100 Participants Needed

TMP-301 for Alcoholism

Recruiting at 13 trial locations
CG
EK
Overseen ByElla Kleynerman
Prior Safety DataThis treatment has passed at least one previous human trial

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

I drink 4 or more drinks a day if female, 5 or more if male.
I have signed the consent form and can follow the study rules. I passed a breathalyzer test.
I have had 8 or more heavy drinking days in the last month.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TMP-301 or placebo daily for 14 weeks to assess safety, tolerability, and efficacy in reducing alcohol consumption

14 weeks
14 visits (weekly, in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

  • TMP-301
Trial Overview The trial is testing TMP-301, which may help reduce alcohol consumption, against a placebo (a substance with no therapeutic effect). Participants will receive either TMP-301 or the placebo to assess its safety and effectiveness in treating alcohol use disorder.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TMP-301Experimental Treatment1 Intervention
Daily (QD) x 14 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Daily (QD) x 14 weeks.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Tempero Bio, Inc.

Lead Sponsor

Trials
3
Recruited
150+
Unbiased ResultsWe believe in providing patients with all the options.
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