| NCT ID | NCT05766761 |
| Status | Recruiting |
| Phase | — |
| Sponsor | New York University |
| Condition | Alcohol Drinking |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2024-04-15 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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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 600 participants in total. It began in 2024-04-15 with a primary completion date of 2026-09.
⚠ 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 goal of this clinical trial is to compare an active intervention versus a standard of care control in reducing alcohol use among pregnant women. The main questions it aims to answer are whether a motivational intervention can: 1. increase the proportion of women detected with a laboratory-confirmed negative phosphatidylethanol (PEth) test during pregnancy, and 2. reduce the proportion of adverse birth outcomes among infants. Participants will be offered (1) a self-paced computer-delivered alcohol reduction intervention to enhance knowledge, norms, and motivation for alcohol reduction and (2) a nurse-delivered component to reinforce the computer-delivered content and address women's questions. Both components are theory-driven, based on Motivational Enhancement Theory (MET), and use motivational strategies to promote alcohol reduction.
Eligibility Criteria
Inclusion Criteria: * 18 years and above * Gestational age is 28 weeks or less * Recent alcohol use as assessed by self-report of alcohol use in the previous 30 days Exclusion Criteria: * Under 18 years of age * Not pregnant or gestational age over 28 weeks * No recent alcohol use as assessed by self-report
Contact & Investigator
Ralph DiClemente, PhD
PRINCIPAL INVESTIGATOR
New York University
Frequently Asked Questions
Who can join the NCT05766761 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Alcohol Drinking. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05766761 currently recruiting?
Yes, NCT05766761 is actively recruiting participants. Contact the research team at cphs@uth.tmc.edu for enrollment information.
Where is the NCT05766761 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT05766761 clinical trial?
NCT05766761 is sponsored by New York University. The principal investigator is Ralph DiClemente, PhD at New York University. The trial plans to enroll 600 participants.