Phase 2 N=51 Randomized Triple-blind Treatment

Naltrexone in the Treatment of Trichotillomania

Trichotillomania

Bottom Line

View on ClinicalTrials.gov: NCT00775229 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2014

Primary outcome: Primary: National Institute of Mental Health Trichotillomania Symptom Severity Scale — 7.94; 8.73 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Naltrexone (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Chicago
Primary completion: Nov 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY National Institute of Mental Health Trichotillomania Symptom Severity Scale	7.94; 8.73	—
SECONDARY Massachusetts General Hospital Hairpulling Scale	12.21; 13.35	—
SECONDARY Liver Function Tests	0; 0	—

Summary

This is an 8-week, double-blind study of Natrexone in the treatment of trichotillomania

Eligibility Criteria

Inclusion Criteria

men and women age 18-75;
current DSM-IV trichotillomania;
hair-pulling primarily due to urges/cravings; and 4) pulling is reported as pleasurable the majority of time.

Exclusion Criteria

unstable medical illness or clinically significant abnormalities on pre-study laboratory tests or physical examination;
history of seizures;
myocardial infarction within 6 months;
current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
clinically significant suicidality;
current or recent (past 3 months) DSM-IV substance abuse or dependence;
illegal substance within 2 weeks of study initiation;
initiation of psychotherapy or behavior therapy from a mental health professional for the treatment of trichotillomania within 3 months prior to study baseline;
initiation of a psychotropic medication within 2 months prior to study inclusion;
previous treatment with naltrexone; and
treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline;
lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder;
current use of opiates.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00775229). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.