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NCT00273702 · ClinicalTrials.gov registry record · Phase 1
An Open-Label Study of N-Acetyl Cysteine in Pathological Gambling
A Phase 1 study, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT00273702 is a Phase 1 study that has completed, run by University of Minnesota. The registered enrollment target is 36 participants.
The verdict
NCT00273702, a Phase 1 study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study 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.
Interventions
- DRUG N-Acetyl Cysteine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2006-01 |
| Est. Completion | 2006-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00273702
The ClinicalTrials.gov registry entry for NCT00273702 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which N-Acetyl Cysteine is the first listed.
NCT00273702 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00273702 about?
NCT00273702 is a clinical study titled "An Open-Label Study of N-Acetyl Cysteine in Pathological Gambling". 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 b...
What is the current status of trial NCT00273702?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2006-01. Estimated completion is 2006-09.
What interventions are being tested in trial NCT00273702?
The interventions under investigation include: N-Acetyl Cysteine (DRUG).
Who is sponsoring clinical trial NCT00273702?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
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