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N-Acetylcysteine and Smoking Reduction
This study has been completed.
First Received: September 10, 2008   No Changes Posted
Sponsored by: National Institute on Drug Abuse (NIDA)
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00751257
  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
Drug Information available for: Acetylcysteine
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:

  1. Be smokers motivated to reduce their cigarette usage but not seeking treatment to quit smoking at the time of screening.
  2. Be Able to give written informed consent after being presented with an IRB-approved informed consent document
  3. Be male or female of any race, between eighteen and sixty five years of age.
  4. Be in stable physical and mental health as judged by interview
  5. Be smoking 10 or more cigarettes per day for one or more years
  6. Have an expired CO reading of ≥10 parts/million prior to beginning study
  7. 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.
  8. Be able to comply with protocol requirements and be likely to complete all study treatments.
  9. Live within 50 miles of the study site

Exclusion Criteria:

  1. 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.
  2. 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.
  3. Have a history of adverse reaction/hypersensitivity to N-acetylcysteine.
  4. 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.
  5. Used carbamazepine or Nitroglycerin within the last 14 days or any other medication felt to be hazardous if taken with NAC
  6. Have a current or past history of asthma and/or the occasional or daily use of Albuterol or other beta-agonist inhalers.
  7. Females pregnant or breast-feeding
  8. Have any medical history or condition considered by the investigator(s) to place the subjects at increased risk.
  9. Not fail to actively meet the inclusion criteria at the time of screening.
  10. Have a history of childhood or adult seizures of any cause.
  11. 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
  More Information

No publications provided

Responsible Party: Medical Univeristy of South Carolina ( Steven D. LaRowe, Ph.D.; Research Assistant Professor, Principal Investigator )
Study ID Numbers: P50 DA015369
Study First Received: September 10, 2008
Last Updated: September 10, 2008
ClinicalTrials.gov Identifier: NCT00751257     History of Changes
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
Antioxidants
Nicotine
Mental Disorders
Expectorants
Tobacco Use Disorder
Substance-Related Disorders
Acetylcysteine
Disorders of Environmental Origin
Antiviral Agents
N-monoacetylcystine

Additional relevant MeSH terms:
Anti-Infective Agents
Respiratory System Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Tobacco Use Disorder
Physiological Effects of Drugs
Disorders of Environmental Origin
Protective Agents
Antiviral Agents
Pharmacologic Actions
Mental Disorders
Expectorants
Therapeutic Uses
Free Radical Scavengers
Substance-Related Disorders
Acetylcysteine
N-monoacetylcystine
Antidotes

ClinicalTrials.gov processed this record on May 07, 2009