N-Acetyl Cysteine in Pathologic Skin Picking
Condition: Pathologic Skin Picking; Neurotic Excoriation; Psychogenic Excoriation; Dermatillomania
Intervention: N-Acetyl Cysteine; Placebo
Intervention description: 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); Matching placebo capsules taken in same amount of pills as the active medication.
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: N-Acetyl Cysteine; Picking; Impulse Control Disorder; Obsessive Compulsive Disorder

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.
    

Eligibility 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)