N-Acetyl Cysteine in Pathologic Skin Picking

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01063348
First received: February 3, 2010
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Pathologic Skin Picking
Neurotic Excoriation
Psychogenic Excoriation
Dermatillomania
Drug: N-Acetyl Cysteine
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 N-Acetyl Cysteine in Pathologic Skin Picking

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Yale Brown Obsessive Compulsive Scale (YBOCS) modified for PSP (NE-YBOCS) [ Time Frame: Once every three weeks during the 12 week study for each subject ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Skin Picking Self Assessment Scale (SP-SAS) [ Time Frame: Once every three weeks for the duration of the 12 week study for each subject ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: September 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: N-Acetyl Cysteine
N-Acetyl Cysteine - 600mg tablets by mouth (dosing 1200mg - 3000mg qd)
Drug: N-Acetyl Cysteine
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)
Other Name: NAC
Placebo Comparator: Placebo
Matching placebo taken daily
Drug: Placebo
Matching placebo capsules taken in same amount of pills as the active medication.
Other Name: Sugar pill

Detailed Description:

Pathologic skin picking involves repetitive, ritualistic, or impulsive picking of otherwise normal skin leading to tissue damage, personal distress, and impaired functioning. Although skin picking has been described in the medical literature for over one-hundred years, it remains a poorly understood psychiatric issue and often goes undiagnosed and untreated.

Picking behavior does not by itself suggest a psychiatric disorder. Pathology exists in the focus, duration and extent of the behavior, as well as the reasons for picking, associated emotions, and resulting problems. Patients with PSP report thoughts of picking or impulses to pick that are irresistible, intrusive and/or senseless. These thoughts, impulses, or behaviors also cause marked distress for patients and significantly interfere with other activities. Unlike normal picking behavior, the pathologic form of skin picking is recurrent and usually results in noticeable skin damage.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Unstable medical illness or clinically significant abnormalities on prestudy 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. Need for medication other than NAC with possible psychotropic effects or unfavorable interactions with NAC;
  6. Clinically significant suicidality (score or 3 or 4 on item 3 of the Hamilton Depression Rating Scale);
  7. Lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder;
  8. Current or recent (past 3 months) DSM-IV substance abuse or dependence;
  9. Illegal substance use within 2 weeks of study initiation;
  10. 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;
  11. Previous treatment with N-acetyl cysteine;
  12. 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;
  13. Asthma (given possible worsening of asthma due to NAC)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01063348

Contacts
Contact: Katherine L Derbyshire 773-834-3778 eleppink@uchicago.edu

Locations
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Eric Leppink    773-834-3778    eleppink@uchicago.edu   
Principal Investigator: Jon E Grant, MD, JD, MPH         
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Jon E Grant, MD, JD, MPH University of Chicago
  More Information

Publications:
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01063348     History of Changes
Other Study ID Numbers: 2010PSPNAC
Study First Received: February 3, 2010
Last Updated: July 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Chicago:
N-Acetyl Cysteine
Picking
Impulse Control Disorder
Obsessive Compulsive Disorder

Additional relevant MeSH terms:
Self-Injurious Behavior
Dermatitis
Skin Diseases
Behavioral Symptoms
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on July 09, 2014