Pilot Research on Opioid Use Disorder

Opioid-use Disorder Clinical Trial

— PROUD  

Official title:

Pilot Evaluation of the Empower Neuromodulation System in OUD Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04244227
• Other study ID #: CRD-12-1209-01
• Secondary ID: R43DA049623
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 10, 2020
• Est. completion date: February 15, 2022

Study information

• Verified date: February 2022
• Source: Theranova, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: February 15, 2022
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Northern California Institute for Research and Education	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
Theranova, L.L.C.	National Institute on Drug Abuse (NIDA), Northern California Institute of Research and Education

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid craving intensity	Self-reported opioid craving intensity via daily 100-mm visual-analog scale (VAS). The VAS has a minimum score of 0 (no craving) and a maximum score of 100 (severe craving).	3 weeks
Primary	Adverse events	Safety assessment via device-related adverse events.	3 weeks
Secondary	Opioid use	Number of positive outcomes in urine screening tests for opioids.	3 weeks
Secondary	Clinical opioid withdrawal scale (COWS). The COWS is an 11-item, clinician-administered tool that measures a patient's withdrawal symptoms. The COWS has a minimum score of 0 (no withdrawal) and a maximum score of 48 (severe withdrawal).	Change in COWS score.	Week one of the 3-week study
Secondary	Subjective opioid withdrawal scale (SOWS). The SOWS is an 16-item, self-reported questionnaire that measures a patient's withdrawal symptoms. The SOWS has a minimum score of 0 (no withdrawal) and a maximum score of 64 (severe withdrawal).	Change in SOWS score.	Week one of the 3-week study
Secondary	System usability scale (SUS)	Self-reported assessment of system usability. The SUS is a 10-item, self-reported questionnaire that measures usability of the system. The SUS has a minimum score of 0 (extremely poor usability) and a maximum score of 100 (excellent usability).	3 weeks