Naltrexone in the Treatment of Trichotillomania

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jon Grant, University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00775229
First received: October 16, 2008
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Trichotillomania
Drug: Naltrexone
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled Study of Naltrexone in Trichotillomania

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • National Institute of Mental Health Trichotillomania Symptom Severity Scale [ Time Frame: This is the final score, measured at week 8 (final visit). ] [ Designated as safety issue: No ]
    Ranges from 0-20 with 20 being the most severe. The lower the total score, the lower the severity level. This scale is given and measured once every 2 weeks for a total of 8 weeks. The final total score is reported here.


Secondary Outcome Measures:
  • Massachusetts General Hospital Hairpulling Scale [ Time Frame: This is the final score, measured at week 8 (final visit). ] [ Designated as safety issue: No ]
    Ranges from 0-28 with 28 being the most severe. The lower the total score, the lower the severity level. This scale is given and measured once every 2 weeks for a total of 8 weeks. The final total score is reported here.

  • Liver Function Tests [ Time Frame: Week 8 (last visit) ] [ Designated as safety issue: Yes ]
    Participants were administered a general test of liver functioning to asses safety over the course of the study. Data represent the percentage of participates with Liver Function Test values falling outside of the range considered safe/typical for liver functioning at any of the assessed time points. It was performed at baseline and at each visit where dosage of the medication is >50mg/day (week 2-week 8).


Enrollment: 51
Study Start Date: August 2008
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Naltrexone
Drug: Naltrexone
pill, by mouth, 50mg-150mg/day for the duration of the study
Other Name: ReVia
Placebo Comparator: 2
Placebo
Drug: Placebo
pill, by mouth, daily
Other Name: also known as a 'sugar pill'

Detailed Description:

The goal of the proposed study is to evaluate the efficacy of Naltrexone in trichotillomania. Forty subjects with DSM-IV trichotillomania will receive 8 weeks of double-blind Naltrexone or placebo. The hypothesis to be tested is that Naltrexone will be effective and well tolerated in patients with trichotillomania compared to placebo. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. unstable medical illness or clinically significant abnormalities on pre-study laboratory tests or physical examination;
  2. history of seizures;
  3. myocardial infarction within 6 months;
  4. current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
  5. clinically significant suicidality;
  6. current or recent (past 3 months) DSM-IV substance abuse or dependence;
  7. illegal substance within 2 weeks of study initiation;
  8. initiation of psychotherapy or behavior therapy from a mental health professional for the treatment of trichotillomania within 3 months prior to study baseline;
  9. initiation of a psychotropic medication within 2 months prior to study inclusion;
  10. previous treatment with naltrexone; and
  11. 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;
  12. lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder;
  13. current use of opiates.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00775229

Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60615
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Jon E Grant, M.D. University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: Jon Grant, Professor of Psychiatry, University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00775229     History of Changes
Other Study ID Numbers: 0806M36061
Study First Received: October 16, 2008
Results First Received: October 9, 2013
Last Updated: January 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
hair pulling

Additional relevant MeSH terms:
Trichotillomania
Impulse Control Disorders
Mental Disorders
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 14, 2014