40 Participants Needed

Sunobinop for Alcoholism

MS
MI
Overseen ByMedical Information
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Imbrium Therapeutics
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

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.678910

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
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SunobinopExperimental Treatment1 Intervention
Group II: Placebo to match sunobinopPlacebo Group1 Intervention

Find a Clinic Near You

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.
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.
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%).
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]

References

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]
Safety and Tolerability of Pharmacological Treatment of Alcohol Dependence: Comprehensive Review of Evidence. [2018]
Safety and drinking outcomes among patients with comorbid alcohol dependence and borderline personality disorder treated with high-dose baclofen: a comparative cohort study. [2014]
Acute interaction of baclofen in combination with alcohol in heavy social drinkers. [2018]
A double-blind, placebo-controlled study of olanzapine in the treatment of alcohol-dependence disorder. [2019]
Chronic acamprosate eliminates the alcohol deprivation effect while having limited effects on baseline responding for ethanol in rats. [2018]
Development of tolerance upon repeated administration with the GABAB receptor positive allosteric modulator, COR659, on alcohol drinking in rodents. [2023]
Reducing effect of the novel positive allosteric modulator of the GABAB receptor, COR659, on binge-like alcohol drinking in male mice and rats. [2023]
Sodium oxybate in maintaining alcohol abstinence in alcoholic patients with and without psychiatric comorbidity. [2015]
[Misuse of alcohol and new drug treatments]. [2015]
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