Last reviewed · How we verify
NCT06591026
Helpline Pilot Factorial Trial
Phase 1 trial testing Standard Helpline (SH) in Heavy Drinking in 120 participants. Not yet recruiting.
31 July 2027
Quick facts
| Lead sponsor | The National Center on Addiction and Substance Abuse at Columbia University |
|---|---|
| Phase | Phase 1 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | factorial |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 1 December 2025 |
| Primary completion | 31 July 2027 |
| Estimated completion | 31 July 2027 |
Drugs / interventions tested
- Standard Helpline (SH)
- Motivational Interviewing (MI)
- Coping Skills Training (CST)
- Automated Text Messaging (ATM)
Conditions studied
- Heavy Drinking — all drugs for Heavy Drinking →
Sponsor
The National Center on Addiction and Substance Abuse at Columbia University
Who can join
Adults 18 to 45, female only, with Heavy Drinking. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The pilot factorial trial will (1) evaluate feasibility, acceptability, and fidelity of the intervention components (Aim 2.1), and (2) collect proof-of-concept data on the impact of the components on the proximal (motivation, self-efficacy, and self-regulation) and distal (quantity and frequency of HED) outcomes (Aim 2.2). Participants will include 120 postpartum mothers recruited from social media. The investigators will conduct a pilot 2X2X2 balanced full factorial trial, with 4 factors (1 constant, 3 randomized to 2 levels each) and 8 study conditions. The 4 factors will include: (1) Standard Helpline (constant); (2) Motivational Interviewing (yes vs. no); (3) Coping skills training (yes vs. no); (4) Automated messaging (yes vs. no). Participants will be randomly assigned to one of 8 study conditions, which will determine which combination of intervention components participants receive.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06591026
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Heavy Drinking
Currently open trials in the same condition.
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Other The National Center on Addiction and Substance Abuse at Columbia University trials
Trials by the same sponsor.
- NCT06624332 — Home Visitation Enhancing Linkages Project in Kansas · NA · not yet recruiting
- NCT06413979 — Family Support Protocol for Adolescent Internalizing Disorders · NA · recruiting
- NCT04719390 — BabySTEPs: Supportive Texts to Empower Parents · NA · completed
- NCT03750487 — Home Visitation Enhancing Linkages Project · NA · completed
- NCT03722654 — Measurement Training and Feedback System: Family Therapy and CBT · 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 NCT06591026 (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 The National Center on Addiction and Substance Abuse at Columbia University
- Last refreshed: 15 January 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/NCT06591026.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing