Valbenazine for Trichotillomania in Adults
- Study HIC#:2000034993
- Last Updated:02/28/2025
If you are an adult with trichotillomania, you may be eligible to participate in a research study run by the Yale School of Medicine. This study will examine the efficacy of Valbenazine for the treatment of trichotillomania. Valbenazine is a dopamine-depleting agent that is currently FDA-approved for tardive dyskinesia and has a relatively safe side-effect profile in initial trials.
While enrolled in the trial, you will receive regular psychiatric and medical assessments of symptoms at no cost. Additionally, you will receive a stipend of up to $590 over the course of 26 weeks for your participation.
If you are interested in the trial or wish to learn more, please do not hesitate to contact us by phone at 203-432-3940 or 203-737-4809, or email at blochresearch@yale.edu if you have any questions about the trial.
- Age18 years - 65 years
- GenderBoth
Contact Us
For more information about this study, including how to volunteer, contact:
Victor Avila-Quintero
- Phone Number: 1-203-432-3940
Help Us Discover!
You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.
Eligibility Criteria
Inclusion Criteria:
- Adult between the ages of 18 to 65 years old, any gender.
- On stable psychiatric medication regime of 4 weeks prior to beginning the trial and not anticipating changes during the trial
- Participants of child-bearing potential must agree to use contraception (condoms for men, birth control pill or diaphragm for women) consistently from screening until 30 days (female) or 90 days (male) after the last dose of the study drug.
- Female participants must have a negative urine pregnancy test at Day 1.
- Negative urine drug screen (negative for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, or opiates) at screening and baseline. Subjects on stable doses of prescribed and supervised (not as needed) benzodiazepines, opiates or psychostimulants (participants with ADHD) can participate in the study.
- Have symptoms of Trichotillomania that cause marked distress or significant impairment in occupational and/or social function.
Exclusion Criteria:
- Comorbid bipolar disorder, psychotic disorder, substance use disorder, developmental disorder or intellectual disability (IQ<70).
- Recent changes in medications (less than 4 weeks) in other medications that have potential effects on Trichotillomania severity. Medication change is defined to include dose changes or medication discontinuation.
- Currently taking antipsychotic medications or other medications that affect the dopamine system (e.g. psychostimulant medications).
- Recent changes in behavior treatment (less than 4 weeks) or initiation of therapy (within 12 weeks) for Trichotillomania/Obsessive Compulsive Disorder (OCD).
- Taking co-medications (over the counter or prescription) that may have a drug interaction with Valbenazine as described in the United States Prescribing Information for INGREZZA. Patients who are taking co-medications with the potential to cause QT prolongations will not be excluded unless their ECG shows QT prolongation already present.
- Positive pregnancy test or drug screening test.
- Currently pregnant or lactating.
- Significant medical comorbidity.
- Excessive use of tobacco and/or nicotine-containing products (based on the investigator's assessment or more than 1½ pack of cigarettes per day, 1 can of chewing/dipping tobacco per day, 54mg of nicotine-containing smoking cessation products per day, or any nicotine products or combination of products that exceed 54mg per day) within 30 days of screening.
- History of substance (drug or alcohol) dependence or abuse within 3 months before Baseline, as defined by DSM-5 criteria for Substance Use Disorder.
- Known history of neuroleptic malignant syndrome.
- Known history of long QT syndrome or cardiac arrhythmia.
- Have a blood loss ≥250 mL or donated blood within 56 days or donated plasma within 7 days of Day 1.
- Have a significant risk of suicidal or violent behavior based on prior medical history and clinical judgement.
- Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors (e.g., tetrabenazine).
- Have previous experience with Valbenazine or previously participated in a Valbenazine clinical study.