An Open-Label Study of N-Acetyl Cysteine in Pathological Gambling
Condition: Pathological Gambling
MeSH terms: Gambling
Study type: Interventional
Phase: Phase 1

Summary: 
      After completing all screening evaluations, subjects will receive unblinded N-Acetyl Cysteine
      600 mg/day for 2 weeks. The dose will be raised to 1200 mg/day at visit 4 and to 1800 mg/day
      at visit 6 unless clinical improvement has been attained at a lower dose (clinical
      improvement will be assessed by the investigator with respect to gambling thoughts, urges and
      behavior). If it is clinically necessary to modify this schedule (e.g., because of side
      effects or an adequate response to a lower dose), the dose will be raised more slowly or the
      target dose will not be reached.

      Subjects will start no other psychotropic medications during the study but may continue on
      previously prescribed psychotropic medications if on a stable dose for 3 months prior to
      study entry. Psychotherapy of any form (including cognitive-behavioral therapy) will not be
      initiated during the study but subjects may continue with current psychotherapy if they have
      been undergoing therapy for at least three months prior to study entry.

      Subjects will be evaluated with the PG-YBOCS, G-SAS, CGI, HAM-D, HAM-A and the Sheehan
      Disability Inventory at screening and at each visit for the remainder of the study.
      Medication side effects will be evaluated at each study visit. A tablet count will be kept
      for each dose of medication taken.
    

Detailed description: 
      Before beginning N-Acetyl Cysteine, all subjects will receive a psychiatric, medical, and
      family history evaluation as well as the Structured Clinical Interview for DSM-IV (SCID-P)
      for Axis I disorders. At the screening visit, patients will also receive standard laboratory
      tests (including ß-HCG), and a physical examination.

      The following instruments will be completed at the screening visit and periodically
      throughout the study: 1) Yale-Brown Obsessive Compulsive Scale Modified for Pathological
      Gambling (PG-YBOCS), a reliable and valid semi-structured clinician-administered scale that
      assesses current severity of PG; 2) Gambling Symptom Assessment Scale (G-SAS), a reliable and
      valid self-report measure of gambling symptoms; 3) the 17-item Hamilton Rating Scale for
      Depression (HAM-D); 4) the 17-item Hamilton Rating Scale for Anxiety (HAM-A); 5) Clinical
      Global Impression scale; 6) the Sheehan Disability Inventory; and 7) the Quality of Life
      Inventory. Safety evaluations, including pulse and blood pressure, and assessment of side
      effects will be done at each visit.

      After completing all screening evaluations, subjects will receive unblinded N-Acetyl Cysteine
      600 mg/day for 2 weeks. The dose will be raised to 1200 mg/day at visit 4 and to 1800 mg/day
      at visit 6 unless clinical improvement has been attained at a lower dose (clinical
      improvement will be assessed by the investigator with respect to gambling thoughts, urges and
      behavior). If it is clinically necessary to modify this schedule (e.g., because of side
      effects or an adequate response to a lower dose), the dose will be raised more slowly or the
      target dose will not be reached.

      Subjects will start no other psychotropic medications during the study but may continue on
      previously prescribed psychotropic medications if on a stable dose for 3 months prior to
      study entry. Psychotherapy of any form (including cognitive-behavioral therapy) will not be
      initiated during the study but subjects may continue with current psychotherapy if they have
      been undergoing therapy for at least three months prior to study entry.

      Subjects will be evaluated with the PG-YBOCS, G-SAS, CGI, HAM-D, HAM-A and the Sheehan
      Disability Inventory at screening and at each visit for the remainder of the study.
      Medication side effects will be evaluated at each study visit. A tablet count will be kept
      for each dose of medication taken.
    

Intervention name(s): N-Acetyl Cysteine
Intervention type(s): Drug
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gambling; Gambler; Gamble; Pathological