- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00273702
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 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.
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55454
- University of Minnesota
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Men and women age 18-65
- Current DSM-IV PG
Exclusion Criteria:
- Unstable medical illness on physical examination
- History of seizures
- Myocardial infarction within 6 months
- Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
- Clinically significant suicidality
- Lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder
- Current or recent (past 3 months) DSM-IV substance abuse or dependence
- Illegal substance within 2 weeks of study initiation
- Initiation of psychotherapy or behavior therapy from a mental health professional within 3 months prior to study baseline
- Previous treatment with N-Acetyl Cysteine
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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PG-YBOCS
|
Secondary Outcome Measures
Outcome Measure |
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G-SAS
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Disruptive, Impulse Control, and Conduct Disorders
- Gambling
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Protective Agents
- Respiratory System Agents
- Antioxidants
- Antidotes
- Free Radical Scavengers
- Expectorants
- Acetylcysteine
- N-monoacetylcystine
Other Study ID Numbers
- 0511M77412
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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