NCT00742170

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2007

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

October 21, 2014

Completed
Last Updated

October 21, 2014

Status Verified

October 1, 2014

Enrollment Period

2.2 years

First QC Date

August 25, 2008

Results QC Date

October 15, 2014

Last Update Submit

October 15, 2014

Conditions

Opioid Dependency

Keywords

opioid dependenceopioid detoxificationelectroacupunctureadjunctive treatmentalternative/complementary medicine

Outcome Measures

Primary Outcomes (1)

  • Percent of Participants Using Drugs

    2 weeks following discharge

Secondary Outcomes (1)

  • Opioid Craving (Self-report)

    at 2-weeks post discharge

Study Arms (2)

Active electroacupuncture

ACTIVE COMPARATOR

In the active electroacupuncture condition, the current is set at 2 times threshold (approximately 6-10 mA), which typically produces muscle twitching.

Device: Electroacupuncture

Sham electroacupuncture

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.

Device: Electroacupuncture

Interventions

ElectroacupunctureDEVICE

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.

Active electroacupunctureSham electroacupuncture

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Current opioid dependence
  • Current buprenorphine detoxification
  • years of age
  • English proficiency

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Related 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.

    PMID: 19574017BACKGROUND

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsAcupuncture TherapyComplementary TherapiesElectric Stimulation TherapyPhysical Therapy ModalitiesRehabilitationTranscutaneous Electric Nerve StimulationAnalgesiaAnesthesia and AnalgesiaAnesthesia

Results Point of Contact

Title
Scott E. Lukas, Ph.D.
Organization
McLean Hospital
slukas@mclean.harvard.edu
617-855-2767

Study Officials

  • Scott E Lukas, PhD

    Mclean Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pharmacologist

Study Record Dates

First Submitted

August 25, 2008

First Posted

August 27, 2008

Study Start

August 1, 2007

Primary Completion

October 1, 2009

Study Completion

January 1, 2010

Last Updated

October 21, 2014

Results First Posted

October 21, 2014

Record last verified: 2014-10

Locations

US(1)