An Open-Label Study of N-Acetyl Cysteine in Pathological Gambling
Status:
Completed
Trial end date:
2006-09-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
University of Minnesota University of Minnesota - Clinical and Translational Science Institute