TMP-301 for Alcoholism
(LIBERATE-A Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called TMP-301, a potential drug, to determine its effectiveness in helping people with alcohol use disorder reduce their alcohol consumption. The trial evaluates the safety and efficacy of TMP-301 for individuals who frequently experience heavy drinking days (4+ drinks per day for women, 5+ for men) and wish to cut down or quit drinking. Participants should have struggled with alcohol use disorder for the past year and be ready to make a change. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.
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.
Is there any evidence suggesting that TMP-301 is likely to be safe for humans?
Research has shown that TMP-301 has been tested on healthy individuals and is safe and well-tolerated at doses that might help with alcohol use disorder. Over 80 healthy participants have taken part in these safety tests, generally handling the treatment well without serious issues. Early research on TMP-301 has also demonstrated its potential to reduce the use of alcohol and other addictive substances. While these results are promising, ongoing studies continue to assess how well individuals with alcohol use disorder can tolerate the treatment.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about TMP-301 for treating alcoholism because it offers a potentially new approach compared to current standard treatments, like naltrexone or acamprosate, which focus on reducing cravings and maintaining abstinence. Unlike these, TMP-301 may work through a novel mechanism, possibly targeting different neural pathways associated with alcohol addiction, offering hope for those who don't respond well to existing medications. This unique approach could provide more effective relief from alcohol dependency symptoms and improve overall treatment outcomes.
What evidence suggests that TMP-301 might be an effective treatment for alcoholism?
Research has shown that TMP-301, which participants in this trial may receive, can help reduce alcohol consumption. Early studies demonstrated that it significantly lowered alcohol intake and helped prevent relapse in test models. When tested on healthy individuals, TMP-301 proved to be safe and well-tolerated. These findings suggest it could be effective for people with alcohol use disorder. The treatment alters how certain brain receptors respond to signals, potentially reducing cravings and drinking.12367
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Daily (QD) x 14 weeks.
Daily (QD) x 14 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tempero Bio, Inc.
Lead Sponsor
Citations
1.
reporter.nih.gov
reporter.nih.gov/search/10EECF0E478CC1DE7598B8961CAA4A01A2FFCEB861BF/project-details/10688133TMP-301, A Negative Allosteric Modulator of type 5 ...
TMP-301 showed preclinical efficacy and significantly reduced cocaine self-administration and relapse as well as voluntary alcohol drinking and positive ...
A study to investigate tmp-301 treatment in adult patients ...
A study to investigate tmp-301 treatment in adult patients with alcohol use disorder | BCM.
A Study to Investigate the Safety and Efficacy of TMP-301 ...
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.
A Study to Investigate the Interaction Between TMP-301 ...
This will be a randomized, double-blind, placebo-controlled, parallel-group study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics ...
Trial | NCT06648655
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 ...
Tempero Bio Secures $70 Million Series B Financing to ...
It has shown promising results in preclinical models of alcohol, cocaine and opiate use disorders. TMP-301 has been evaluated in over 80 healthy ...
Nxera Pharma's Partner Tempero Bio Initiates Phase 2 ...
The Phase 2 study initiated will assess the safety, tolerability and effect on alcohol use of TMP-301 compared to placebo in patients with ...
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