A Dose-Escalation Study to Determine the Maximum Tolerated Dose of Arbaclofen Placarbil in Subjects With Alcohol Use Disorder

Completed · Phase 2 · Has a placebo group

Conditions studied: Alcohol Use Disorder

In brief

This study will determine the maximum tolerated dose (MTD) of arbaclofen placarbil (AP) in the treatment of subjects with Alcohol Use Disorder (AUD). For every two subjects receiving AP, one subject will receive placebo.

Key facts

Study ID

NCT02511886

Run by

Indivior Inc.

People needed

18

Starts

2015-09-01

Expected to finish

2016-01-01

Last updated by the study team

2017-01-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 to 65 years of age.
• Diagnosis of AUD confirmed by the Mini-International Neuropsychiatric Interview.
• For those requiring medical detoxification from alcohol, subjects will be required to have completed a program for detoxification from alcohol within 4 days prior to screening.
• Provide written informed consent prior to any study-specific procedures.
• Self-report of at least 2 heavy drinking days per week in each of the 4 weeks prior to the screening interview.
• Willing to abstain from drinking for the time he/she is participating in the study.
• Able to identify at least 1 "locator" person to assist study staff in tracking the subject for the non-residential clinic days.
• Able to read, speak, and understand English and be willing to cooperate with study procedures.
• For female subjects, women of childbearing potential must have a negative pregnancy test prior to enrollment and must agree to use a medically acceptable means of contraception from screening through at least 3 months after the last dose of IMP. Male subjects with female partners of childbearing potential must agree to use medically acceptable contraception from informed consent through at least 3 months after the last dose of IMP. Male subjects must also agree not to donate sperm during the study and for 3 months after receiving the last dose of IMP (Investigational Medicinal Product).

You may not qualify if…

• Has present symptoms or history of any of the following disorders:
• Schizophrenia
• Schizoaffective Disorder
• Delusional Disorder
• Bipolar I Disorder
• Any mood disorder with psychotic features or any psychotic disorder
• Anorexia Nervosa
• Bulimia Nervosa
• Post-Traumatic Stress Disorder that could interfere with the study
• Any Personality Disorder that could interfere with the study
• Current diagnosis of any substance use disorder, except for nicotine, cannabis (mild or moderate), or alcohol.
• Positive result for any prohibited medication.
• History of suicidal ideation within 30 days prior to providing written informed consent.
• History of seizures or delirium tremens.
• Intention to initiate or continue additional formal alcohol-related treatment, including pharmacotherapy, during the active treatment period.
• Have had inpatient treatment for a non-alcohol substance use disorder in the 12 weeks prior to informed consent.
• Total bilirubin >1.5× the upper limit of normal (ULN), alanine aminotransferase (ALT) >3×ULN, aspartate aminotransferase (AST) >3×ULN, serum creatinine >2×ULN, international normalized ratio (INR) >1.5×ULN, lipase >3×ULN, amylase >3×ULN, or any abnormal pancreatic enzyme value above ULN that is associated with clinically significant active pancreatic disorder.
• Creatinine clearance of <80 mL/min, as calculated according to the Cockcroft-Gault equation.
• Hemoglobin at screening of <11.5 g/dL (for females) or <12.5 g/dL (for males).
• Body mass index (BMI) >30.
• Diagnosed with unstable medical disorders that could increase the potential risk of study treatment or interfere with study participation, including the following:
• Abnormal cardiac conditions, including:
• Uncontrolled hypertension.
• History of myocardial infarction in the last year or any prior history of myocardial infarction with active complication.
• Syncopal event within the past year.

Where it is running

• Research Centers of America — Oakland Park, Florida, United States

Full record on ClinicalTrials.gov

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