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ACTIVE_NOT_RECRUITINGPHASE2

A Study to Investigate the Safety and Efficacy of TMP-301 Compared to Placebo in Adult Patients With Alcohol Use Disorder

A Phase 2, Randomized, Investigator and Participant bLInded, placeBo-controllEd, paRallel-group Study to Investigate the sAfety, Tolerability, and Preliminary Efficacy of TMP-301 TrEatment in Adult Patients With Alcohol Use Disorder (AUD)

NCT06648655•Tempero Bio, Inc.

View on ClinicalTrials.gov

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.

Detailed Description

The purpose of this study is to assess the safety, tolerability and effect on alcohol use (number of heavy drinking days) of TMP-301 compared to placebo in patients with alcohol use disorder. This is a placebo-controlled, parallel-group, multicenter clinical study in moderate to severe alcohol use disorder with ≥8 heavy drinking days over the prior 4 weeks at screening. Study participants and investigators will be blinded to study intervention. The study duration will be up to 19 weeks, with a treatment duration of up to 14 weeks. The visit frequency will be weekly.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Provision of signed and dated Informed Consent Form (ICF) with a stated willingness to comply with all study procedures and availability for the duration of the study. A breathalyzer test must be \<0.05% at the time of ICF signing. Participants who have a blood alcohol content between 0.02 and 0.04% inclusive at Screening will be assessed for competency to consent using the UBACC scale. Participants must have a passing score of ≥ 15 during the Screening period to consent and be eligible for randomization.
•2. Adult female or male, 18 to 65 years of age inclusive, at the time of screening.
•3. Alcohol use disorder, moderate or severe by DSM-5 diagnostic criteria (i.e., ≥4 out of 11 symptoms present using the SCID-5-CT diagnostic interview) at screening for the previous 12 months.
•4. At least 8 heavy drinking days over the previous 4 weeks (by Timeline Follow Back) at screening.
•* Heavy Drinking Days (HDD): ≥4 drinks/day for females, ≥5 drinks/ day for males.
•* A standard drink is defined as 12 ounces (350 ml) of 5% beer, 5 ounces (150 ml) of 12% wine, or 1.5 ounces (44 ml) of 80-proof (40%) distilled spirits.
•5. Seeking treatment for AUD, with a desire to reduce or cease alcohol use at screening.
•6. Breathalyzer \<0.05% at baseline..
•7. BMI of ≥18.0 to ≤40.0 kg/m2 at screening.
•8. No clinically significant findings (in the investigator's opinion) on physical exam, ECG, vital signs, or clinical laboratory tests at screening. The following criteria must be met:
+15 more criteria

Exclusion Criteria

•1. History of hypersensitivity to TMP-301 or other mGluR5 antagonists.
•2. Evidence of suicidal risk as assessed by the Columbia-Suicide Severity Rating Scale at screening or baseline as follows:
•* Suicidal Ideation Section: "Yes" on item 4 or 5 if within 6 months of screening or between screening and baseline.
•* Suicidal Behavior Section: "Yes" on any item (except non-suicidal self-injurious behavior) if within 2 years of screening or between screening and baseline.
•3. Significant risk of acute alcohol withdrawal syndrome (either of the following):
•* Any history of Delirium Tremens or seizures from alcohol withdrawal.
•* Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) score \>7 at screening or baseline.
•4. Any history of seizures, except febrile seizures as a child.
•5. Other (non-alcohol) substance use disorders (by DSM-5) as follows:
•* Any cocaine or stimulant use disorder
+39 more criteria

Locations (14)

Headlands Research

Scottsdale, Arizona, United States

Yale School of Medicine

New Haven, Connecticut, United States

Research Centers of America, LLC

Hollywood, Florida, United States

CNS Healthcare- Jacksonville South

Jacksonville, Florida, United States

Segal Trials - West Broward Outpatient Site

Lauderhill, Florida, United States

CNS Healthcare

Orlando, Florida, United States

CenExcel iResearch

Decatur, Georgia, United States

CenExcel iResearch

Savannah, Georgia, United States

DelRicht Research - Murphy Clinic

Mandeville, Louisiana, United States

IMA Clinical Research

Albuquerque, New Mexico, United States

Key Dates

Start Date

November 14, 2024

Primary Completion Date

November 15, 2025

Completion Date

November 15, 2025

Last Updated

July 10, 2025

Enrollment

110

ACTUAL participants

Conditions

Alcohol Use Disorder (AUD)

Interventions

TMP-301

DRUG

Placebo

DRUG

Web-based Alcohol- or Cocaine-specific Inhibition Training in Adolescents and Young Adults With Substance Use Disorder

NCT07071779

Alcohol Use Disorder (AUD)Cocaine Use Disorder (CUD)+1 more

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RECRUITINGNA

Combining a Smartphone App With Medications to Manage Heavy Drinking

NCT06303778

Alcohol Use Disorder (AUD)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Investigate the Safety and Efficacy of TMP-301 Compared to Placebo in Adult Patients With Alcohol Use Disorder

Inclusion Criteria

Exclusion Criteria

Web-based Alcohol- or Cocaine-specific Inhibition Training in Adolescents and Young Adults With Substance Use Disorder

Combining a Smartphone App With Medications to Manage Heavy Drinking

iTBS for Alcohol Use Disorder

Attentional Control Training for Treating Alcohol Use Disorder

Assessing Habitual, Goal-Directed, and Pavlovian Influences in Alcohol Use Disorder

Cue Effects in Human Addiction: Pavlovian to Instrumental Transfer