Phase 2 N=28 Randomized Quadruple-blind Treatment

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

Gambling · Tobacco Use Disorder

Bottom Line

View on ClinicalTrials.gov: NCT00967005 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2017

Primary outcome: Primary: Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Total Score — 23.5; 20.4 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: N Acetyl Cysteine (Drug); Sugar Pill (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Chicago
Primary completion: Sep 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Total Score	1.0; 6.4	—
PRIMARY Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Total Score	1.0; 6.4	—
PRIMARY Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Total Score	1.0; 6.4	—
PRIMARY Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Total Score	1.0; 6.4	—
PRIMARY Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Urges/Thoughts Subscale	0.8; 3.6	—
PRIMARY Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Urges/Thoughts Subscale	0.8; 3.6	—
PRIMARY Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Urges/Thoughts Subscale	0.8; 3.6	—
PRIMARY Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Urges/Thoughts Subscale	0.8; 3.6	—
PRIMARY Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Behavior Subscale	0.2; 2.8	—
PRIMARY Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Behavior Subscale	0.2; 2.8	—
PRIMARY Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Behavior Subscale	0.2; 2.8	—
PRIMARY Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Behavior Subscale	0.2; 2.8	—
PRIMARY Fagerstrom Test for Nicotine Dependence Total Score	4.6; 5.3	—
PRIMARY Fagerstrom Test for Nicotine Dependence Total Score	4.6; 5.3	—
PRIMARY Fagerstrom Test for Nicotine Dependence Total Score	4.6; 5.3	—
PRIMARY Fagerstrom Test for Nicotine Dependence Total Score	4.6; 5.3	—
PRIMARY Hamilton Depression Rating Scale Total Score	2.8; 3.5	—
PRIMARY Hamilton Depression Rating Scale Total Score	2.8; 3.5	—
PRIMARY Hamilton Depression Rating Scale Total Score	2.8; 3.5	—
PRIMARY Hamilton Depression Rating Scale Total Score	2.8; 3.5	—
PRIMARY Hamilton Anxiety Rating Scale Total Score	5.0; 6.5	—
PRIMARY Hamilton Anxiety Rating Scale Total Score	5.0; 6.5	—
PRIMARY Hamilton Anxiety Rating Scale Total Score	5.0; 6.5	—
PRIMARY Hamilton Anxiety Rating Scale Total Score	5.0; 6.5	—

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.

Eligibility Criteria

Inclusion Criteria

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 Criteria

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

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Data sourced from ClinicalTrials.gov (NCT00967005). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.