Phase 2
Completed N=28
N-Acetyl Cysteine Plus Behavioral Therapy for Nicotine Dependent Pathological Gamblers
Gambling · Tobacco Use
Source: ClinicalTrials.gov NCT00967005 ↗
Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcomePrimary: Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Total Score — 23.5; 20.4 units on a scale
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.
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 Urges/Thoughts Subscale |
0.8; 3.6 | — |
| 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 Hamilton Depression Rating Scale Total Score |
2.8; 3.5 | — |
| PRIMARY Hamilton Anxiety Rating Scale Total Score |
5.0; 6.5 | — |
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
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. Informational only — not medical advice.