N-Acetyl Cysteine Plus Behavioral Therapy for Nicotine Dependent Pathological Gamblers

0908M70981

The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and pathological gamblers (PG) symptoms in nicotine dependent pathological gamblers.

2009-09-01

2012-09-01

2014-08-01

Completed

Early phase I

28

Inclusion Criteria: 1. Male and female outpatients, age 18-75 years; 2. Presence of current DSM-IV nicotine dependence and PG for at least 6 months duration; 3. Stable psychotropic drug dose for a period of at least 3 months prior to study entry; 4. Completion of complete blood count, urinalysis, liver function tests, thyroid function tests, and pregnancy test with no evidence of significant lab abnormalities; 5. Signed informed consent Exclusion Criteria: 1. Subjects who are currently receiving individual or group therapy specifically for nicotine dependence or PG symptoms; 2. Currently receiving pharmacotherapies for either nicotine dependence or pathological gambling; 3. Subjects who have started attending Gamblers Anonymous within the 3 months prior to study initiation; 4. Subjects who have an unstable and significant medical illness; 5. Current clinically significant suicidality (score or 3 or 4 on item 3 of the Hamilton Depression Rating Scale) or any other disorder requiring immediate intervention; 6. Lifetime history of bipolar disorder type I or II, dementia, or psychotic disorder; 7. Current (past 12 months) DSM-IV substance abuse or dependence (except nicotine dependence); 8. Borderline or antisocial personality disorder based on the SCID-II; 9. Positive urine drug screen at screening; 10. Asthma (given possible worsening of asthma due to NAC); 11. Cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent; 12. Current pregnancy or lactation, or inadequate contraception in women of childbearing potential; and 13. Previous treatment with NAC

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2023-03-21