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NCT04933916
Study of EMB-001 as a Potential Smoking Cessation Treatment
Phase 1, PHASE2 trial testing EMB-001 in Tobacco Use Disorder in 16 participants. Terminated before completion.
1 April 2023
Quick facts
| Lead sponsor | Embera NeuroTherapeutics, Inc. |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 16 |
| Start date | 10 June 2021 |
| Primary completion | 1 April 2023 |
| Estimated completion | 1 May 2023 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- EMB-001 — full drug profile →
Conditions studied
- Tobacco Use Disorder — all drugs for Tobacco Use Disorder →
Sponsor
Embera NeuroTherapeutics, Inc. — full company profile →
Who can join
Adults 21 to 65, any sex, with Tobacco Use Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
EMB-001 is a combination of 2 drugs: the cortisol synthesis inhibitor, metyrapone (Metopirone®), and the benzodiazepine receptor agonist, oxazepam (original trade name Serax®; now marketed as oxazepam (generic) only). This is an open-label study in up to 50 adult subjects to help smokers abstain from smoking during a 12-week trial period.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04933916
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of EMB-001
Trials testing the same drug.
- NCT04501874 — A Study to Evaluate EMB 001 in Subjects With Cocaine Use Disorder · Phase 2 · completed
Other recruiting trials for Tobacco Use Disorder
Currently open trials in the same condition.
- NCT07466875 — Auricular Stimulation for Nicotine Withdrawal in Psychiatric Inpatients · NA · recruiting
- NCT06678672 — Contingency Management for Veteran Smokers Undergoing Major Elective Surgery · NA · recruiting
- NCT06006143 — Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 2 · Phase 2 · active not recruiting
- NCT06883162 — Cannabis-Tobacco Co-Use Treatment Study · Phase 3 · recruiting
- NCT06798324 — tDCS Plus Varenicline for Smoking Cessation · Phase 4 · recruiting
Other Embera NeuroTherapeutics, Inc. trials
Trials by the same sponsor.
- NCT04501874 — A Study to Evaluate EMB 001 in Subjects With Cocaine Use Disorder · Phase 2 · completed
- NCT03404817 — Single Dose Crossover Comparative Bioavailability and Food Effect Study of Two EMB-001 Formulations · Phase 1 · 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 NCT04933916 (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 Embera NeuroTherapeutics, Inc.
- Last refreshed: 9 August 2023
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/NCT04933916.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing