A Study in Patients With Trichotillomania

Inclusion Criteria

• •1. Adult, female or male, 18-45 years of age, inclusive at screening.
• •2. Provided signed written informed consent with willingness and ability to comply with all aspects of the protocol.
• •3. Diagnosis of current TTM based on Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria and confirmed using the clinician-administered MINI-TTM. In addition, subjects should:
• •1. Have a history of TTM for at least one year
• •2. Have a history of daily hair pulling for at least 6 months prior to the first dose
• •4. Except for SSRIs or SNRIs, has not used any psychoactive medications including, but not limited to, other antidepressants, anxiolytics, mood stabilizers, anti-psychotics, benzodiazepines, stimulants, sulfasalazine, and St. John's Wort 30 days prior to first dose. Subjects will be allowed to maintain background therapy with SSRIs or SNRIs if on stable regimen for a minimum of 90 days prior to first dose and there are no anticipated changes to the SSRI/SNRI during course of trial.
• •5. Has not used N-acetylcysteine for at least 90 days prior to the first dose.
• •6. Has not used gemfibrozil or repaglinide for 1 week prior to the first screening visit.
• •7. Medically healthy with no clinically significant findings in medical history, physical examination, laboratory profiles, vital signs, or ECGs, as deemed by the Principal Investigator (PI) or designee.
• •8. For a female of childbearing potential: either be sexually inactive (abstinent as a life style) for 28 days prior to the first dosing and throughout the study or be using one of the following acceptable birth control options:
• •* Oral contraception for at least 3 months prior to the first dosing along with either a physical (e.g., condom, diaphragm) or a chemical (e.g., spermicide) barrier method from the time of screening and throughout the study
• •* IUD (either hormone-releasing or non-hormone releasing) for at least minimum duration per current labeling along with either a physical (e.g., condom, diaphragm) or a chemical (e.g., spermicide) barrier method from the time of screening and throughout the study
• •* Depo contraception for at least minimum duration per current labeling prior to the first dosing along with either a physical (e.g., condom, diaphragm) or a chemical (e.g., spermicide) barrier method from the time of screening and throughout the study
• •* Double physical barrier method (e.g., condom and diaphragm) from 14 days prior to the first dose and throughout the study
• •* Physical plus chemical barrier method (e.g., condom with spermicide) from 14 days prior to the first dose and throughout the study.
• •In addition, female subjects of childbearing potential will be advised to remain sexually inactive or to keep the same birth control method for at least 30 days following the last dose.
• •9. Female of non childbearing potential: must have undergone one of the following sterilization procedures, at least 6 months prior to the first dose:
• •* hysteroscopic sterilization;
• •* bilateral tubal ligation or bilateral salpingectomy;
• •* hysterectomy;
• •* bilateral oophorectomy; Or be postmenopausal with amenorrhea for at least 1 year prior to the first dose with serum follicle stimulating hormone levels consistent with postmenopausal status or have medically documented history of biological or congenital sterility.
• •10. A non vasectomized, male subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 30 days beyond the last dose of study drug/placebo.
• •11. If male, must agree not to donate sperm from the first dose until 30 days after the last dose administration.
• •12. Must be able to fluently read and write in English.
• •13. Understands the study procedures in the informed consent form (ICF) and is willing and able to comply with the protocol.