| Eligibility |
- INCLUSION CRITERIA:
- Alcohol Use Disorder (Minimum 2 symptoms on a validated diagnostic tool e.g., the
Mini-International Neuropsychiatric Interview (MINI) or the Structured Clinical
Interview for DSM Disorders (SCID)
- Male or female individuals 18-70 years old (inclusive)
- Able to speak, read, write and understand English
- Most recent urine drug test for benzodiazepines, barbiturates, cocaine metabolites,
morphine, oxycodone, methadone, amphetamine, & buprenorphine is negative.
- Most recent Clinical Institute Withdrawal Assessment for Alcohol - revised (CIWA-Ar)
score is less than or equal to 8
Males only:
-Males agrees agree to sexual abstinence or to use a reliable method of birth control
during the study and 3 months following the last dose of the study drug. Acceptable methods
of birth control may include: 1) condom with spermicide; 2) diaphragm with spermicide; or
3) female condom with spermicide.
Females only:
-Women of child-bearing potential may participate in the study:
- if they test negative for pregnancy (based on a urine pregnancy test) prior to
initiation of treatment
- they must also agree to use either 1 highly effective method of contraception or a
combination of 2 effective methods of contraception during the study.
- Highly effective method may include hormonal contraceptives (e.g., combined oral
contraceptives, patch, vaginal ring, injectables, and implants); intrauterine
device or/ intrauterine system; vasectomy and tubal ligation.
- Effective methods may include barrier methods of contraception (e.g., male
condom, female condom, cervical cap, diaphragm, contraceptive sponge)
Women may choose to use a double-barrier method of contraception. Barrier methods without
concomitant use of a spermicide are not reliable or an acceptable method. Thus, each
barrier method must include use of a spermicide. It should be noted that the use of male
and female condoms as a double-barrier method is not considered acceptable due to the high
failure rate when these methods are combined.
OR
-Women not of child-bearing potential may participate in the study and include those who
have
- spontaneous amenorrhea for at least 12 months, not induced by a medical condition such
as anorexia nervosa and not taking medications that induced amenorrhea e.g., oral
contraceptives, hormones, gonadotropin-releasing hormone, anti-estrogens, selective
estrogen receptor modulators, or chemotherapy; or
- spontaneous amenorrhea for 6 to 12 months and a follicle-stimulating hormone (FSH)
level greater than 40 mIU/mL; or
- women with a history of hysterectomy or bilateral oophorectomy must be at least 40
years of age and FSH >40 mIU/mL.
EXCLUSION CRITERIA:
- Lifetime clinical diagnosis of schizophrenia or bipolar disorder
- BMI < 18.5 kg/m(2) and weight less than 60 Kg (both must be met)
- BMI >= 40 kg/m(2)
- History of epilepsy and/or seizures
NOTE: individuals who have a history of alcohol withdrawal seizures may be in the study as
long as they have been abstinent from alcohol for at least 2 weeks prior to consent and
during that period of abstinence, there were no seizure episodes (otherwise, participant
remains not eligible).
- Creatinine greater than or equal to 2 mg/dL, AST or ALT > 1.5 times the upper normal
limit, hemoglobin <10.5 g/dl
- Diagnosis of liver cirrhosis
- Clinically significant history or current eating, pituitary or adrenal gland disorders
or disorder of gastric motility as judged by a study clinician as determined from
medical history and/or current clinical screening information
- Current thyroid disorders that are not stable on dose of FDA-approved medications for
that disease, as judged by a study clinician as determined from medical history and/or
current clinical screening information. A pre-existing stable medical condition is
defined as a disease not requiring significant change in therapy or hospitalization
for worsening disease during the past 3 months.
- Clinically significant abnormal 12-Lead ECG
- QTcF > 450 msec for men and > 470 msec for women
- Family history of Long QT Syndrome.
- Patients on weight loss medications within 30 days of dosing
- Patients with a history of bariatric surgery
- Diagnosis of diabetes and currently on medication
- Unable to refrain from or anticipates the use of:
- Any drugs known to be significant inhibitors of cytochrome P450 (CYP)3A enzymes
and/or P-glycoprotein (P-gp) including regular consumption of grapefruit or
grapefruit juice for 14 days prior to the first dose of study medication.
[medications like acetaminophen (up to 2 g per 24-hour period) and ibuprofen may be
permitted during the study]
- Any drugs known to be significant inducers of CYP3A enzymes and/or P-gp, including St.
John s Wort, for 28 days prior to the first dose of study medication.
- Any medications that prolong the QTcF, unless the patient has been stable on the
medication for at least 3 months and has a QTcF equal to or < 450 msec
- Benzodiazepines. If a participant received a benzodiazepine as part of their treatment
during the alcohol detoxification, then s/he can still be enrolled. However, 5
half-lives (for that benzodiazepine) will be required to elapse before the anticipated
date of first study drug administration
- Currently taking simvastatin >10 mg per day, atorvastatin >20 mg per day, or
lovastatin >20 mg per day.
The doses of these statins in combination products should not exceed these defined dose
levels.
- Patients with a history of statin-induced myopathy/rhabdomyolysis.
- Vision is unable to be corrected to (Snellen) 20/100
- Clinically-significant history of motion or car sickness, or history of vestibular
disorders
- FIB-4 Score > 1.30
- Any other reason or clinical condition for which the PI or the MAI or other study
clinician will consider unsafe for a possible participant to participate in this study
These criteria are based on the target population for this study. Other criteria are
consistent with an ongoing study that GLWL Research Inc. is conducting with GLWL-01 in
patients with Prader-Willi Syndrome (ClinicalTrials.gov NCT03274856).
|
