NCT01063348

Brief Summary

The goal of the proposed study is to evaluate the comparative efficacy of N-acetyl cysteine to placebo in pathologic skin picking. Thirty subjects with pathologic skin picking will receive 12 weeks of double-blind treatment with N-acetyl cysteine or matching placebo. The hypothesis to be tested is that N-acetyl cysteine will be more effective than placebo in patients with pathologic skin picking. The proposed study will provide needed data on the treatment of an often disabling disorder that currently lacks a clearly effective treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2012

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

First Submitted

Initial submission to the registry

February 3, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 5, 2010

Completed
2.6 years until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

October 31, 2016

Completed
Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

2.8 years

First QC Date

February 3, 2010

Results QC Date

April 19, 2016

Last Update Submit

February 21, 2023

Conditions

Pathologic Skin PickingNeurotic ExcoriationPsychogenic ExcoriationDermatillomania

Keywords

N-Acetyl CysteinePickingImpulse Control DisorderObsessive Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

  • Yale Brown Obsessive Compulsive Scale (YBOCS) Modified for PSP (NE-YBOCS)

    The entire study for an individual subject will last 12 weeks. Every 3 weeks the subject will take the YBOCS for the duration of the 12 weeks. At each of these visits the outcome will be assessed. The minimum score is 0 and the maximum score is 40, with a higher score being more severe skin picking. There are two sub-scales: one for urges (ranges from 0 to 20) and one for behaviors (ranges from 0 to 20). The total of the scores of each of the sub-scales is the total YBOCS score. That is what will be reported.

    Once every three weeks during the 12 week study for each subject

Secondary Outcomes (1)

  • Skin Picking Self Assessment Scale (SP-SAS)

    Once every three weeks for the duration of the 12 week study for each subject

Study Arms (2)

N-Acetyl Cysteine

ACTIVE COMPARATOR

N-Acetyl Cysteine - 600mg tablets by mouth (dosing 1200mg - 3000mg qd)

Drug: N-Acetyl Cysteine

Placebo

PLACEBO COMPARATOR

Matching placebo taken daily

Drug: Placebo

Interventions

N-Acetyl CysteineDRUG

Week 0 (Visit 1) - Week 3 (V2): 1200mg/day (600mg po qam and 600mg po qpm) Week 3 (V2) - Week 6 (V3): 2400mg/day (1200mg po qam and 1200mg po qpm) Week 6 (V4) - Week 12 (V5): 3000mg/day (1200mg po qam and 1800mg po qpm)

Also known as: NAC
N-Acetyl Cysteine
PlaceboDRUG

Matching placebo capsules taken in same amount of pills as the active medication.

Also known as: Sugar pill
Placebo

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Men and women age 18-65;
  • Current diagnosis of pathologic skin picking as determined by criteria proposed by Arnold et al. (2001) for at least 6 months duration

You may not qualify if:

  • Unstable medical illness or clinically significant abnormalities on prestudy 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;
  • Need for medication other than NAC with possible psychotropic effects or unfavorable interactions with NAC;
  • Clinically significant suicidality (score or 3 or 4 on item 3 of the Hamilton Depression Rating Scale);
  • Lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder;
  • Current or recent (past 3 months) DSM-IV substance abuse or dependence;
  • Illegal substance use within 2 weeks of study initiation;
  • Initiation of pharmacotherapy, psychotherapy, or behavior therapy from a mental health professional within 3 months prior to study baseline for the treatment of pathologic skin picking;
  • 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;
  • Asthma (given possible worsening of asthma due to NAC)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (4)

  • Arnold LM, Auchenbach MB, McElroy SL. Psychogenic excoriation. Clinical features, proposed diagnostic criteria, epidemiology and approaches to treatment. CNS Drugs. 2001;15(5):351-9. doi: 10.2165/00023210-200115050-00002.

    PMID: 11475941BACKGROUND

  • Grant JE, Odlaug BL. Update on pathological skin picking. Curr Psychiatry Rep. 2009 Aug;11(4):283-8. doi: 10.1007/s11920-009-0041-x.

    PMID: 19635236BACKGROUND

  • Grant JE, Chesivoir E, Valle S, Ehsan D, Chamberlain SR. Double-Blind Placebo-Controlled Study of Memantine in Trichotillomania and Skin-Picking Disorder. Am J Psychiatry. 2023 May 1;180(5):348-356. doi: 10.1176/appi.ajp.20220737. Epub 2023 Feb 22.

    PMID: 36856701DERIVED

  • Grant JE, Chamberlain SR, Redden SA, Leppink EW, Odlaug BL, Kim SW. N-Acetylcysteine in the Treatment of Excoriation Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2016 May 1;73(5):490-6. doi: 10.1001/jamapsychiatry.2016.0060.

    PMID: 27007062DERIVED

MeSH Terms

Conditions

Excoriation DisorderDisruptive, Impulse Control, and Conduct DisordersObsessive-Compulsive Disorder

Interventions

AcetylcysteineSugars

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehaviorAnxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

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

Study Officials

  • Jon E Grant, MD, JD, MPH

    University of Chicago

    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

February 3, 2010

First Posted

February 5, 2010

Study Start

September 1, 2012

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

February 23, 2023

Results First Posted

October 31, 2016

Record last verified: 2023-02

Locations

US(1)