Last reviewed · How we verify
NCT04244227: PROUD
Pilot Research on Opioid Use Disorder
NA trial testing Empower Neuromodulation System in Opioid-use Disorder in 10 participants. Participants enrolled and being followed up; not accepting new ones.
15 February 2022
Quick facts
| Lead sponsor | Theranova, L.L.C. |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 10 March 2020 |
| Primary completion | 15 February 2022 |
| Estimated completion | 15 February 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Empower Neuromodulation System
Conditions studied
- Opioid-use Disorder — all drugs for Opioid-use Disorder →
Sponsor
Theranova, L.L.C.
Who can join
Adults 18 to 100, any sex, with Opioid-use Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04244227
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Empower Neuromodulation System
Trials testing the same drug.
- NCT05948605 — EMPOWER AUD Pivotal Trial · NA · completed
- NCT04901481 — Empower Neuromodulation System - Pilot Study for Anxiety Treatment · NA · terminated
- NCT03983317 — Pilot Evaluation of the Empower Neuromodulation System in AUD Patients · NA · completed
Other recruiting trials for Opioid-use Disorder
Currently open trials in the same condition.
- NCT04783558 — Effective Caregiving for Neonatal Abstinence Syndrome: Testing an Instructional Mobile Technology Platform for High-Risk · NA · active not recruiting
- NCT05011266 — Efficacy of Buprenorphine and XR-Naltrexone Combination for Relapse Prevention in Opioid Use Disorder · Phase 2, PHASE3 · recruiting
- NCT05039554 — Randomized Trial of ACT and a Care Management App in Primary Care-based Buprenorphine Treatment · NA · recruiting
- NCT05033028 — Smartphones for Opiate Addiction Recovery · Phase 3 · recruiting
- NCT04738825 — Promoting HIV Risk Reduction Among People Who Inject Drugs: A Stepped Care Approach Using Contingency Management With Pr · NA · recruiting
Other Theranova, L.L.C. trials
Trials by the same sponsor.
- NCT06760572 — Airway Data Collection With the Entarik Feeding Tube System · NA · recruiting
- NCT05948605 — EMPOWER AUD Pivotal Trial · NA · completed
- NCT05162833 — Evaluation of the TheraNova Neuromodulation System to Provide Durable Relief of Overactive Bladder Symptoms · NA · completed
- NCT04758247 — Evaluation of the TheraNova Neuromodulation System for the Treatment of Overactive Bladder Symptoms · NA · completed
- NCT04901481 — Empower Neuromodulation System - Pilot Study for Anxiety Treatment · NA · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04244227 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Theranova, L.L.C.
- Last refreshed: 21 February 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04244227.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing