Is NCT05207085 recruiting in New Haven, CT?

Yes, NCT05207085 is currently recruiting participants at its New Haven, CT location. This trichotillomania (hair-pulling disorder) clinical trial is actively enrolling qualified participants.

Is participation in this New Haven clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Trichotillomania (Hair-Pulling Disorder) Clinical Trial in New Haven, CT

Q: How do I join the trichotillomania (hair-pulling disorder) clinical trial in New Haven?

To join this clinical trial in New Haven, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Trichotillomania (Hair-Pulling Disorder) Study in New Haven

This trial aims to evaluate the efficacy, safety and tolerability of valbenazine, titrated to the subject's optimal dose of 40mg or 80mg, administered once daily, for 12 weeks, for the treatment of trichotillomania (TTM) in a double blind placebo controlled design study. After week 12, subjects will begin a 12-week, open-label portion of the study. During the open-label portion of the study, all subjects will receive the study drug at their optimal dose. The primary endpoint of these studies will be the change from baseline of placebo vs. active scores utilizing the Massachusetts General Hospital Hairpulling Scale (MGH-HPS) at the end of Week 12.

Sponsor: Yale University

Who Can Participate

Inclusion Criteria

Have documentation of written and witnessed consent from the subject.

Male or female adult between the ages of 18-65, inclusive.

Be in good health as determined by medical history, physical examination, laboratory assessments and 12-lead ECG.

On stable psychiatric medication regime of 4 weeks prior to beginning the trial and not anticipating changes during the trial.

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).

Female subjects must have a negative urine pregnancy test at screening, baseline and weeks 2, 4, 8, 12, 14, 16, 20, 24 and 26.

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.

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.

Have symptoms that cause marked distress or significant impairment in occupational and/or social function.

Have a stable psychiatric status (TTM) as clinically determined by the investigator.

Meet DSM-5 criteria for TTM.

Significant current TTM symptoms: 12 or greater score on MGH-HPS.

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 TTM 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 TTM/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 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.

Have a blood loss ≥250 mL or donated blood within 56 days or donated plasma within 7 days of Day 1 (baseline).

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 a history of or suspected poor compliance in clinical research studies.

Have previous experience with valbenazine or previously participated in a valbenazine clinical study.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New Haven?

Yes, this clinical trial (NCT05207085) has an active research site in New Haven, CT that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Trichotillomania (Hair-Pulling Disorder) Treatment Options in New Haven, CT

If you're searching for trichotillomania (hair-pulling disorder) treatment options in New Haven, CT, this clinical trial (NCT05207085) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New Haven research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced trichotillomania (hair-pulling disorder) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all trichotillomania (hair-pulling disorder) clinical trials near you to find additional studies recruiting in your area.

Trichotillomania (Hair-Pulling Disorder) Clinical Trial in New Haven, CT

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