Transdermal Electroacupuncture for Opioid Detoxification
Recruitment status was Active, not recruiting
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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 |
- relapse to opioids (measured by urine drug screen and timeline followback) [ Time Frame: 2 weeks following discharge ] [ Designated as safety issue: No ]
- 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 |
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| United States, Massachusetts | |
| McLean Hospital | |
| Belmont, Massachusetts, United States, 02478 | |
| 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 May 21, 2013