Sunobinop for Alcoholism

Recruiting at 6 trial locations

Overseen By Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Imbrium Therapeutics

Disqualifiers: Substance use disorder, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a new treatment, sunobinop, can reduce drinking in people with alcohol use disorder. Participants will receive either sunobinop or a placebo, a harmless pill that resembles the real treatment but has no effect. The study aims to determine if sunobinop is more effective than the placebo in lowering alcohol consumption. The trial seeks individuals with moderate or severe alcohol use disorder who have experienced four or more heavy drinking days each week for the past month. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that sunobinop is likely to be safe for humans?

Studies have shown that sunobinop is generally safe and well-tolerated. The most common side effect is drowsiness or increased fatigue. No reports have indicated serious side effects requiring hospitalization. Researchers are also testing sunobinop for other conditions, such as bladder issues, indicating ongoing interest in its safety and potential benefits. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Sunobinop for treating alcoholism because it offers a new approach compared to traditional treatments like naltrexone, acamprosate, and disulfiram. Sunobinop works by targeting specific neural pathways associated with addiction, potentially leading to more effective craving reduction. This could mean better outcomes and fewer side effects for individuals struggling with alcohol dependence. Unlike existing medications, which often focus on blocking the rewarding effects of alcohol or causing unpleasant reactions when alcohol is consumed, Sunobinop may directly address the underlying neurological factors contributing to addiction.

What evidence suggests that sunobinop might be an effective treatment for alcoholism?

Research has shown that sunobinop, which participants in this trial may receive, may help reduce alcohol consumption. Early studies found that people taking sunobinop reported better sleep, potentially leading to improved health. Although limited data exists on its effect on alcohol use disorder, the drug's ability to enhance sleep might also help reduce alcohol cravings. Initial results are promising, but further research is needed to confirm its effectiveness in reducing alcohol intake. Participants in this trial will receive either sunobinop or a placebo designed to match sunobinop. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with moderate or severe alcohol use disorder who are currently seeking treatment. They must have had at least four heavy drinking days each week in the month before starting the trial.

Inclusion Criteria

I have been diagnosed with a serious alcohol use problem.

I am seeking treatment for alcohol use disorder.

I have had 4 or more heavy drinking days weekly in the last month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either sunobinop or placebo to evaluate its impact on alcohol consumption

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sunobinop

Trial Overview

The study tests Sunobinop's effectiveness against a placebo in reducing alcohol intake among participants with alcohol use disorder to see if it can help manage their condition better.

How Is the Trial Designed?

Group I: Sunobinop Experimental Treatment 1 Intervention

Group II: Placebo to match sunobinop Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Imbrium Therapeutics

Lead Sponsor

Trials

5

Recruited

450+

Purdue Pharma LP

Industry Sponsor

Trials

80

Recruited

15,800+

Dr. Craig Landau

Purdue Pharma LP

Chief Executive Officer since 2017

MD from Albany Medical College

Dr. Marcelo Bigal

Purdue Pharma LP

Chief Medical Officer since 2018

MD from Federal University of Rio de Janeiro

Published Research Related to This Trial

In a systematic review of 8 studies involving 1082 alcohol-dependent patients, sodium oxybate (SMO) was found to be more effective in high-severity patients, showing a significant increase in abstinence rates and percentage of days abstinent compared to mild-severity patients.

Longer treatment durations also enhanced the efficacy of SMO, with each additional month leading to a notable increase in the percentage of days abstinent, particularly in high-severity populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sodium Oxybate for Alcohol Dependence: A Network Meta-Regression Analysis Considering Population Severity at Baseline and Treatment Duration. Guiraud, J., Addolorato, G., Aubin, HJ., et al.[2023]

COR659, a new positive allosteric modulator of the GABAB receptor, effectively reduced alcohol self-administration in rats at non-sedative doses, demonstrating greater potency than the reference GABAB PAM, GS39783.

The reduction in alcohol self-administration appears to be primarily due to its action on the GABAB receptor, while also involving other receptor systems, such as the cannabinoid CB1 receptor, particularly in the context of seeking and consuming highly palatable foods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suppressing effect of COR659 on alcohol, sucrose, and chocolate self-administration in rats: involvement of the GABAB and cannabinoid CB1 receptors. Maccioni, P., Colombo, G., Lorrai, I., et al.[2019]

Saikosaponin A (SSA), derived from the herb Bupleurum falcatum, significantly reduces alcohol self-administration in selectively bred Sardinian alcohol-preferring rats, indicating its potential as a treatment for alcohol use disorders.

The study suggests that the GABAB receptor system plays a crucial role in SSA's ability to suppress alcohol consumption, as evidenced by the partial blockade of SSA's effects when a GABAB receptor antagonist was used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing effect of saikosaponin A, an active ingredient of Bupleurum falcatum, on alcohol self-administration in rats: Possible involvement of the GABAB receptor. Maccioni, P., Lorrai, I., Carai, MAM., et al.[2020]

Baclofen and GS39783 effectively suppressed alcohol self-administration in selectively bred alcohol-preferring rats, with baclofen showing a stronger effect across different rat lines, indicating its potential as a treatment for alcohol use disorders.

The study revealed that the sensitivity to these treatments varies among different rat lines, which may reflect the varying effectiveness of alcohol pharmacotherapies in different types of human alcoholics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the effect of the GABAΒ receptor agonist, baclofen, and the positive allosteric modulator of the GABAB receptor, GS39783, on alcohol self-administration in 3 different lines of alcohol-preferring rats. Maccioni, P., Zaru, A., Loi, B., et al.[2021]

The selective V1b receptor antagonist SSR149415 significantly reduced alcohol intake and preference in mice, indicating its potential as a treatment for alcohol dependency.

Combining SSR149415 with the mu-opioid receptor antagonist naltrexone at lower doses resulted in a greater reduction in alcohol consumption than either drug alone, suggesting a synergistic effect that could lead to effective treatment with fewer side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

V1b Receptor Antagonist SSR149415 and Naltrexone Synergistically Decrease Excessive Alcohol Drinking in Male and Female Mice. Zhou, Y., Rubinstein, M., Low, MJ., et al.[2019]

The novel GABAB-positive allosteric modulator ASP8062 significantly reduced alcohol self-administration in male and female rats, showing promise as a treatment for alcohol use disorder (AUD) without the side effects associated with baclofen.

While both ASP8062 and baclofen decreased alcohol consumption, ASP8062 did not affect locomotor activity, indicating it may have a safer profile compared to baclofen, which had varying effects on activity based on sex.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The GABAB receptor positive allosteric modulator ASP8062 reduces operant alcohol self-administration in male and female Sprague Dawley rats. Haile, CN., Carper, BA., Nolen, TL., et al.[2021]

COR659, a novel positive allosteric modulator of the GABAB receptor, effectively suppressed binge-like drinking in rodents, indicating its potential as a treatment for alcohol misuse.

In experiments with C57BL/6J mice and Sardinian alcohol-preferring rats, non-sedative doses of COR659 significantly reduced alcohol intake during binge-drinking scenarios, suggesting its efficacy without causing sedation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing effect of the novel positive allosteric modulator of the GABAB receptor, COR659, on binge-like alcohol drinking in male mice and rats. Lorrai, I., Shankula, C., Gaytan, JM., et al.[2023]

The FDA has approved three main drugs for treating alcoholism: disulfiram, naltrexone, and acamprosate, which are specifically designed to help individuals with alcohol dependence.

There is ongoing research into other medications, such as nalmafene, topiramate, and ondansetron, which are being used off-label, indicating a potential for new treatment options as our understanding of alcoholism improves.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug adjuncts for treating alcohol dependence. Collins, GB., McAllister, MS., Adury, K.[2019]

In a large randomized controlled trial involving 314 alcohol-dependent patients, sodium oxybate (SMO) significantly increased the cumulative abstinence duration (CAD) by an average of 43.1 days compared to placebo during the 6-month treatment period.

The positive effects of SMO on maintaining abstinence were sustained even after the medication was discontinued, and the treatment was well-tolerated by participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sodium oxybate for the maintenance of abstinence in alcohol-dependent patients: An international, multicenter, randomized, double-blind, placebo-controlled trial. Guiraud, J., Addolorato, G., Antonelli, M., et al.[2022]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06545916?term=AREA%5BConditionSearch%5D(Alcohol%20Use%20Disorder)&rank=4

Study of Sunobinop on Alcohol Consumption in ...

A type of eligibility criteria that indicates whether people who do not have the condition/disease being studied can participate in that clinical study. ... An ...

2.

imbriumthera.com

imbriumthera.com/news/imbrium-therapeutics-submits-investigational-new-drug-application-to-evaluate-sunobinop-for-the-potential-treatment-of-alcohol-use-disorder/

News

Sunobinop studies have suggested improvements in various sleep measurements. Building on these data, Imbrium intends to conduct a two-part, ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S0006295225002345

In vitro pharmacological evaluation of the novel NOP ...

Data from a small study of insomnia disorder patients treated with sunobinop showed better sleep efficiency compared to placebo, with increased perceived sleep ...

4.

ctv.veeva.com

ctv.veeva.com/study/study-of-sunobinop-on-alcohol-consumption-in-alcohol-use-disorder-1

Study of Sunobinop on Alcohol Consumption in Alcohol Use ...

The purpose of this study is to evaluate the efficacy of sunobinop compared to placebo on alcohol consumption in subjects with alcohol use disorder.

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06545929

Study of Sunobinop on Craving in Alcohol Use Disorder

Study Details | NCT06545929 | Study of Sunobinop on Craving in Alcohol Use Disorder | ClinicalTrials.gov.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11366868/

Evaluation of sunobinop for next-day residual effects in ...

Sunobinop was safe and generally well-tolerated, with sedation/somnolence occurring as the most common treatment-related adverse event (AE).