N-Acetylcysteine and Smoking Reduction

Study Overview
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Brief Summary
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N-acetylcysteine is an inexpensive agent with a benign side effect profile with preliminary studies in humans suggesting efficacy for the treatment of cocaine dependence. N-acetylcysteine has been used in clinical medicine for nearly three decades to treat chronic lung conditions, acetaminophen overdose, and experimentally to treat cocaine dependence. It is generally safe and well tolerated. The present pilot study seeks to explore safety and tolerability, ad lib smoking, visual cue reactivity, and smoking reduction rates in a group of nontreatment seeking, nicotine dependence smokers who are willing to undergo a brief trial with oral N-acetylcysteine 1200 mg twice daily.

Official Title
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A Randomized Controlled Trial of Oral N-acetylcysteine for Smoking Reduction: a Pilot Study

Conditions
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Nicotine Dependence

Intervention / Treatment
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* Drug: N-acetylcysteine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be smokers motivated to reduce their cigarette usage but not seeking treatment to quit smoking at the time of screening. Be Able to give written informed consent after being presented with an IRB-approved informed consent document Be male or female of any race, between eighteen and sixty five years of age. Be in stable physical and mental health as judged by interview Be smoking 10 or more cigarettes per day for one or more years Have an expired CO reading of ≥10 parts/million prior to beginning study Test non-pregnant and use adequate birth control (female only). All female subjects will have a urine pregnancy test performed prior to the first dose of study medication. Be able to comply with protocol requirements and be likely to complete all study treatments. Live within 50 miles of the study site Exclusion Criteria: Have current dependence, defined by DSM IV criteria, on any psychoactive substance other than nicotine, alcohol, or marijuana or physiological dependence on alcohol requiring medical detoxification. Have a history of significant hepatic, renal, endocrine, cardiac (i.e., arrhythmia requiring medication, angina pectoris, myocardial infarction,), stroke, seizure, neurological, non-drug-related psychiatric, gastrointestinal, pulmonary, hematologic or metabolic disorders. Have a history of adverse reaction/hypersensitivity to N-acetylcysteine. Have any significant active medical or psychiatric illness (e.g. schizophrenia, suicidal/homicidal ideation within the past 30 days) which might inhibit their ability to complete the study or might be complicated by administration of NAC. Used carbamazepine or Nitroglycerin within the last 14 days or any other medication felt to be hazardous if taken with NAC Have a current or past history of asthma and/or the occasional or daily use of Albuterol or other beta-agonist inhalers. Females pregnant or breast-feeding Have any medical history or condition considered by the investigator(s) to place the subjects at increased risk. Not fail to actively meet the inclusion criteria at the time of screening. Have a history of childhood or adult seizures of any cause. Be currently taking any medications (i.e., beta-blockers, stimulant medications) that might affect heart rate or skin conductance

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>2400mg N-acetylcysteine (1200mg b.i.d.) for 4 consecutive weeks | Drug: N-acetylcysteine<br>* 2400mg (1200mg b.i.d., 600mg capsules, p.o.)<br>|
| Placebo Comparator: 2<br>Identically appearing placebo pills, packaged in an N-acetylcysteine slurry so that placebo will retain smell similar to active NAC capsules | Drug: Placebo<br>* Identically appearing placebo capsules, packaged in an N-acetylcysteine slurry so that placebo has similar odor as active NAC capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carbon Monoxide Levels |  | Weekly | 
| Smoking Level |  | Weekly | 
| Craving Levels (Questionnaire for Smoking Urges -- Brief) |  | Weekly | 
| Minnesota Nicotine Withdrawal Scale (MNWS) |  | Weekly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking Level |  | Daily | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nicotine, N-acetylcysteine, smoking reduction