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Sponsored by: |
National Institute on Drug Abuse (NIDA) |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00751257 |
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 |
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Nicotine Dependence |
Drug: N-acetylcysteine Drug: Placebo |
Phase II |
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 |
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 |
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1: Experimental
2400mg N-acetylcysteine (1200mg b.i.d.) for 4 consecutive weeks
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Drug: N-acetylcysteine
2400mg (1200mg b.i.d., 600mg capsules, p.o.)
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2: Placebo Comparator
Identically appearing placebo pills, packaged in an N-acetylcysteine "slurry" so that placebo will retain smell similar to active NAC capsules
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Drug: Placebo
Identically appearing placebo capsules, packaged in an N-acetylcysteine "slurry" so that placebo has similar odor as active NAC capsules
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Nicotine N-acetylcysteine smoking reduction |
Nicotine polacrilex Smoking Antioxidants Nicotine Mental Disorders Expectorants |
Tobacco Use Disorder Substance-Related Disorders Acetylcysteine Disorders of Environmental Origin Antiviral Agents N-monoacetylcystine |
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 |