Last reviewed · How we verify

NCT06591026

Helpline Pilot Factorial Trial

Not yet recruiting Phase 1 Last updated 15 January 2025
What this trial tests

Phase 1 trial testing Standard Helpline (SH) in Heavy Drinking in 120 participants. Not yet recruiting.

Timeline
1 December 2025
Primary endpoint
31 July 2027
31 July 2027

Quick facts

Lead sponsorThe National Center on Addiction and Substance Abuse at Columbia University
PhasePhase 1
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationrandomized
Designfactorial
Maskingsingle
Primary purposetreatment
Enrollment120
Start date1 December 2025
Primary completion31 July 2027
Estimated completion31 July 2027

Drugs / interventions tested

Conditions studied

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:

Other recruiting trials for Heavy Drinking

Currently open trials in the same condition.

Other The National Center on Addiction and Substance Abuse at Columbia University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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