Tobacco Use Disorder Clinical Trial
Official title:
N-Acetyl Cysteine Plus Behavioral Therapy for Nicotine Dependent Pathological Gamblers
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT02432066 -
Effects of GTS-21 on Smoking Behavior and Neurocognitive Functions
|
Phase 2 | |
| Completed |
NCT03960138 -
Examining the Effects of Neural Stimulation on Inhibitory Control and Cigarette Smoking
|
N/A | |
| Recruiting |
NCT05030272 -
Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings
|
N/A | |
| Completed |
NCT04646668 -
Comparative Abuse Liability Among African American and White Smokers
|
N/A | |
| Completed |
NCT02560324 -
Effect of Ramelteon on Smoking Abstinence
|
Phase 2 | |
| Completed |
NCT02347605 -
Medicinal Nicotine for Preventing Cue Induced Craving
|
N/A | |
| Completed |
NCT01442753 -
Family-Skills Training to Prevent Tobacco and Other Substance Use in Latino Youth
|
N/A | |
| Terminated |
NCT01800500 -
Interest in Smokeless Tobacco Product as a Substitution for Cigarettes in Current Smokers
|
N/A | |
| Completed |
NCT01625767 -
Tobacco Approach Avoidance Training for Adolescent Smokers-1
|
Phase 2 | |
| Completed |
NCT01570595 -
Positively Smoke Free on the Web (PSFW) for Smokers Living With HIV
|
Phase 1/Phase 2 | |
| Completed |
NCT01428310 -
Study to Evaluate the Safety and Efficacy of Dietary Supplement Anatabloc in Reducing Daily Smokers' Urge to Smoke
|
Phase 1 | |
| Active, not recruiting |
NCT01539525 -
Screening to Augment Referral to Treatment- Project START
|
Phase 2 | |
| Completed |
NCT01337817 -
A Pilot Study to Evaluate the Efficacy and Safety of Ariva® Silver Wintergreen in Healthy Smokers
|
Phase 1 | |
| Active, not recruiting |
NCT00751660 -
Screening Methods in Finding Lung Cancer Early in Current or Former Smokers
|
N/A | |
| Completed |
NCT00790569 -
Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking
|
N/A | |
| Completed |
NCT00664261 -
Clinical Effort Against Secondhand Smoke (CEASE) Program or Standard Care in Helping Parents Stop Smoking
|
N/A | |
| Completed |
NCT01213524 -
Nicotine and Sensorimotor Replacement for Smoking in Smokers With Schizophrenia
|
Phase 2 | |
| Completed |
NCT00158145 -
Assessing the Variability Over Time of Tobacco Carcinogen Biomarkers in Smokers - 2
|
Phase 2 | |
| Completed |
NCT00158158 -
Effectiveness of Reducing Smoking in Facilitating Smoking Cessation in Adolescents - 2
|
Phase 2/Phase 3 | |
| Completed |
NCT00134927 -
A Survey on Consumer Use of Over-the-Counter (OTC) Nicotine Patches
|
N/A |