Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2026-01-01 @ 8:19 AM
Study NCT ID:
NCT06324435
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-17
First Post:
2024-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Apremilast for Alcohol Use Disorder Treatment in Women and Men
Sponsor:
Yale University
Organization:
Study Overview
Official Title:
Apremilast for Alcohol Use Disorder Treatment in Women and Men
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
For this protocol, the investigators plan to collect pilot data to evaluate apremilast (60mg/day) in adults with Alcohol Use Disorders (AUD).
Detailed Description:
This study is a Phase 1 open-label design to evaluate apremilast (60mg/day) in adults meeting criteria for DSM-5 alcohol use disorders (n=10).
Eligibility screening consists of an intake session and a physical exam. Subjects meeting eligibility criteria will be assigned to apremilast (60mg/day). Titration to steady state medication levels will occur over 6 days (Day 1-6). Subjects will then complete two laboratory sessions and a cue-reactivity session (Days 7-21). During each laboratory session, personalized imagery (within- subject factor, either stress or neutral/relaxing, order counterbalanced) will precede a 2-hour alcohol self-administration period.
No taper medication is needed. Following the medication discontinuation (Day 22), subjects will be contacted to assess any side effect from discontinuing medication (Day 36).
Adverse events are evaluated at each study appointment and will be tabulated.
Eligibility screening consists of an intake session and a physical exam. Subjects meeting eligibility criteria will be assigned to apremilast (60mg/day). Titration to steady state medication levels will occur over 6 days (Day 1-6). Subjects will then complete two laboratory sessions and a cue-reactivity session (Days 7-21). During each laboratory session, personalized imagery (within- subject factor, either stress or neutral/relaxing, order counterbalanced) will precede a 2-hour alcohol self-administration period.
No taper medication is needed. Following the medication discontinuation (Day 22), subjects will be contacted to assess any side effect from discontinuing medication (Day 36).
Adverse events are evaluated at each study appointment and will be tabulated.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1U54AA027989-01 | NIH | None | https://reporter.nih.gov/quic… | View |