MD Mclean Hospital
Study Director: Scott E Lukas, PhD Mclean Hospital
  More Information

No publications provided by Mclean Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christina S. Meade, McLean Hospital/Harvard Medical School
ClinicalTrials.gov Identifier: NCT00742170     History of Changes
Other Study ID Numbers: 2007-P000711
Study First Received: August 25, 2008
Last Updated: August 25, 2008
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants

ClinicalTrials.gov processed this record on April 22, 2014