2024-517105-85-00RecruitingPhase 2
A Two-part, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Study to Evaluate Impact of Sunobinop (V117957) on Alcohol Consumption (Part A) and Alcohol Craving (Part B) in Subjects Diagnosed with Moderate to Severe Alcohol Use Disorder and Seeking Treatment
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Imbrium Therapeutics LP
- Enrollment
- 100
- Locations
- 3
- Primary Endpoint
- Percent heavy drinking days (HDD) as assessed using Timeline Followback interview.
Study Overview
Brief Summary
To evaluate whether sunobinop compared to placebo will reduce percent heavy drinking days
Study Design
- Allocation
- Not Applicable
- Primary Purpose
- Safety Follow-up
- Masking
- None
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Percent heavy drinking days (HDD) as assessed using Timeline Followback interview.
Percent heavy drinking days (HDD) as assessed using Timeline Followback interview.
Secondary Outcomes
- Number of standard unit drinks as assessed using Timeline Followback interview.
- Percent of days drinking (PDD) as assessed using Timeline Followback interview.
- WHO Risk Level of alcohol consumption as assessed using Timelines Followback interview.
Investigators
Medical Information
Scientific
Imbrium Therapeutics LP
Study Sites (3)
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