Transdermal Electroacupuncture for Opioid Detoxification

Opioid Dependency Clinical Trial

Official title:

Transdermal Electroacupuncture for Opioid Detoxification

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00742170
• Other study ID #: 2007-P000711
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 25, 2008
• Last updated: October 15, 2014
• Start date: August 2007
• Est. completion date: January 2010

Study information

• Verified date: October 2014
• Source: Mclean Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 59 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opioid Dependency

Intervention

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.

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Mclean Hospital	Harvard Medical School

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. doi: 10.1016/j.jsat.2009.05.010. Epub 2009 Jul 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Participants Using Drugs		2 weeks following discharge	No
Secondary	Opioid Craving (Self-report)	Self-report on scale of 3 to 30 (higher number indicates more craving)	at 2-weeks post discharge	No