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An Open-Label Study of N-Acetyl Cysteine in Pathological Gambling

Primary Purpose

Pathological Gambling

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
N-Acetyl Cysteine
Sponsored by
University of Minnesota
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pathological Gambling focused on measuring Gambling, Gambler, Gamble, Pathological

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Minnesota

Outcomes

Primary Outcome Measures

PG-YBOCS

Secondary Outcome Measures

G-SAS

Full Information

First Posted
January 6, 2006
Last Updated
April 27, 2007
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT00273702
Brief Title
An Open-Label Study of N-Acetyl Cysteine in Pathological Gambling
Official Title
An Open-Label Study of N-Acetyl Cysteine in Pathological Gambling
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Minnesota

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pathological Gambling
Keywords
Gambling, Gambler, Gamble, Pathological

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
N-Acetyl Cysteine
Primary Outcome Measure Information:
Title
PG-YBOCS
Secondary Outcome Measure Information:
Title
G-SAS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon E Grant, MD, JD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States

12. IPD Sharing Statement

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An Open-Label Study of N-Acetyl Cysteine in Pathological Gambling

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