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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
Marc Potenza, Yale University
ClinicalTrials.gov Identifier:
NCT00967005
First received: August 25, 2009
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Gambling
Tobacco Use Disorder
Drug: N Acetyl Cysteine
Other: Sugar Pill
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: N-Acetyl Cysteine Plus Behavioral Therapy for Nicotine Dependent Pathological Gamblers

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • The primary outcome will be at least 4 weeks of continuous abstinence from tobacco at the end of the 12-week treatment period. This will be confirmed by cotinine <10 ng/ml and CO <8 ppm. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Consistent with recent consensus on the assessment of PG severity, the main outcome measures will be money lost gambling per month. This will be assessed using the Gambling Timeline Followback (G-TLFB). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: September 2009
Estimated Study Completion Date: September 2014
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: N Acetyl Cysteine
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 PG symptoms in nicotine dependent pathological gamblers.
Drug: N Acetyl Cysteine
N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks
Other Name: N-acetylcysteine, Acetylcysteine, NAC
Placebo Comparator: Sugar Pill Other: Sugar Pill
placebo control

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 serious public health problem with detrimental effects on individuals and families, and with an estimated yearly cost to society of 5 billion dollars due to lost jobs, debt, bankruptcy, and incarcerations, is associated with elevated proportions of nicotine dependence (41% - 55%), and tobacco smoking in clinical samples of pathological gamblers has been associated with increased gambling severity and more frequent psychiatric problems (Smart & Ferris, 1996; Crockfod & El-Guebaly, 1998; Shaffer et al., 1999; Petry & Oncken, 2002; Potenza et al., 2004; Grant et al., 2005; Falk et al., 2006; Fagan et al., 2007). In addition, research suggests that continued nicotine use is associated with greater rates of relapse among pathological gamblers who received behavioral therapy. Despite increased awareness of the relationship between nicotine dependence and PG, and the possible effects of nicotine dependence on gambling severity, no previous research has focused on how assessment and treatment of nicotine dependence may aid in the successful treatment of PG or smoking cessation. Preliminary research suggests that behavioral therapy using imaginal desensitization and motivational interviewing (IDMI) has shown promise in reducing the symptoms of PG (Grant et al., in press). Despite the efficacy of treatments for PG and nicotine dependence, relapse is common among individuals with nicotine dependence and PG. Preclinical studies have suggested that levels of glutamate within the nucleus accumbens mediate reward-seeking behavior and may underlie relapse seen in addictions. N-acetyl cysteine, a dietary supplement, amino acid and cysteine pro-drug, appears to modulate glutamate within the nucleus accumbens and has shown benefit in reducing the reward-seeking behavior in individuals with cocaine dependence and in pathological gamblers (Baker et al., 2003; LaRowe et al., 2006; Grant et al., 2006). If successful in treating nicotine dependent pathological gamblers, N-acetyl cysteine may serve as a viable, low-cost, and easily available treatment option for nicotine dependent pathological gamblers who receive behavioral therapy.

We therefore propose to examine how a dietary supplement, N-acetyl cysteine, used in combination with behavioral therapy, will affect both the urge to smoke and gamble in nicotine dependent pathological gamblers and smoking and gambling behaviors. We therefore propose a randomized placebo-controlled trial of N-acetyl cysteine or placebo with 80 nicotine dependent pathological gamblers who will all receive brief standardized smoking cessation treatment (Ask, Advise, and Refer model) for nicotine cessation and 6 sessions of IDMI for PG. We hypothesize that N-acetyl cysteine plus behavioral therapy will result in greater reduction in both nicotine dependence and PG symptoms during the acute treatment phase and will enhance greater long-term abstinence. Our research will contribute to an improved understanding of the treatment of nicotine-dependent pathological gamblers as well as a greater understanding of the treatment of co-occurring addictions. If our intervention is successful, it will have the potential to set a new standard of care for a range of psychiatric disorders that co-occur with nicotine dependence.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00967005

Locations
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06519
United States, Minnesota
University of Minnesota School of Medicine
Minneapolis, Minnesota, United States, 55454
Sponsors and Collaborators
Yale University
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Marc N Potenza, MD, PhD Yale University
Principal Investigator: Jon E Grant, MD, JD, MPH University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided by Yale University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marc Potenza, Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT00967005     History of Changes
Other Study ID Numbers: 0908M70981, 1RC1DA028279-01
Study First Received: August 25, 2009
Last Updated: March 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Yale University:
N acetyl cysteine
Pathological gambling
Nicotine dependence

Additional relevant MeSH terms:
Gambling
Tobacco Use Disorder
Chemically-Induced Disorders
Impulse Control Disorders
Mental Disorders
Substance-Related Disorders
Acetylcysteine
N-monoacetylcystine
Nicotine
Anti-Infective Agents
Antidotes
Antioxidants
Antiviral Agents
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Expectorants
Free Radical Scavengers
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014