Last reviewed · How we verify
NCT05591703: RESTOREb
Clinical Outcomes Following Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention: A Long-term Follow-up Study
trial testing Clinical Outcomes and Questionnaires in Opioid Use Disorder in 32 participants. Completed in 31 January 2025.
31 January 2025
Quick facts
| Lead sponsor | Spark Biomedical, Inc. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 32 |
| Start date | 21 November 2022 |
| Primary completion | 31 January 2025 |
| Estimated completion | 31 January 2025 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- Clinical Outcomes and Questionnaires
Conditions studied
- Opioid Use Disorder — all drugs for Opioid Use Disorder →
- Relapse — all drugs for Relapse →
Sponsor
Spark Biomedical, Inc.
Who can join
Adults 18 to 65, any sex, with Opioid Use Disorder or Relapse. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a prospective, observational, longitudinal study to assess clinical outcomes in the 12-months following participants' exit from protocol SBM-OWP-03, Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder (RESTORE; ClinicalTrials.gov Identifier: NCT05053503). Clinical outcome scores will be collected at study exit from protocol SBM-OWP-03, 1 month, 3 months, 6 months, 9 months, and 12 months after study exit from protocol SBM-OWP-03.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05591703
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT06943859 — Ketamine for Opioid Use Disorder · Phase 2 · recruiting
- NCT06651177 — Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder · Phase 2 · recruiting
Other Spark Biomedical, Inc. trials
Trials by the same sponsor.
- NCT07326722 — Delivering tAN to Reduce HMB: The LUNA Study · NA · recruiting
- NCT07281261 — tAN for Substance Use Disorder · NA · recruiting
- NCT07109349 — tAN for First Responders · NA · recruiting
- NCT06487533 — Sensing Physiological Symptoms of Opioid Withdrawal and Cravings in Patients With Opioid Use Disorder · recruiting
- NCT06814028 — Transcutaneous Auricular Neurostimulation as a Treatment for Women With Heavy Menstrual Bleeding: A Dose-finding Trial · NA · completed
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 NCT05591703 (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 Spark Biomedical, Inc.
- Last refreshed: 9 April 2025
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/NCT05591703.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing