Sunobinop for Alcoholism

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: 2

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called sunobinop to determine its effectiveness in reducing alcohol cravings in individuals with moderate to severe alcohol use disorder. Participants will receive either sunobinop or a placebo (a harmless pill with no active medicine) to compare outcomes. The trial targets those actively seeking help for their alcohol use and who have experienced four or more heavy drinking days each week for the past month. This trial may suit individuals looking for treatment and willing to assist researchers in exploring new options. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

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

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

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

Research has shown that sunobinop is generally safe and well-tolerated. In studies, participants who took sunobinop did not experience any serious side effects. It proved safe at doses up to 2 mg and had minimal effects the next day, allowing participants to feel fine. Overall, sunobinop appears safe enough for further study. ^{1 2 3 4 5}

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

Researchers are excited about Sunobinop for treating alcoholism because it offers a unique approach compared to current options like naltrexone and acamprosate. Unlike these traditional treatments, which primarily focus on neurotransmitter modulation, Sunobinop targets specific neural pathways associated with alcohol craving and reward. This novel mechanism of action could potentially reduce alcohol dependence more effectively by directly addressing the brain circuits involved in addiction. Plus, Sunobinop's targeted approach may lead to fewer side effects, making it a promising option for those seeking new solutions to manage alcoholism.

What evidence suggests that sunobinop might be an effective treatment for alcohol use disorder?

Research shows that sunobinop, which participants in this trial may receive, may help reduce the urge to drink in people with alcohol use disorder. Previous studies found that sunobinop is usually safe and well-tolerated, with no serious side effects reported. It has also been linked to better sleep, which might help manage alcohol cravings. Although more research is needed, these early findings suggest sunobinop could be a promising treatment option for managing alcohol use disorder. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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

Inclusion Criteria

* Diagnosis of moderate or severe alcohol use disorder.

* Currently seeking treatment for alcohol use disorder.

* Has 4 or more heavy drinking days (HDD) in each of the 4 weeks prior to baseline visit.

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 craving

2 weeks

2 visits (in-person)

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 cravings for individuals with alcohol use disorder. It aims to see if Sunobinop helps more than a non-active pill.

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

Pharmacological treatments for alcohol use disorders (AUD), such as acamprosate, naltrexone, nalmefene, and disulfiram, are effective but underused, highlighting the need for better implementation despite their proven efficacy.

Each medication has a distinct safety profile that must be carefully considered alongside individual patient circumstances, including their drinking patterns and any comorbid conditions, to optimize treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Tolerability of Pharmacological Treatment of Alcohol Dependence: Comprehensive Review of Evidence. Sinclair, JM., Chambers, SE., Shiles, CJ., et al.[2018]

In a study involving 18 heavy social drinkers, baclofen was found to be safe when combined with alcohol, showing only modest increases in heart rate and blood pressure without any reported adverse effects.

Baclofen did not enhance the positive effects of alcohol or increase alcohol craving, indicating it has minimal abuse potential and is well tolerated in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute interaction of baclofen in combination with alcohol in heavy social drinkers. Evans, SM., Bisaga, A.[2018]

In a 12-week clinical trial involving 60 alcohol-dependent patients, olanzapine did not significantly reduce the relapse rate to heavy drinking compared to placebo, with 37.9% of patients on olanzapine relapsing versus 29% on placebo.

Olanzapine was well tolerated with low rates of adverse events, and it did not negatively affect biochemical markers of heavy drinking or liver function, indicating it is safe for use in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blind, placebo-controlled study of olanzapine in the treatment of alcohol-dependence disorder. Guardia, J., Segura, L., Gonzalvo, B., et al.[2019]

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]

Sodium oxybate (SMO) has been shown to have a good safety profile for treating alcohol use disorder (AUD), based on data from 3 large clinical studies with 520 participants and 43 earlier studies involving 2547 participants.

The most common side effects were temporary dizziness and vertigo, with serious adverse events being rare and no deaths linked to SMO, indicating it is a safe option for patients without psychiatric issues or poly-drug use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-marketing and clinical safety experience with sodium oxybate for the treatment of alcohol withdrawal syndrome and maintenance of abstinence in alcohol-dependent subjects. Addolorato, G., Lesch, OM., Maremmani, I., et al.[2020]

COR659, a positive allosteric modulator of the GABAB receptor, significantly reduced alcohol intake in both male C57BL/6J mice and Sardinian alcohol-preferring rats, with reductions of up to 70-80% compared to vehicle treatment.

Despite its initial effectiveness, tolerance to the effects of COR659 developed quickly, diminishing its ability to suppress alcohol consumption over subsequent sessions, which could limit its therapeutic use in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of tolerance upon repeated administration with the GABAB receptor positive allosteric modulator, COR659, on alcohol drinking in rodents. Lorrai, I., Shankula, C., Marquez Gaytan, J., et al.[2023]

Sodium oxybate (SMO) effectively promotes alcohol abstinence in both alcohol-dependent patients with and without psychiatric co-morbidities, showing no significant difference in abstinence rates between the two groups after 12 weeks of treatment.

However, patients with psychiatric co-morbidities experienced a higher frequency of craving for SMO and a notable risk of abuse, suggesting that SMO may not be suitable for individuals with such conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sodium oxybate in maintaining alcohol abstinence in alcoholic patients with and without psychiatric comorbidity. Caputo, F., Francini, S., Brambilla, R., et al.[2015]

In a study of 204 patients with alcohol dependence treated with high-dose baclofen, those with borderline personality disorder (BPD) experienced significantly higher rates of heavy drinking days (74.3% vs. 41.7%) and serious adverse events (65.2% vs. 6.5%) compared to controls without psychiatric history.

The findings suggest that the benefit/risk balance of high-dose baclofen is unfavorable for patients with comorbid BPD, as they also had a higher rate of treatment discontinuation due to adverse events (52.2% vs. 8.6%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and drinking outcomes among patients with comorbid alcohol dependence and borderline personality disorder treated with high-dose baclofen: a comparative cohort study. Rolland, B., Valin, T., Langlois, C., et al.[2014]

Acamprosate effectively reduces ethanol consumption in male Wistar rats, indicating its potential to help prevent relapse in alcoholics, as shown by a significant decrease in alcohol intake after acute administration of 400 mg/kg.

Chronic administration of lower doses (100 and 200 mg/kg) of acamprosate prevented the typical increase in ethanol consumption following a period of abstinence, without affecting water consumption, suggesting its selective action on alcohol-related behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic acamprosate eliminates the alcohol deprivation effect while having limited effects on baseline responding for ethanol in rats. Heyser, CJ., Schulteis, G., Durbin, P., et al.[2018]

Currently, three drugs are available in France for preventing relapse in alcohol-dependent patients, but their efficacy is limited, highlighting the need for new treatment options.

Several other medications, including baclofene and nalmefene, are being evaluated for their potential in treating alcohol dependence, suggesting a shift towards personalized treatment strategies that focus on reducing consumption rather than solely achieving abstinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Misuse of alcohol and new drug treatments]. Paille, F.[2015]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06545916?term=V117957&rank=5

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

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. clinicaltrials.gov clinicaltrials.gov/study/NCT06545929

Study of Sunobinop on Craving in Alcohol Use Disorder Study Overview. The purpose of this study is to evaluate the efficacy of sunobinop compared to placebo on alcohol craving in subjects with moderate to severe ...

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

Evaluation of sunobinop for next-day residual effects in ... Sunobinop was generally well-tolerated in both healthy subjects and patients, with no deaths, serious adverse events, or discontinuations due to ...

5. imbriumthera.com imbriumthera.com/news/imbrium-therapeutics-completes-first-patient-dosed-in-phase-2-study-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, ...

6. accp1.onlinelibrary.wiley.com accp1.onlinelibrary.wiley.com/doi/10.1002/cpdd.1394

Safety, Tolerability, and Pharmacokinetics of Single‐ and ... Sunobinop was generally well-tolerated and safe across the range of doses evaluated and presents a clinical profile suitable for continued development.

7. go.drugbank.com go.drugbank.com/drugs/DB18955

Sunobinop: Uses, Interactions, Mechanism of Action Sunobinop is under investigation in clinical trial NCT04035200 (Safety, Tolerability and Efficacy Study of V117957 in Subjects With Insomnia ...