N-Acetylcysteine for Pediatric Trichotillomania

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2014-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Trichotillomania (hair pulling) has an estimated lifetime prevalence of 1-3%. Children with trichotillomania can experience significant impairment due to peer teasing, avoidance of activities (such as swimming and socializing), difficulty concentrating on school work and medical complications due to pulling behaviors. Despite the fact that trichotillomania has a childhood onset, no randomized, controlled trials have been completed in childhood trichotillomania.

Research in adults with trichotillomania has demonstrated that most commonly currently prescribed treatment for trichotillomania, (pharmacotherapy with selective serotonin reuptake inhibitors) is ineffective in treating this condition. By contrast, randomized controlled trials in adults have suggested the efficacy of N-acetylcysteine as well as behavioral treatments such as Habit Reversal Therapy.

The goal of this trial is to determine the efficacy of N-Acetylcysteine for pediatric trichotillomania. N-Acetylcysteine is a glutamate modulating agent, with a fairly benign side-effect profile.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

N-acetylcysteine (NAC) for Children With Tourette Syndrome

NCT01172288

Tourettes Syndrome Tic

COMPLETED PHASE2

Antioxidant Therapy With N-acetylcysteine for Learning and Motor Behavior in Children With Neurofibromatosis Type 1

NCT04481035

Neurofibromatosis 1

COMPLETED PHASE2

Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure

NCT01149538

Fetal Alcohol Spectrum Disorders Fetal Alcohol Syndrome Partial Fetal Alcohol Syndrome +2 more

COMPLETED PHASE1/PHASE2

A Pharmacokinetic (PK) Study of NatrOVA Topical Creme (1%) in Pediatric Subjects 6 to 24 Months of Age

NCT00410709

Pediculosis Capitis (Head Lice)

COMPLETED PHASE1

Baclofen for Children With Rumination Syndrome

NCT05975684

Rumination Syndrome

RECRUITING PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Trichotillomania Hair Pulling

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

N-acetylcysteine (NAC)

Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.

Group Type EXPERIMENTAL

N-Acetylcysteine

Intervention Type DRUG

2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks

Placebo

Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

N-Acetylcysteine

2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks

Intervention Type DRUG

Placebo

placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Children aged 8-17 years.
* Primary DSM-IV diagnosis of trichotillomania or chronic hair pulling.
* Duration of trichotillomania greater than 6 months.

Exclusion Criteria

* Comorbid bipolar disorder, psychotic disorder, substance use disorder, developmental disorder or mental retardation (IQ\<70).
* Recent change (less than 4 weeks) in medications that have potential effects on TTM severity (such as SSRIs, CMI, naltrexone, lithium, psychostimulants, anxiolytics, or antipsychotics). Medication change is defined to include either dose changes or medication discontinuation.
* Asthma requiring medication use within the last 6 months.
* Known hypersensitivity or previous anaphylactoid reaction to acetylcysteine or any components in its preparation
* Current use (within last week) of psychostimulant medications.
* Positive pregnancy test or drug screening test

Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No