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Study of Sunobinop on Alcohol Consumption in Alcohol Use Disorder
EU CTIS ID: 2024-517105-85-00
What this study is testing
To evaluate whether sunobinop compared to placebo will reduce percent heavy drinking days
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male and females age >= 18 years.
- Diagnosis of moderate or severe alcohol use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders 5th edition Text Revision (DSM-V-TR) and confirmed by Structured Clinical Interview for DSM Disorders (SCID-5).
- 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 as assessed by Timeline Followback interview. HDD is defined as 4 or more standard drinks per day for females and 5 or more standard drinks per day for males. A standard drink is defined as 12 ounces (~355 mL) of 5% beer, 5 ounces (150 mL) of 12% wine, or 1.5 ounces (44mL) of 80-proof (40%) distilled spirits.
- Males and females: - A male subject with a heterosexual partner who is a woman of childbearing potential must either be vasectomized or agree to use condoms during the trial and for 30 days following the treatment period. - A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: * Not a woman of childbearing potential (WOCBP). Females who are postmenopausal mush have beem postmenopausal > = 1 year and have elevated serum FSH. * Female subjects of childbearing potential must agree to use a reliable method of contraception with a failure rate of less than 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra uterine devices [IUDs], heterosexual abstinence or vasectomized partner during the trial and for 30 days following the tratment period. A female is considered to be of childbearing potential unless she has had a hysterectomy, has undergone tubal litigation or is at least one year post-menopausal with elevated serum FSH.
- Willing to be compliant with the protocol (including dosing instructions, daily electronic diary completion and clinic visit attendance) and able to read and understand questionnaires.
You likely can't join if
- Subjects that meet current DSM-5 criteria for moderate or severe substance use disorder other than alcohol and nicotine.
- Females who are pregnant or lactating or planning to become pregnant during the study.
- Subjects who have ongoing legal issues that require abstinence from alcohol or have legal charges that have the risk of incarceration during the study period.
- Subjects that do not have a stable living situation or plan to move during the study period.
- Subjects who, in the opinion of the investigator, are unsuitable to participate in this study for any other reason.
- Subjects with clinically unstable medical, neurologic or psychiatric conditions, or any other medical condition that, in the investigator's opinion, is inadequately treated and precludes entry into the study. Minor or well-controlled medical conditions that in the opinion of the investigator would not affect the subject's safety or interfere with study assessments may be allowed.
See the full eligibility criteria
Who can join
- Male and females age >= 18 years.
- Diagnosis of moderate or severe alcohol use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders 5th edition Text Revision (DSM-V-TR) and confirmed by Structured Clinical Interview for DSM Disorders (SCID-5).
- 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 as assessed by Timeline Followback interview. HDD is defined as 4 or more standard drinks per day for females and 5 or more standard drinks per day for males. A standard drink is defined as 12 ounces (~355 mL) of 5% beer, 5 ounces (150 mL) of 12% wine, or 1.5 ounces (44mL) of 80-proof (40%) distilled spirits.
- Males and females: - A male subject with a heterosexual partner who is a woman of childbearing potential must either be vasectomized or agree to use condoms during the trial and for 30 days following the treatment period. - A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: * Not a woman of childbearing potential (WOCBP). Females who are postmenopausal mush have beem postmenopausal > = 1 year and have elevated serum FSH. * Female subjects of childbearing potential must agree to use a reliable method of contraception with a failure rate of less than 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra uterine devices [IUDs], heterosexual abstinence or vasectomized partner during the trial and for 30 days following the tratment period. A female is considered to be of childbearing potential unless she has had a hysterectomy, has undergone tubal litigation or is at least one year post-menopausal with elevated serum FSH.
- Willing to be compliant with the protocol (including dosing instructions, daily electronic diary completion and clinic visit attendance) and able to read and understand questionnaires.
What rules you out
- Subjects that meet current DSM-5 criteria for moderate or severe substance use disorder other than alcohol and nicotine.
- Females who are pregnant or lactating or planning to become pregnant during the study.
- Subjects who have ongoing legal issues that require abstinence from alcohol or have legal charges that have the risk of incarceration during the study period.
- Subjects that do not have a stable living situation or plan to move during the study period.
- Subjects who, in the opinion of the investigator, are unsuitable to participate in this study for any other reason.
- Subjects with clinically unstable medical, neurologic or psychiatric conditions, or any other medical condition that, in the investigator's opinion, is inadequately treated and precludes entry into the study. Minor or well-controlled medical conditions that in the opinion of the investigator would not affect the subject's safety or interfere with study assessments may be allowed.
- Subjects at significant risk of acute withdrawal syndrome in the opinion of the investigator; or score >8 on the Clinical Institute Withdrawal Assessment of Alcohol Scale Revised (CIW A-Ar) at screening; or had prior seizures (other than febrile seizure) or other conditions that would place the patient at increased risk of seizure; or are taking anticonvulsants.
- Subjects who are prescribed prohibited medications for medical or psychiatric indications (see Section 6.6.1.). NOTE: Subjects should not discontinue medically indicated treatments to meet criteria for study participation.
- Subjects with clinically significant kidney disease in the opinion of the investigator or screening estimated glomerular filtration rate (eGFR) < 60mL/min/1.73 m2
- Subjects with clinically significant liver disease in the opinion of the investigator or screening value > = 3 times the upper limit of normal for aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGTP) or a screening bilirubin value > = 1.5 mg/dL.
- Subjects with a screening electrocardiogram showing a QTcF value (QT data corrected for heart rate using the Fridericia formula) of >= 470 msec for females or >= 450 msec for males, or other ECG findings that, in the investigator's opinion, would preclude participation in the study.
- Subjects with suicidal ideation associated with actual intent and a method or plan in the past 1 year ("Yes" answer on items 4 or 5 of the C-SSRS); subjects with active suicidal ideation ("Yes" answer on item 2 or 3 of the C-SSRS); a previous history of suicidal behaviors in the past 2 years ("Yes" answer to any of the suicidal behavior items of the C-SSRS), or any lifetime history of serious or recurrent suicidal behavior.
- Subjects that have used an investigational drug within 30 days (90 days for biologics) or participated in an investigational study within 30 days prior to screening.
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.