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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

Testing TMP-301 safety for adults with alcohol use disorder.

Recruiting
18-65 years
All
Phase 2

This study is testing if a new drug, TMP-301, is safe and helps reduce alcohol consumption in adults with Alcohol Use Disorder (AUD). AUD is a condition where a person struggles to control their alcohol intake. TMP-301 has been tested before and found safe in healthy people. This study will compare TMP-301 to a placebo, which is a harmless pill used to see if the real drug works better. Participants must be 18-65 years old and have had at least 8 days of heavy drinking in the last month. The study lasts up to 19 weeks, with 14 weeks of treatment and weekly visits to the study center.

  • Expect weekly visits for up to 19 weeks.
  • You can't participate if you have certain health conditions or take specific medications.
  • Participants must agree to use effective birth control during the study.

**Note**: Heavy drinking is defined as 4 or more drinks for women and 5 or more drinks for men in one day. If interested, ensure you meet the study's health and lifestyle requirements before joining.

Study details
    Alcohol Use Disorder (AUD)

NCT06648655

Tempero Bio, Inc.

3 May 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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