Status:
COMPLETED
N-Acetyl Cysteine Plus Behavioral Therapy for Nicotine Dependent Pathological Gamblers
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
University of Minnesota
Conditions:
Gambling
Tobacco Use Disorder
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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) symp...
Detailed Description
Among US adults, 12.8% report nicotine dependence, and nicotine dependence is highly associated with a variety of DSM-IV Axis I and II disorders (Grant BF et al., 2004). Pathological gambling (PG), a ...
Eligibility Criteria
Inclusion
- Male and female outpatients, age 18-75 years;
- Presence of current DSM-IV nicotine dependence and PG for at least 6 months duration;
- Stable psychotropic drug dose for a period of at least 3 months prior to study entry;
- Completion of complete blood count, urinalysis, liver function tests, thyroid function tests, and pregnancy test with no evidence of significant lab abnormalities;
- Signed informed consent
Exclusion
- Subjects who are currently receiving individual or group therapy specifically for nicotine dependence or PG symptoms;
- Currently receiving pharmacotherapies for either nicotine dependence or pathological gambling;
- Subjects who have started attending Gamblers Anonymous within the 3 months prior to study initiation;
- Subjects who have an unstable and significant medical illness;
- 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;
- Lifetime history of bipolar disorder type I or II, dementia, or psychotic disorder;
- Current (past 12 months) DSM-IV substance abuse or dependence (except nicotine dependence);
- Borderline or antisocial personality disorder based on the SCID-II;
- Positive urine drug screen at screening;
- Asthma (given possible worsening of asthma due to NAC);
- Cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent;
- Current pregnancy or lactation, or inadequate contraception in women of childbearing potential; and
- Previous treatment with NAC
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00967005
Start Date
September 1 2009
End Date
August 1 2014
Last Update
March 21 2023
Active Locations (2)
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1
Yale University School of Medicine
New Haven, Connecticut, United States, 06519
2
University of Minnesota School of Medicine
Minneapolis, Minnesota, United States, 55454