Last reviewed · How we verify
NCT03235531: PAVE
Assessment of Valproate on Ethanol Withdrawal
Phase 4 trial testing Valproate in Alcohol Dependence in 210 participants. Status unknown.
11 July 2019
Quick facts
| Lead sponsor | CAMC Health System |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 210 |
| Start date | 11 July 2017 |
| Primary completion | 11 July 2019 |
| Estimated completion | 1 January 2020 |
| Sites | 2 locations across United States |
Drugs / interventions tested
Conditions studied
- Alcohol Dependence — all drugs for Alcohol Dependence →
- Alcohol Withdrawal Syndrome — all drugs for Alcohol Withdrawal Syndrome →
- Trauma — all drugs for Trauma →
- Heavy Drinking — all drugs for Heavy Drinking →
Sponsor
CAMC Health System — full company profile →
Who can join
18 and older, any sex, with Alcohol Dependence or Alcohol Withdrawal Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Alcohol use disorder, or heavy drinking, is commonly seen in patients who present to trauma centers. These patients are at risk for Alcohol Withdrawal Syndrome (AWS), which is collection of symptoms that can range from anxiety and restlessness to seizures, delirium and even death. The Clinical Institute Withdrawal Assessment (CIWA) tool is routinely used to assess alcohol withdrawal symptoms. Benzodiazepines (BZD) are commonly administered to trauma patients who exhibit symptoms of AWS based on the CIWA scoring system. Although these medications have proven efficacy, they can also have negative side effects which may affect recovery. Valprate (VPA) is a medication which may have efficacy in management of AWS symptoms, thus ameliorating or preventing the need for BZD administration. This trial will study the effectiveness of VPA in the prevention of AWS symptoms by comparing the amount of BZD use in trauma patients who receive BZD treatment as indicated by CIWA scores with patients who receive prophylactic VPA therapy in addition to BZD as indicated by CIWA scores.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
GABAergic signaling in alcohol use disorder and withdrawal: pathological involvement and therapeutic potential.
Dharavath RN, Pina-Leblanc C, Tang VM, Sloan ME, et al · · 2023 · cited 31× · PMID 37929054 · DOI 10.3389/fncir.2023.1218737
Verify or expand the search:
- PubMed search for NCT03235531
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other CAMC Health System trials
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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 NCT03235531 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by CAMC Health System
- Last refreshed: 1 August 2017
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/NCT03235531.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing