Opioid-use DisorderPROUDNCT04244227
Pilot Research on Opioid Use Disorder
A study testing Empower Neuromodulation System in people with Opioid-use Disorder, run by Theranova, L.L.C. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- Empower Neuromodulation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2020to 15 Feb 2022
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Northern California Institute for Research and Education
San Francisco, California, 94121
About this study
Official title: Pilot Evaluation of the Empower Neuromodulation System in OUD Patients
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.
Read the 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
- Being tested
- Empower Neuromodulation System
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empower Neuromodulation SystemDevice
Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body.
| Study group | Role | What they receive |
|---|---|---|
| Active treatment | Experimental | 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. Receives: Device: Empower Neuromodulation System |
| Sham treatment | Sham comparator | 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. Receives: Device: Empower Neuromodulation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 weeks
Adverse events
Safety assessment via device-related adverse events.
Measured: 3 weeks
Secondary outcomes (4)
Opioid use
Number of positive outcomes in urine screening tests for opioids.
Measured: 3 weeks
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.
Measured: Week one of the 3-week study
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.
Measured: Week one of the 3-week study
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).
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start10 Mar 2020
- Primary completion15 Feb 2022 (estimated)
- Study completion15 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- At enrollment, participants will be randomized (1:1) to receive either the active or sham treatment for the duration of the 3-week study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theranova, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA), Northern California Institute of Research and Education
- Responsible party
- Sponsor
- Investigators
- Michael Vice President, Study director, Theranova, LLCEllen Principal Investigator, Principal investigator, Northern California Institute of Research and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244227
- Sponsor's protocol ID
- CRD-12-1209-01
- Other IDs
- R43DA049623
- Acronym
- PROUD
- Status last verified
- Feb 2022
- First submitted
- 23 Jan 2020
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Evaluation of the Empower Neuromodulation System in OUD Patients
- ClinicalTrials.gov ID
- NCT04244227
- Acronym / sponsor ID
- PROUD / CRD-12-1209-01
- Conditions
- Opioid-use Disorder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Theranova, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA), Northern California Institute of Research and Education
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 15 Feb 2022 (estimated)
- Study completion
- 15 Feb 2022 (estimated)
- First posted
- 28 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- At enrollment, participants will be randomized (1:1) to receive either the active or sham treatment for the duration of the 3-week study.
| Arm | Type | Receives |
|---|---|---|
| Active treatment | Experimental | Device: Empower Neuromodulation SystemParticipants 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. |
| Sham treatment | Sham comparator | Device: Empower Neuromodulation SystemParticipants 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empower Neuromodulation SystemPeripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body. | Device | Active treatment, Sham treatment |
Primary outcome
Opioid craving intensity
Time frame: 3 weeks
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).
Adverse events
Time frame: 3 weeks
Safety assessment via device-related adverse events.
4 secondary outcomes
Opioid use
Time frame: 3 weeks
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).
Time frame: Week one of the 3-week study
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).
Time frame: Week one of the 3-week study
System usability scale (SUS)
Time frame: 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Vice President study director
Theranova, LLC
Ellen Principal Investigator principal investigator
Northern California Institute of Research and Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empower Neuromodulation System in people with Opioid-use Disorder, run by Theranova, L.L.C. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid craving intensity (time frame: 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2022.