| NCT ID | NCT06591026 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The National Center on Addiction and Substance Abuse at Columbia University |
| Condition | Heavy Drinking |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2026-06-01 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Resides full-time in the United States * Age 18-45 years * Gave birth to an infant within the prior 4 weeks * Speaks and reads English * Owns a text-enabled cell-phone * Receives a score of 2 or more on the T-ACE alcohol risk screener * Reports ONE of the following: (a) drinking weekly or more often in the prior month; or (b) having 4 or more standard drinks at one time at least monthly in the 12 months prior to becoming pregnant. Exclusion Criteria: * Resides outside of the United States * Age under 18 years or over 45 years * Did not give birth to an infant within the prior 4 weeks * Cannot speak and read English * Does not own a text-enabled cell-phone * Does not receive a score of at least 2 on the T-ACE alcohol risk screener * Does not report either drinking weekly or more often in the past month or having 4 or more standard drinks at least monthly in the 12 months prior to becoming pregnant * Scores greater than 4 on the AUDIT-C, indicating an alcohol use disorder
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06591026 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Heavy Drinking. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06591026 currently recruiting?
Yes, NCT06591026 is actively recruiting participants. Contact the research team at sdauber@toendaddiction.org for enrollment information.
Where is the NCT06591026 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06591026 clinical trial?
NCT06591026 is sponsored by The National Center on Addiction and Substance Abuse at Columbia University. The trial plans to enroll 120 participants.