N-Acetylcysteine for Pediatric Trichotillomania

Yale University

Status and phase: Completed; Phase 2

Conditions: Hair Pulling; Trichotillomania

Treatments: Drug: Placebo; Drug: N-Acetylcysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT00993265

0906005337

NACPEDTTM

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 8 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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39 participants in 2 patient groups, including a placebo group

N-acetylcysteine (NAC)

Experimental group

Description:

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.

Treatment:

Drug: N-Acetylcysteine

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo