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Not yet recruiting NCT07282769

Semaglutide (Wegovy) Treatment for Trichotillomania

Phase II Interventional Trichotillomania (Hair-Pulling Disorder) Trichotillomania Hair Pulling Disorder Hair Pulling

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Semaglutide.
Who it may be relevant to
Registry conditions: Trichotillomania (Hair-Pulling Disorder), Trichotillomania, Hair Pulling Disorder, Hair Pulling. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Once Weekly Semaglutide Treatment of Trichotillomania: An Open-Label Study

Overview

This research study is testing the effectiveness and safety of semaglutide (Wegovy) in people with trichotillomania, also known as hair-pulling disorder.

Detailed description

The goal of the proposed study is to evaluate the efficacy and safety of semaglutide in individuals with trichotillomania. The hypothesis to be tested is that semaglutide will reduce urges to pull hair and pulling behavior and will be well tolerated in participants with trichotillomania. The proposed study will provide needed pilot data on the treatment of a disabling disorder that currently lacks available options for pharmacological treatment.

The investigators will conduct an open-label pharmacotherapy trial in 10 individuals with trichotillomania. Participants with trichotillomania will be started and continued on medication during an 8-week treatment phase. The study will be the first to use a once weekly Glucagon-like peptide 1 (GLP-1) receptor agonist pharmacological intervention to target urges in trichotillomania and thereby has the potential to set a new standard of care for a range of compulsive behaviors.

Interventions

  • Drug Semaglutide
    All participants in the study will receive semaglutide (Wegovy).

Primary outcome measures

  • NIMH Trichotillomania Severity Scale [Time frame: From screening to 1 week after last dose of study drug]
Secondary outcome measures (2)
  • Clinical Global Impression-Improvement and Severity Scales [Time frame: From screening to 1 week after last dose of study drug]
  • Massachusetts General Hospital Hair Pulling Scale [Time frame: From screening to 1 week after last dose of study drug]

Eligibility criteria

Inclusion criteria

  • Men and women age 18-75;
  • Diagnosis of current trichotillomania based on DSM-5 criteria and confirmed using the clinician-administered MIDI (13);
  • Hair pulling daily with urges to pull as the trigger in >50% of the episodes of pulling;
  • Women of childbearing age are required to have a negative result on a beta-human chorionic gonadotropin pregnancy test;
  • Women of childbearing potential utilizing a medically accepted form of contraception defined as double barrier, oral contraceptive, injectable contraceptive, implantable contraceptive devices, and abstinence

Exclusion criteria

  • Infrequent pulling (i.e. less than daily) or automatic pulling (i.e. no urges to pull);
  • Unstable medical illness or clinically significant abnormalities on laboratory tests, EKG, or physical examination at screen as determined by the investigator;
  • History of seizures;
  • Myocardial infarction within 6 months;
  • Current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
  • A need for medication other than semaglutide with possible psychotropic effects or unfavorable interactions as determined by the investigator;
  • Clinically significant suicidality (defined by the Columbia Suicide-Severity Rating Scale);
  • Lifetime history of bipolar disorder type I or II, schizophrenia, or any psychotic disorder;
  • Current skin picking disorder;
  • Initiation of psychotherapy or behavior therapy within 3 months prior to study baseline;
  • Initiation of psychotropic medications within 3 months prior to study baseline (stable doses will be allowed);
  • Previous treatment with semaglutide;
  • Use of any weight loss medications;
  • Body mass index (BMI, calculated as weight in kilograms divided by height in meters squared) less than 23;
  • Past-year substance use disorder other than tobacco use disorder or mild cannabis use disorder;
  • Recent (30-day) use of illicit drugs except cannabis;
  • History of diabetes, and current medical or neurological illness precluding participation based on physician judgment;
  • Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia 2A or 2B;
  • History of pancreatitis.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07282769 · IRB25-1571

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗