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Trial record 8 of 19 for:    "Trichotillomania"
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Naltrexone in the Treatment of Trichotillomania

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jon E. Grant, University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00775229
First received: October 16, 2008
Last updated: August 22, 2012
Last verified: August 2012
History of Changes
  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: Single Group 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:

U.S. FDA Resources

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • NIMH Trichotillomania Symptom Severity Scale [ Time Frame: From baseline assessment and used at each visit thereafter ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Massachusetts General Hospital Hairpulling Scale [ Time Frame: From baseline assessment and used at each visit thereafter ] [ Designated as safety issue: No ]
  • Liver function tests [ Time Frame: At baseline and at each visit where dosage of the medication is >50mg/day ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: August 2008
Estimated Study Completion Date: December 2012
Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00775229

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55454
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Jon E Grant, M.D. University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: Jon E. 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
Last Updated: August 22, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
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 May 19, 2013