NCT00775229

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2008

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 20, 2008

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

March 17, 2014

Completed
Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

4.3 years

First QC Date

October 16, 2008

Results QC Date

October 9, 2013

Last Update Submit

February 21, 2023

Conditions

Trichotillomania

Keywords

hair pulling

Outcome Measures

Primary Outcomes (1)

  • National Institute of Mental Health Trichotillomania Symptom Severity Scale

    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.

    This is the final score, measured at week 8 (final visit).

Secondary Outcomes (2)

  • Massachusetts General Hospital Hairpulling Scale

    This is the final score, measured at week 8 (final visit).

  • Liver Function Tests

    Week 8 (last visit)

Study Arms (2)

1

ACTIVE COMPARATOR

Naltrexone

Drug: Naltrexone

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

NaltrexoneDRUG

pill, by mouth, 50mg-150mg/day for the duration of the study

Also known as: ReVia
1
PlaceboDRUG

pill, by mouth, daily

Also known as: also known as a 'sugar pill'
2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60615, United States

Location

Related Publications (2)

  • Hoffman J, Williams T, Rothbart R, Ipser JC, Fineberg N, Chamberlain SR, Stein DJ. Pharmacotherapy for trichotillomania. Cochrane Database Syst Rev. 2021 Sep 28;9(9):CD007662. doi: 10.1002/14651858.CD007662.pub3.

    PMID: 34582562DERIVED

  • Odlaug BL, Chamberlain SR, Harvanko AM, Grant JE. Age at onset in trichotillomania:clinical variables and neurocognitive performance. Prim Care Companion CNS Disord. 2012;14(4):PCC.12m01343. doi: 10.4088/PCC.12m01343. Epub 2012 Jul 19.

    PMID: 23251869DERIVED

MeSH Terms

Conditions

Trichotillomania

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Obsessive-Compulsive DisorderAnxiety DisordersMental DisordersDisruptive, Impulse Control, and Conduct Disorders

Intervention Hierarchy (Ancestors)

NaloxoneMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Results Point of Contact

Title
Dr. Jon Grant
Organization
University of Chicago
jongrant@uchicago.edu
773-834-1325

Study Officials

  • Jon E Grant, M.D.

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2008

First Posted

October 20, 2008

Study Start

August 1, 2008

Primary Completion

November 1, 2012

Study Completion

December 1, 2012

Last Updated

February 23, 2023

Results First Posted

March 17, 2014

Record last verified: 2023-02

Locations

US(1)