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An Open-Label Study of N-Aceytl Cysteine in Pathological Gambling
This study is currently recruiting patients.
Verified by University of Minnesota January 2006
Sponsored by: University of Minnesota
Information provided by: University of Minnesota
ClinicalTrials.gov Identifier: NCT00273702
Purpose
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.
Condition Intervention Phase
Pathological Gambling
Drug: N-Acetyl Cysteine
Phase I
MedlinePlus related topics: Gambling
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Further study details as provided by University of Minnesota:
Primary Outcomes: PG-YBOCS
Secondary Outcomes: G-SAS
Expected Total Enrollment: 20
Study start: January 2006; Expected completion: December 2006
Last follow-up: July 2006; Data entry closure: August 2006
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.
Eligibility
Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible for Study: Both
Accepts Healthy Volunteers
Criteria
Inclusion Criteria:
* 1) men and women age 18-65; and 2) current DSM-IV PG
Exclusion Criteria:
* 1) unstable medical illness on 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) clinically significant suicidality; 6) lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder; 7) current or recent (past 3 months) DSM-IV substance abuse or dependence; 8) illegal substance within 2 weeks of study initiation; 9) initiation of psychotherapy or behavior therapy from a mental health professional within 3 months prior to study baseline; and 10) previous treatment with N-Acetyl Cysteine.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00273702
Jon E Grant, MD, JD 612-273-9736 grant045@umn.edu
Brian L Odlaug, BA 612-627-4363 odla0019@umn.edu
Minnesota
University of Minnesota, Minneapolis, Minnesota, 55454, United States; Recruiting
Jon E Grant, MD, JD 612-273-9736 grant045@umn.edu
Brian L Odlaug, BA 612-627-4363 odla0019@umn.edu
Jon E Grant, MD, JD, Principal Investigator
Study chairs or principal investigators
Jon E Grant, MD, JD, Principal Investigator, University of Minnesota
More Information
Study ID Numbers: 0511M77412
Last Updated: January 6, 2006
Record first received: January 6, 2006
ClinicalTrials.gov Identifier: NCT00273702
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2006-04-12
This study is currently recruiting patients.
Verified by University of Minnesota January 2006
Sponsored by: University of Minnesota
Information provided by: University of Minnesota
ClinicalTrials.gov Identifier: NCT00273702
Purpose
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.
Condition Intervention Phase
Pathological Gambling
Drug: N-Acetyl Cysteine
Phase I
MedlinePlus related topics: Gambling
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Further study details as provided by University of Minnesota:
Primary Outcomes: PG-YBOCS
Secondary Outcomes: G-SAS
Expected Total Enrollment: 20
Study start: January 2006; Expected completion: December 2006
Last follow-up: July 2006; Data entry closure: August 2006
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.
Eligibility
Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible for Study: Both
Accepts Healthy Volunteers
Criteria
Inclusion Criteria:
* 1) men and women age 18-65; and 2) current DSM-IV PG
Exclusion Criteria:
* 1) unstable medical illness on 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) clinically significant suicidality; 6) lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder; 7) current or recent (past 3 months) DSM-IV substance abuse or dependence; 8) illegal substance within 2 weeks of study initiation; 9) initiation of psychotherapy or behavior therapy from a mental health professional within 3 months prior to study baseline; and 10) previous treatment with N-Acetyl Cysteine.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00273702
Jon E Grant, MD, JD 612-273-9736 grant045@umn.edu
Brian L Odlaug, BA 612-627-4363 odla0019@umn.edu
Minnesota
University of Minnesota, Minneapolis, Minnesota, 55454, United States; Recruiting
Jon E Grant, MD, JD 612-273-9736 grant045@umn.edu
Brian L Odlaug, BA 612-627-4363 odla0019@umn.edu
Jon E Grant, MD, JD, Principal Investigator
Study chairs or principal investigators
Jon E Grant, MD, JD, Principal Investigator, University of Minnesota
More Information
Study ID Numbers: 0511M77412
Last Updated: January 6, 2006
Record first received: January 6, 2006
ClinicalTrials.gov Identifier: NCT00273702
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2006-04-12
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