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NCT06648655 · ClinicalTrials.gov registry record · Phase 2
A Study to Investigate the Safety and Efficacy of TMP-301 Compared to Placebo in Adult Patients With Alcohol Use Disorder
A Phase 2 study of Alcohol Use Disorder (AUD), sponsored by Tempero Bio.
- Active
- Registry status
- Phase 2
- Development phase
- 110
- Enrollment target
- 14
- Study locations
NCT06648655: Active Phase 2 study of Alcohol Use Disorder (AUD), sponsored by Tempero Bio.
NCT06648655 is a Phase 2 study of Alcohol Use Disorder (AUD) that is active but no longer recruiting, run by Tempero Bio. The registered enrollment target is 110 participants, below the 1,820-participant average among 30 other Alcohol Use Disorder (AUD) trials with a reported enrollment target (94% lower). The trial reports 14 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06648655, a Phase 2 study of Alcohol Use Disorder (AUD), is active but no longer recruiting, sponsored by Tempero Bio.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 110 participants
- Enrollment target
- 14
- Study locations
Study Summary
TMP-301 has been shown in preclinical models to reduce consumption of alcohol and other addictive substances. It has been tested in healthy subjects and has been found to be safe and tolerated at doses predicted to be efficacious in alcohol use disorder. This study is being conducted to evaluate the safety, tolerability and efficacy of TMP-301 in patients with alcohol use disorder.
Primary Outcome
To evaluate the safety and tolerability of TMP-301 in patients with alcohol use disorder by the incidence and severity of Adverse Events
Conditions Studied
Interventions
- DRUG Placebo
- DRUG TMP-301
Study Locations (14)
Florida
- Research Centers of America, LLC - Hollywood
- CNS Healthcare- Jacksonville South - Jacksonville
- Segal Trials - West Broward Outpatient Site - Lauderhill
- CNS Healthcare - Orlando
Georgia
- CenExcel iResearch - Decatur
- CenExcel iResearch - Savannah
Arizona
- Headlands Research - Scottsdale
Connecticut
- Yale School of Medicine - New Haven
Louisiana
- DelRicht Research - Murphy Clinic - Mandeville
New Mexico
- IMA Clinical Research - Albuquerque
New York
- Neurobehavioral Research, Inc. - Cedarhurst
South Carolina
- Medical University of South Carolina, Institute of Psychiatry - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2024-11-14 |
| Est. Completion | 2025-11-15 |
| Phase | Phase 2 |
What the registry record for NCT06648655 still lists
NCT06648655 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 1,820-participant average among 30 other Alcohol Use Disorder (AUD) trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Alcohol Use Disorder (AUD) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06648655 lists 14 locations in 10 states (Florida, Georgia, Arizona).
Frequently Asked Questions
What is clinical trial NCT06648655 about?
NCT06648655 is a clinical study titled "A Study to Investigate the Safety and Efficacy of TMP-301 Compared to Placebo in Adult Patients With Alcohol Use Disorder". TMP-301 has been shown in preclinical models to reduce consumption of alcohol and other addictive substances. It has been tested in healthy subjects and has been found to be safe and tolerated at doses predicted to be efficacious in alcohol use disorder. This study is being conducted to evaluate the...
What is the current status of trial NCT06648655?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 110 participants. The study started on 2024-11-14. Estimated completion is 2025-11-15.
What conditions does trial NCT06648655 study?
This clinical trial studies the following conditions: Alcohol Use Disorder (AUD).
What interventions are being tested in trial NCT06648655?
The interventions under investigation include: Placebo (DRUG), TMP-301 (DRUG).
Who is sponsoring clinical trial NCT06648655?
This trial is sponsored by Tempero Bio, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06648655 being conducted?
This trial has 14 study locations across Arizona, Connecticut, Florida, Georgia, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alcohol Use Disorder (AUD)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06648655's enrollment target sits among peer trials
110 14th of 30 higher than 17 of 30 other Alcohol Use Disorder (AUD) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcohol Use Disorder (AUD) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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