Clinical trial NCT00742170: Transdermal Electroacupuncture for Opioid Detoxification
Official title: Transdermal Electroacupuncture for Opioid Detoxification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Opioid Dependency
Keywords: opioid dependence
opioid detoxification
electroacupuncture
adjunctive treatment
alternative/complementary medicine
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
Collaborators: name: Harvard Medical School (HMS and HSDM)
First posted: 2008-08-27
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Percent of Participants Using Drugs
timeFrame: 2 weeks following discharge
Secondary outcomes:
measure: Opioid Craving (Self-report)
timeFrame: at 2-weeks post discharge
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: Scott E Lukas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.