50 Participants NeededMy employer runs this trial

NTX-2001 for Alcoholism

NT
Overseen ByNewleos Therapeutics Clinical Trial Team
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Newleos Therapeutics, Inc.

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called NTX-2001, a potential drug for individuals with Alcohol Use Disorder (AUD). Researchers aim to determine if NTX-2001 can reduce alcohol consumption and assess its safety. Participants will take either NTX-2001 or a placebo (a pill with no active drug) daily for two weeks, with several clinic visits over ten weeks. This trial may suit adults with AUD who are not currently seeking treatment and have not received treatment in the last six months. Participants should also be comfortable with spirits (hard liquor), as those who dislike them are not eligible. As a Phase 1 trial, this research focuses on understanding how NTX-2001 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are regularly taking psychotropic medications, except for a stable dose of an antidepressant for at least 2 months before the trial.

Is there any evidence suggesting that NTX-2001 is likely to be safe for humans?

An earlier study found that NTX-2001 had side effects that most adults could handle, meaning most did not experience severe or unpleasant reactions. The research remains in the early stages, primarily focusing on safety. So far, results suggest that patients generally tolerate NTX-2001 well. However, as this is an early study, further research is necessary to confirm these findings.12345

Why do researchers think this study treatment might be promising for alcoholism?

Researchers are excited about NTX-2001 for alcoholism because it introduces a novel approach compared to traditional treatments like naltrexone, acamprosate, and disulfiram. NTX-2001 might offer a unique mechanism of action, potentially targeting specific brain pathways involved in alcohol addiction more precisely. This specificity could lead to fewer side effects and improved outcomes for patients. Additionally, NTX-2001 could provide a new option for those who don't respond well to existing treatments, offering hope for more personalized and effective care in managing alcoholism.

What evidence suggests that NTX-2001 might be an effective treatment for Alcohol Use Disorder?

Research suggests that NTX-2001, a medication tested in this trial, might help reduce alcohol use in adults with Alcohol Use Disorder (AUD). NTX-2001 may activate certain brain receptors, potentially lowering the urge to drink and the amount consumed. Early results from similar studies indicate that targeting these receptors can positively affect drinking habits. Although specific data on NTX-2001 remains limited, its mechanism appears promising for reducing alcohol use. Experts agree that this approach is worth exploring due to its potential benefits for those dealing with AUD. Participants in this trial will receive either NTX-2001 or a placebo to evaluate its effectiveness.15678

Are You a Good Fit for This Trial?

This trial is for English-speaking men and women aged 21-60 who have Alcohol Use Disorder, a BMI between 18 and 35, are not currently in alcohol treatment or using most other substances, and do not have serious mental health or major liver/kidney problems. Women must use effective birth control if they could become pregnant.

Inclusion Criteria

Has provided written informed consent for the study and is willing to comply with all requirements of the protocol
My BMI is between 18 and 35.
Meets DSM-5 criteria for Alcohol Use Disorder (AUD) confirmed by Mini-International Neuropsychiatric Interview (MINI)
See 3 more

Exclusion Criteria

Current diagnosis of substance use disorder, except for tobacco use disorder or mild cannabis use disorder as defined by the DSM-5
I do not like drinking hard liquor.
Currently seeking alcohol treatment or have been in alcohol treatment within the past 6 months
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take NTX-2001 or matching placebo every day for 2 weeks

2 weeks
4 visits (in-person) over 10 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • NTX-2001

Trial Overview

The study tests NTX-2001, a new medication targeting the TAAR1 receptor, to see if it reduces drinking in people with Alcohol Use Disorder. Participants take either NTX-2001 or a placebo daily for two weeks; visits occur over ten weeks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: NTX-2001Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Newleos Therapeutics, Inc.

Lead Sponsor

Yale University

Collaborator

Trials
1,963
Recruited
3,046,000+

Citations

NCT07520292 | Study of NTX-2001 on Alcohol ...

The primary goal of this Phase 1b clinical trial is to evaluate the effects of a novel TAAR1 receptor partial agonist (NTX-2001) in adults with Alcohol Use ...

Prazosin + naltrexone decreases alcohol drinking more ... - PMC

Both daily and “as-needed” treatment with PRZ+NTX are highly effective in suppressing daily, intermittent and post-deprivation alcohol drinking in male P rats ...

Newleos Announces Dosing of First Participant in Phase ...

Demonstrating early signs of efficacy in this NTX-2001 study would provide clinical support that the TAAR1 mechanism may reduce alcohol use in ...

Naltrexone and Cue Exposure With Coping ...

Drinking outcomes were assessed at 3, 6, and 12 months after discharge from the partial hospital. Process measures included urge, self-efficacy ...

Newleos Announces Dosing of First Participant in Phase ...

Demonstrating early signs of efficacy in this NTX-2001 study would provide clinical support that the TAAR1 mechanism may reduce alcohol use in ...

Newleos Announces Dosing of First Participant in Phase ...

Newleos Announces Dosing of First Participant in Phase 1b Study of NTX-2001 for Alcohol Use Disorder. Press Release. By: Ref: Business Wire.

Effect of Extended-Release Naltrexone (XR-NTX) on Quality of ...

Extended-release naltrexone (XR-NTX) is a once-a-month injectable formulation for the treatment of alcohol dependence previously shown to reduce drinking and ...

NTX-2001 for Alcoholism

This Phase 1 medical study run by Newleos Therapeutics, Inc. is evaluating whether NTX-2001 will have tolerable side effects & efficacy for ...