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Naltrexone in the Treatment of Trichotillomania

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00775229
Recruitment Status : Completed
First Posted : October 20, 2008
Results First Posted : March 17, 2014
Last Update Posted : March 17, 2014
Sponsor:
Information provided by (Responsible Party):
Jon Grant, University of Minnesota

Tracking Information
First Submitted Date  ICMJE October 16, 2008
First Posted Date  ICMJE October 20, 2008
Results First Submitted Date  ICMJE October 9, 2013
Results First Posted Date  ICMJE March 17, 2014
Last Update Posted Date March 17, 2014
Study Start Date  ICMJE August 2008
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2014)
National Institute of Mental Health Trichotillomania Symptom Severity Scale [ Time Frame: This is the final score, measured at week 8 (final visit). ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 17, 2008)
NIMH Trichotillomania Symptom Severity Scale [ Time Frame: From baseline assessment and used at each visit thereafter ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2014)
  • Massachusetts General Hospital Hairpulling Scale [ Time Frame: This is the final score, measured at week 8 (final visit). ]
    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) ]
    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).
Original Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2008)
  • Massachusetts General Hospital Hairpulling Scale [ Time Frame: From baseline assessment and used at each visit thereafter ]
  • Liver function tests [ Time Frame: At baseline and at each visit where dosage of the medication is >50mg/day ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Naltrexone in the Treatment of Trichotillomania
Official Title  ICMJE A Double-blind, Placebo-controlled Study of Naltrexone in Trichotillomania
Brief Summary This is an 8-week, double-blind study of Natrexone in the treatment of trichotillomania
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Trichotillomania
Intervention  ICMJE
  • Drug: Naltrexone
    pill, by mouth, 50mg-150mg/day for the duration of the study
    Other Name: ReVia
  • Drug: Placebo
    pill, by mouth, daily
    Other Name: also known as a 'sugar pill'
Study Arms  ICMJE
  • Active Comparator: 1
    Naltrexone
    Intervention: Drug: Naltrexone
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 31, 2014)
51
Original Estimated Enrollment  ICMJE
 (submitted: October 17, 2008)
40
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00775229
Other Study ID Numbers  ICMJE 0806M36061
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Jon Grant, University of Minnesota
Original Responsible Party Jon E. Grant, University of Minnesota
Current Study Sponsor  ICMJE University of Chicago
Original Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jon E Grant, M.D. University of Minnesota
PRS Account University of Chicago
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP