N-Acetylcysteine and Smoking Reduction

Nicotine Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00751257
• Other study ID #: P50DA015369
• Secondary ID: P50DA015369
• Status: Completed
• Phase: Phase 2
• First received: September 10, 2008
• Last updated: March 22, 2017
• Start date: December 2006
• Est. completion date: October 2007

Study information

• Verified date: September 2008
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Use Disorder

Intervention

Drug:
• N-acetylcysteine
2400mg (1200mg b.i.d., 600mg capsules, p.o.)
• Placebo
Identically appearing placebo capsules, packaged in an N-acetylcysteine "slurry" so that placebo has similar odor as active NAC capsules

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Carbon Monoxide Levels		Weekly
Primary	Smoking Level		Weekly
Primary	Craving Levels (Questionnaire for Smoking Urges -- Brief)		Weekly
Primary	Minnesota Nicotine Withdrawal Scale (MNWS)		Weekly
Secondary	Smoking Level		Daily