N-Acetylcysteine and Smoking Reduction - Full Text View

Purpose

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.

Condition	Intervention	Phase
Nicotine Dependence	Drug: N-acetylcysteine Drug: Placebo	Phase II

MedlinePlus related topics:

Smoking

ChemIDplus related topics:

Acetylcysteine Nicotine polacrilex Nicotine tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment

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

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Carbon Monoxide Levels [ Time Frame: Weekly ] [ Designated as safety issue: No ]
Smoking Level [ Time Frame: Weekly ] [ Designated as safety issue: No ]
Craving Levels (Questionnaire for Smoking Urges -- Brief) [ Time Frame: Weekly ] [ Designated as safety issue: No ]
Minnesota Nicotine Withdrawal Scale (MNWS) [ Time Frame: Weekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Smoking Level [ Time Frame: Daily ] [ Designated as safety issue: No ]

Enrollment:	33
Study Start Date:	December 2006
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 2400mg N-acetylcysteine (1200mg b.i.d.) for 4 consecutive weeks	Drug: N-acetylcysteine 2400mg (1200mg b.i.d., 600mg capsules, p.o.)
2: Placebo Comparator Identically appearing placebo pills, packaged in an N-acetylcysteine "slurry" so that placebo will retain smell similar to active NAC capsules	Drug: Placebo Identically appearing placebo capsules, packaged in an N-acetylcysteine "slurry" so that placebo has similar odor as active NAC capsules

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00751257

Locations


United States, South Carolina
	Medical University of South Carolina
	Charleston, South Carolina, United States, 29425

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

More Information

Responsible Party:	Medical Univeristy of South Carolina ( Steven D. LaRowe, Ph.D.; Research Assistant Professor, Principal Investigator )
Study ID Numbers:	P50 DA015369
First Received:	September 10, 2008
Last Updated:	September 10, 2008
ClinicalTrials.gov Identifier:	NCT00751257
Health Authority:	United States: Food and Drug Administration; United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):

Nicotine

N-acetylcysteine

smoking reduction

Study placed in the following topic categories:

Nicotine polacrilex

Smoking

Nicotine

Mental Disorders

Tobacco Use Disorder

Substance-Related Disorders

Acetylcysteine

Disorders of Environmental Origin

N-monoacetylcystine

Additional relevant MeSH terms:

Anti-Infective Agents

Respiratory System Agents

Antioxidants

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Expectorants

Physiological Effects of Drugs

Free Radical Scavengers

Protective Agents

Antiviral Agents

Pharmacologic Actions

Antidotes

ClinicalTrials.gov processed this record on October 06, 2008

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00751257