Last reviewed · How we verify
NCT05630118
Online Insomnia Intervention to Reduce Alcohol Use
NA trial testing SHUTi Intervention in Alcohol Use Disorder in 113 participants. Completed in 7 July 2025.
7 July 2025
Quick facts
| Lead sponsor | Jessica Weafer |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 113 |
| Start date | 24 January 2023 |
| Primary completion | 7 July 2025 |
| Estimated completion | 7 July 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- SHUTi Intervention
- Web-Based Insomnia Education Program
Conditions studied
- Alcohol Use Disorder — all drugs for Alcohol Use Disorder →
- Heavy Drinking — all drugs for Heavy Drinking →
Sponsor
Jessica Weafer
Who can join
Adults 18 to 50, any sex, with Alcohol Use Disorder or Heavy Drinking. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Alcohol use disorder (AUD) inflicts enormous physical, emotional, and financial burdens on the individual and society at large. Insomnia is highly prevalent among individuals with AUD, and disrupted sleep contributes substantially to alcohol-related problems. While research suggests that treating insomnia may effectively reduce AUD, the degree to which treating insomnia in heavy drinkers reduces alcohol consumption and prevents the onset of severe AUD is not known. This study will be the first to evaluate an Internet-based version of cognitive behavioral therapy for insomnia (CBT-I) in community-dwelling, heavy drinking adults with insomnia. Sleep Healthy Using the Internet (SHUTi), the most widely-used and well-validated version of Internet-based CBT-I will be used. The primary aim is to reduce alcohol consumption and insomnia severity in this population.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Effects of digital cognitive-behavioral therapy for insomnia in heavy drinkers with insomnia: A replication and extension study.
Verlinden JJ, Moloney ME, Vsevolozhskaya OA, Ritterband LM, et al · · 2026 · PMID 41785115 · DOI 10.1037/pha0000834
Verify or expand the search:
- PubMed search for NCT05630118
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of SHUTi Intervention
Trials testing the same drug.
- NCT04564807 — Testing an Online Insomnia Intervention · NA · completed
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
Other Jessica Weafer trials
Trials by the same sponsor.
- NCT05929677 — Impulsivity Domains and Subjective Response · EARLY_PHASE1 · recruiting
- NCT04929288 — Neural and Hormonal Influences on Sex Differences in Risk for AUD · NA · recruiting
- NCT04564807 — Testing an Online Insomnia Intervention · 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 NCT05630118 (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 Jessica Weafer
- Last refreshed: 5 February 2026
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/NCT05630118.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing