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

NCT00273702 | Completed Phase 1

• 1 other identifier: 0511M77412
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Pathological Gambling

Keywords

Gambling; Gambler; Gamble; Pathological

Outcome Measures

Primary Outcomes (1)

• PG-YBOCS

Secondary Outcomes (1)

• G-SAS

Interventions

N-Acetyl Cysteine DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women age 18-65
• Current DSM-IV PG

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

MeSH Terms

Conditions

Gambling

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Risk-Taking; Behavior; Disruptive, Impulse Control, and Conduct Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Jon E Grant, MD, JD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 6, 2006
• First Posted: January 9, 2006
• Study Start: January 1, 2006
• Study Completion: September 1, 2006
• Last Updated: April 30, 2007

Record last verified: 2007-04

Locations

US (1)