Opioid Dependency
Conditions
Keywords
opioid dependence, opioid detoxification, electroacupuncture, adjunctive treatment, alternative/complementary medicine
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.
Interventions
DEVICEElectroacupuncture
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.
Sponsors
Harvard Medical School (HMS and HSDM)
Mclean Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent of Participants Using Drugs | 2 weeks following discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Craving (Self-report) | at 2-weeks post discharge | Self-report on scale of 3 to 30 (higher number indicates more craving) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Stimulation 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. | 26 |
| Sham Stimulation 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. | 29 |
| Total | 55 |
Baseline characteristics
| Characteristic | Total | Active Stimulation | Sham Stimulation |
|---|---|---|---|
| Age, Continuous | 27.4 years STANDARD_DEVIATION 8.7 | 27.7 years STANDARD_DEVIATION 8.9 | 27.0 years STANDARD_DEVIATION 8.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 52 Participants | 25 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 51 Participants | 23 Participants | 28 Participants |
| Region of Enrollment United States | 55 participants | 26 participants | 29 participants |
| Sex: Female, Male Female | 16 Participants | 8 Participants | 8 Participants |
| Sex: Female, Male Male | 39 Participants | 18 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 26 | 0 / 29 |
| serious Total, serious adverse events | 0 / 26 | 0 / 29 |
Outcome results
Primary
Percent of Participants Using Drugs
Time frame: 2 weeks following discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active Stimulation | Percent of Participants Using Drugs | 35 percent |
| Sham Stimulation | Percent of Participants Using Drugs | 77 percent |
Secondary
Opioid Craving (Self-report)
Self-report on scale of 3 to 30 (higher number indicates more craving)
Time frame: at 2-weeks post discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Stimulation | Opioid Craving (Self-report) | 10.7 units on a scale | Standard Deviation 7.2 |
| Sham Stimulation | Opioid Craving (Self-report) | 14.3 units on a scale | Standard Deviation 6.9 |