Could a Once-Daily pill curb the urge to pull hair?
NCT ID NCT05207085
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a daily medication called valbenazine can reduce hair-pulling in adults with trichotillomania. About 20 people will receive either the drug or a placebo for 12 weeks, then everyone gets the drug for another 12 weeks. The goal is to see if the drug safely eases symptoms and improves control over pulling urges.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2024
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Have documentation of written and witnessed consent from the subject. 2. Male or female adult between the ages of 18-65, inclusive. 3. Be in good health as determined by medical history, physical examination, laboratory assessments and 12-lead ECG. 4. On stable psychiatric medication regime of 4 weeks prior to beginning the trial and not anticipating changes during the trial. 5. Subjects 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. A female subject of childbearing potential is defined as a female capable of becoming pregnant, which includes subjects who have had their first menstrual cycle (i.e., menarche) and are not surgically sterile (i.e., bilateral oophorectomy, hysterectomy or bilateral tubal ligation for at least 3 months prior to screening) or have not experienced menopause and subsequently are no longer of childbearing potential. A male subject of childbearing potential is defined as a subject who has reached spermarche and has not been vasectomized for at least 3 months prior to screening. Subjects who practice total abstinence from sexual intercourse as the preferred lifestyle are not required to use contraception (periodic abstinence is not acceptable). 6. Female subjects must have a negative urine pregnancy test at screening, baseline and weeks 2, 4, 8, 12, 14, 16, 20, 24 and 26. 7. Negative urine drug screen (negative for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, or opiates) at screening, baseline and weeks 2, 4, 8, 12, 14, 16, 20, 24 and 26. Subjects on stable doses of prescribed and supervised (not as needed) benzodiazepines, opiates or psychostimulants (participants with ADHD) can participate in the study. Results from a positive drug screen will be discarded. 8. Be willing to adhere to the study regime and study procedures described in the protocol and informed consent forms, including all requirements at the study center and return for the follow-up visit. 9. Have symptoms that cause marked distress or significant impairment in occupational and/or social function. 10. Have a stable psychiatric status (TTM) as clinically determined by the investigator. 11. Meet DSM-5 criteria for TTM. 12. Significant current TTM symptoms: 12 or greater score on MGH-HPS. Exclusion Criteria: 1. Comorbid bipolar disorder, psychotic disorder, substance use disorder, developmental disorder or intellectual disability (IQ\<70). 2. Recent changes in medications (less than 4 weeks) in other medications that have potential effects on TTM severity. Medication change is defined to include dose changes or medication discontinuation. 3. Currently taking antipsychotic medications or other medications that affect the dopamine system (e.g. psychostimulant medications). 4. Recent changes in behavior treatment (less than 4 weeks) or initiation of therapy (within 12 weeks) for TTM/Obsessive Compulsive Disorder (OCD). 5. 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. 6. Positive pregnancy test or drug screening test. 7. Currently pregnant or lactating. 8. Significant medical comorbidity. 9. 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. 10. History of substance (drug or alcohol) dependence or abuse within 3 months before Baseline, as defined by DSM-5 criteria for Substance Use Disorder. 11. Known history of neuroleptic malignant syndrome. 12. Known history of long QT syndrome or cardiac arrhythmia. 13. Have a screening or Day 1 average triplicate ECG corrected QT interval using Fridericia's formula (QTcF) of \>450msec or the presence of any clinically significant cardiac abnormality. 14. Have a blood loss ≥250 mL or donated blood within 56 days or donated plasma within 7 days of Day 1 (baseline). 15. Have a significant risk of suicidal or violent behavior based on prior medical history and clinical judgement. 16. Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors (e.g., tetrabenazine). 17. Have a history of or suspected poor compliance in clinical research studies. 18. Have previous experience with valbenazine or previously participated in a valbenazine clinical study.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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Contacts and locations
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Yale Child Study Center
RECRUITINGNew Haven, Connecticut, 06520, United States
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