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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

August 25, 2008
October 15, 2014
August 2007
October 2009   (final data collection date for primary outcome measure)
Percent of Participants Using Drugs [ Time Frame: 2 weeks following discharge ] [ Designated as safety issue: No ]
relapse to opioids (measured by urine drug screen and timeline followback) [ Time Frame: 2 weeks following discharge ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00742170 on ClinicalTrials.gov Archive Site
Opioid Craving (Self-report) [ Time Frame: at 2-weeks post discharge ] [ Designated as safety issue: No ]
Self-report on scale of 3 to 30 (higher number indicates more craving)
opioid craving (self-report) [ Time Frame: at discharge and 1- and 2-weeks post discharge ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Transdermal Electroacupuncture for Opioid Detoxification
Transdermal Electroacupuncture for Opioid Detoxification

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

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Opioid Dependency
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.
  • 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.
    Intervention: Device: Electroacupuncture
  • 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.
    Intervention: Device: Electroacupuncture
Meade CS, Lukas SE, McDonald LJ, Fitzmaurice GM, Eldridge JA, Merrill N, Weiss RD. A randomized trial of transcutaneous electric acupoint stimulation as adjunctive treatment for opioid detoxification. J Subst Abuse Treat. 2010 Jan;38(1):12-21. Epub 2009 Jul 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
January 2010
October 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 59 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00742170
2007-P000711
No
Scott Lukas, Mclean Hospital
Mclean Hospital
Harvard Medical School
Principal Investigator: Scott E Lukas, PhD Mclean Hospital
Mclean Hospital
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP