NCT00354770

Brief Summary

This is a 12-week, double-blind study of N-Acetyl Cysteine in the treatment of trichotillomania

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2006

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

July 1, 2006

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
5.4 years until next milestone

Results Posted

Study results publicly available

January 15, 2014

Completed
Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

2.2 years

First QC Date

July 18, 2006

Results QC Date

March 1, 2012

Last Update Submit

February 21, 2023

Conditions

Trichotillomania

Keywords

TrichotillomaniaHair-pulling

Outcome Measures

Primary Outcomes (1)

  • Massachusetts General Hospital Hairpulling Scale

    There is no minimum or maximum score to quantify 'good' or 'poor' improvement based on this scale. The total score can range from 0-28 with zero being no problems to 28 being the most severe score one can receive.A total of 6 assessments were made, however only the final score (the score at the final visit after 12 weeks) was reported here to show the final outcome measure that was used in the final report of possible improvement and what was reported for final publication of data.

    Baseline and final visit after 12 weeks

Study Arms (2)

N-Acetyl Cysteine

ACTIVE COMPARATOR

N-Acetyl Cysteine

Drug: N-Acetyl Cysteine

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

PlaceboDRUG

daily

2
N-Acetyl CysteineDRUG

600mg capsules in varying doses for 12 weeks.

Also known as: NAC
N-Acetyl Cysteine

Eligibility Criteria

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

You may qualify if:

  • men and women age 18-65;
  • current DSM-IV trichotillomania

You may not qualify if:

  • unstable medical illness;
  • history of seizures;
  • myocardial infarction within 6 months;
  • current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
  • any thoughts of suicide;
  • lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder;
  • previous treatment with N-Acetyl Cysteine;
  • 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;
  • \) diagnosis of asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Related Publications (3)

  • 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

  • Grant JE, Odlaug BL, Kim SW. N-acetylcysteine, a glutamate modulator, in the treatment of trichotillomania: a double-blind, placebo-controlled study. Arch Gen Psychiatry. 2009 Jul;66(7):756-63. doi: 10.1001/archgenpsychiatry.2009.60.

    PMID: 19581567DERIVED

MeSH Terms

Conditions

Trichotillomania

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Results Point of Contact

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

Study Officials

  • Jon E Grant, MD, JD

    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
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2006

First Posted

July 20, 2006

Study Start

July 1, 2006

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

February 23, 2023

Results First Posted

January 15, 2014

Record last verified: 2023-02

Locations

US(1)