Last reviewed · How we verify
NCT06005298: SEAL
Alcohol Misuse, Gut Microbial Dysbiosis and PrEP Care Continuum: Application and Efficacy of SBIRT Intervention
NA trial testing Screening, Brief Intervention, Referral to Treatment (SBIRT) in Alcohol Use Disorder in 120 participants. Currently enrolling.
24 October 2027
Quick facts
| Lead sponsor | Shirish S Barve |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 120 |
| Start date | 1 August 2023 |
| Primary completion | 24 October 2027 |
| Estimated completion | 24 October 2027 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Screening, Brief Intervention, Referral to Treatment (SBIRT)
Conditions studied
- Alcohol Use Disorder — all drugs for Alcohol Use Disorder →
- Risk Behavior, Health — all drugs for Risk Behavior, Health →
- Dysbiosis — all drugs for Dysbiosis →
- HIV Infections — all drugs for HIV Infections →
Sponsor
Shirish S Barve
Who can join
Adults 18 to 85, any sex, with Alcohol Use Disorder or Risk Behavior, Health. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This randomized control trial study among Pre-exposure prophylactic users (PrEP) aims to learn and determine the efficacy of Screening, brief intervention, and referral to treatment (SBRIT) in reducing the risk of alcohol use. The main questions it aims to answer are: 1. How alcohol use impacts the PrEP continuum and to understand how early intervention and treatment approach affects alcohol use and PrEP adherence. 2. Investigate the effectiveness of the SBIRT intervention in preventing hazardous alcohol use and its impact on gut dysbiosis in PrEP users. 3. To determine alterations in the gut microbiome (dysbiosis), intestinal homeostasis, systemic inflammation, and markers of liver disease associated with hazardous alcohol use among PrEP users.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06005298
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Alcohol Use Disorder
Currently open trials in the same condition.
- NCT06860607 — Environment and Alcohol: A Pilot Study · Phase 1 · recruiting
- NCT07325266 — Human Laboratory Study of Apremilast for Alcohol Use Disorder · Phase 2 · recruiting
- NCT07046819 — Tirzepatide in MetALD · Phase 2 · recruiting
- NCT07279558 — Cannabidiol and Alcohol Use Disorder Phenotypes · Phase 2 · recruiting
- NCT07056894 — Effects of Action-Based Cognitive Remediation on Substance Misuse in Early Phase Psychosis · NA · recruiting
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 NCT06005298 (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 Shirish S Barve
- Last refreshed: 22 July 2024
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/NCT06005298.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing