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

40 Participants Needed

Trial Summary

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 Sunobinop safe for human use?

There is no specific safety data available for Sunobinop, but sodium oxybate, a similar treatment for alcohol use disorder, has been shown to have a good safety profile in large studies, with main side effects being temporary dizziness and vertigo, and serious side effects being rare. ^{1 2 3 4 5}

How does the drug Sunobinop differ from other treatments for alcoholism?

Sunobinop is unique because it may work as a positive allosteric modulator of the GABAB receptor, similar to COR659, which has shown potential in reducing alcohol intake by affecting the brain's response to alcohol. This mechanism is different from other treatments like acamprosate or sodium oxybate, which have different ways of helping with alcohol dependence. ^{6 7 8 9 10}

What is the purpose of this trial?

The purpose of this study is to evaluate the efficacy of sunobinop compared to placebo on alcohol craving in subjects with moderate to severe alcohol use disorder and these subjects are seeking treatment.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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 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]

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]

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]

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]

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) 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]

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]

References

1. England 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. [2020]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Safety and Tolerability of Pharmacological Treatment of Alcohol Dependence: Comprehensive Review of Evidence. [2018]

3. England 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. [2014]

4. England pubmed.ncbi.nlm.nih.gov

Acute interaction of baclofen in combination with alcohol in heavy social drinkers. [2018]

5. England pubmed.ncbi.nlm.nih.gov

A double-blind, placebo-controlled study of olanzapine in the treatment of alcohol-dependence disorder. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Chronic acamprosate eliminates the alcohol deprivation effect while having limited effects on baseline responding for ethanol in rats. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Development of tolerance upon repeated administration with the GABAB receptor positive allosteric modulator, COR659, on alcohol drinking in rodents. [2023]

8. Germany 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. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Sodium oxybate in maintaining alcohol abstinence in alcoholic patients with and without psychiatric comorbidity. [2015]

10. France pubmed.ncbi.nlm.nih.gov

[Misuse of alcohol and new drug treatments]. [2015]