TMP-301 for Alcoholism
Trial Summary
Will I have to stop taking my current medications?
The trial requires that participants do not use certain medications, including those for substance use disorders and some psychoactive medications. If you are on any of these, you may need to stop taking them before joining the trial. Please discuss your specific medications with the study team to see if they are allowed.
What is the purpose of this trial?
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.
Eligibility Criteria
Adults aged 18-65 with alcohol use disorder who want to reduce or stop drinking can join this trial. They must have had at least 8 heavy drinking days in the last month and be willing to follow study rules. People with blood pressure outside of specified ranges or a BMI not between 18.0 and 40.0 kg/m2 cannot participate.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive TMP-301 or placebo daily for 14 weeks to assess safety, tolerability, and efficacy in reducing alcohol consumption
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- TMP-301
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tempero Bio, Inc.
Lead Sponsor