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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Alcohol Use Disorder (AUD)

In brief

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.

Key facts

Study ID

NCT06648655

Run by

Tempero Bio, Inc.

People needed

110

Starts

2024-11-14

Expected to finish

2025-11-14

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Adult female or male, 18 to 65 years of age inclusive, at the time of screening.
• 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.
• 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.
• Seeking treatment for AUD, with a desire to reduce or cease alcohol use at screening.
• Breathalyzer <0.05% at baseline..
• BMI of ≥18.0 to ≤40.0 kg/m2 at screening.
• 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:
• Systolic Blood Pressure (SBP) 90-140 mmHg, and Diastolic Blood Pressure (DBP) 50-90 mmHg, inclusive (average of three readings) at screening and baseline.
• Alanine transaminase (ALT) and Aspartate transferase (AST) < 3x upper limit of normal, and total bilirubin < upper limit of normal (isolated elevated total bilirubin is allowed if Gilbert's syndrome is the suspected etiology)..
• Estimated Glomerular Filtration Rate (eGFR) ≥ 60 mL/min/1.73 m2
• Negative urine drug screen for cocaine or stimulants at screening and baseline
• Able to communicate well and understand written instructions.
• Agree to practice highly effective birth control starting at screening and continuing for 30 days (females) or 90 days (males) after study treatment ends.
• For females any of the following (no donation of eggs/ova is allowed):
• Abstinence from heterosexual intercourse.
• Postmenopausal: absence of menses ≥ 12 months (without an alternative medical condition) and Follicle-Stimulating Hormone (FSH) ≥ 40 mIU/mL at screening.
• Surgically sterile: bilateral oophorectomy, salpingectomy, tubal ligation, or hysterectomy ≥180 days prior to screening.
• Contraceptive implant or intrauterine device.
• For males any of the following (no donation of sperm is allowed):
• Abstinence from heterosexual intercourse.
• Male condom with spermicide or male condom with vaginal spermicide (gel, foam, or suppository).
• Surgically sterile: post vasectomy or bilateral orchiectomy

You may not qualify if…

• History of hypersensitivity to TMP-301 or other mGluR5 antagonists.
• 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.
• 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.
• Any history of seizures, except febrile seizures as a child.
• Other (non-alcohol) substance use disorders (by DSM-5) as follows:
• Any cocaine or stimulant use disorder
• Moderate or severe use disorder of all other substances (mild allowed).
• Use of the following within the last 90 days or ≥ 5 times the half-life prior to randomization:
• Pharmacotherapy for any substance use disorder (e.g.: disulfiram, acamprosate, modafinil, topiramate, or baclofen).
• Use of prescribed methylphenidate or other stimulant.
• Use of any Glucagon-like peptide 1 (GLP-1) agonist for any indication.
• Past or current history of any mental, behavioral, or neurodevelopmental disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) or significant risk of developing a psychosis (assessed by PRIME screen) or a personal history of psychotic symptoms (hallucinations or delusions) with or without a formal psychiatric diagnosis.
• Individuals with AUD or mild other substance use disorder (except for cocaine or stimulants) may participate.
• Individuals who meet criteria for a current major depressive episode are excluded.
• Requires treatment with any psychoactive medications, including any anti-seizure medications (except medications used for short-term treatment of insomnia).
• Antidepressant medications are allowed if the patients have been on an adequate and stable dose for at least 3 months prior to study treatment dosing with the exception of CYP1A2 substrates or CYP3A4 inhibitors as detailed in Exclusion 19.
• Having had initiation of, or change in intensity of, psychotherapy or other non-drug therapies within 6 weeks prior to enrollment or unwillingness to maintain current psychotherapeutic and non-drug therapy levels from screening through the or at any time during the acute treatment phase of the study.
• Use of other investigational drugs or devices at the time of screening, or within 5 half-lives of randomization, or within 30 days, whichever is longer or has been part of any clinical study within 30 days of randomization.
• Pregnant or nursing (lactating) females.
• Recent history or active clinically significant manifestations of metabolic, hepatic, renal (including porphyria), hematological, pulmonary, cardiovascular, gastrointestinal, musculoskeletal, dermatological, urogenital, neurological, ophthalmic, or ears, nose, and throat (ENT) disorders, or any other acute or chronic condition or medication use that, in the Investigator's opinion, would limit the subject's ability to complete or participate in this clinical study.
• Concomitant use of agents known to prolong the QT interval unless these can be permanently discontinued for the duration of study.

Where it is running

• 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
• Neurobehavioral Research, Inc. — Cedarhurst, New York, United States
• Medical University of South Carolina, Institute of Psychiatry — Charleston, South Carolina, United States
• Baylor College of Medicine — Houston, Texas, United States
• University of Virginia: Center for Leading Edge Addiction Research — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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