Pilot Research on Opioid Use Disorder

NCT ID: NCT04244227

Last Updated: 2022-02-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-10
• Study Completion Date: 2022-02-15

Brief Summary

This study evaluates the effects of peripheral nerve stimulation on opioid withdrawal, craving, and use in participants with opioid use disorder (OUD) who are initiating treatment with buprenorphine/naloxone. This is a pilot investigation in which participants will randomized (1:1) to the active or sham treatment.

Detailed Description

Opioid use disorder (OUD) has become a public health emergency. Approximately 2.6 million Americans suffered from OUD in 2016. Evidence-based approaches for treating OUD include several medication-assisted treatments (MATs). While MATs are effective at reducing illicit opioid use and overdose deaths, it is well-established that withdrawal and craving are key contributors to treatment dropout, relapse, and overdose. Peripheral nerve stimulation via acupuncture has been shown to directly decrease drug withdrawal, craving, and self-administration. The investigators have developed the Empower Neuromodulation System, a non-invasive, portable transcutaneous electrical nerve stimulation (TENS) device intended to stimulate peripheral nerves for the treatment of OUD. In this study, a randomized, controlled study will be conducted in participants with OUD who are initiating treatment with buprenorphine/naloxone. Participants will self-administer daily treatment with the Empower device. Endpoints will be evaluated for safety, effectiveness, and acceptability.

Conditions

Opioid-use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Active treatment

Participants will self-administer treatment with the Empower device at the active treatment anatomic location once daily for three weeks. Participants will complete daily and weekly surveys to evaluate the effects of the Empower active treatment.

Group Type: EXPERIMENTAL

Empower Neuromodulation System

Intervention Type: DEVICE

Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body.

Sham treatment

Participants will self-administer treatment with the Empower device at the sham treatment anatomic location once daily for three weeks. Participants will complete daily and weekly surveys to evaluate the effects of the Empower sham treatment.

Group Type: SHAM_COMPARATOR

Empower Neuromodulation System

Intervention Type: DEVICE

Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body.

Interventions

Empower Neuromodulation System

Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• VA-eligible Veterans
• Ages ≥ 18
• Current diagnosis of opioid use disorder per DSM-5 by clinician assessment
• Scheduled to initiate, or has initiated within the past five days, treatment for OUD with buprenorphine/naloxone

Exclusion Criteria

• Injury or nerve damage at the arm or palm and/or neuropathy in the upper extremities
• Pregnant or planning to become pregnant
• Currently implanted with an electrical and/or neurostimulator device (e.g. pacemaker, defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, sacral stimulator, bone growth stimulator, or cochlear implant)
• Use of an investigational drug/device therapy within the past 4 weeks
• History of epilepsy or a seizure disorder
• Has an electrically conductive metal object (e.g. jewelry) that cannot be removed and will directly contact the gel electrodes of the Empower Neuromodulation System when applied to the skin at the stimulation location
• Unable to provide informed written consent
• Has taken a medication-assisted treatment (MAT) for OUD in the past two weeks or plans to take any prescription opioid or MAT for OUD other than buprenorphine/naloxone while enrolled in the study
• Is deemed unsuitable for enrollment in the study by the PI (e.g. current medical or psychiatric instability)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Northern California Institute of Research and Education

OTHER

Sponsor Role: collaborator

Theranova, L.L.C.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Vice President

Role: STUDY_DIRECTOR

Theranova, LLC

Ellen Principal Investigator

Role: PRINCIPAL_INVESTIGATOR

Northern California Institute of Research and Education

Locations

Northern California Institute for Research and Education

San Francisco, California, United States

Countries

United States

Other Identifiers

R43DA049623

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CRD-12-1209-01

Identifier Type: -

Identifier Source: org_study_id