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

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago; Yale University
• Collaborators: National Institute on Drug Abuse (NIDA); University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Treatments: Acetylcysteine; N-monoacetylcystine; Nicotine

Criteria

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