Overview

This trial is active, not recruiting.

Condition opioid dependency
Treatment electroacupuncture
Phase phase 1/phase 2
Sponsor Mclean Hospital
Collaborator Harvard University
Start date August 2007
End date October 2008
Trial size 60 participants
Trial identifier NCT00742170, 2007-P000711

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
In the active electroacupuncture condition, the current is set at 2 times threshold (approximately 6-10 mA), which typically produces muscle twitching.
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)
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.
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.

Primary Outcomes

Measure
relapse to opioids (measured by urine drug screen and timeline followback)
time frame: 2 weeks following discharge

Secondary Outcomes

Measure
opioid craving (self-report)
time frame: at discharge and 1- and 2-weeks post discharge

Eligibility Criteria

Male or female participants from 18 years up to 59 years old.

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

Additional Information

Official title Transdermal Electroacupuncture for Opioid Detoxification
Principal investigator Christina S Meade, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2008.
Information provided to ClinicalTrials.gov by Mclean Hospital.