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N-Acetylcysteine and Smoking Reduction

Primary Purpose

Nicotine Dependence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
N-acetylcysteine
Placebo
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nicotine Dependence focused on measuring Nicotine, N-acetylcysteine, smoking reduction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

2400mg N-acetylcysteine (1200mg b.i.d.) for 4 consecutive weeks

Identically appearing placebo pills, packaged in an N-acetylcysteine "slurry" so that placebo will retain smell similar to active NAC capsules

Outcomes

Primary Outcome Measures

Carbon Monoxide Levels
Smoking Level
Craving Levels (Questionnaire for Smoking Urges -- Brief)
Minnesota Nicotine Withdrawal Scale (MNWS)

Secondary Outcome Measures

Smoking Level

Full Information

First Posted
September 10, 2008
Last Updated
March 22, 2017
Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00751257
Brief Title
N-Acetylcysteine and Smoking Reduction
Official Title
A Randomized Controlled Trial of Oral N-acetylcysteine for Smoking Reduction: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence
Keywords
Nicotine, N-acetylcysteine, smoking reduction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
2400mg N-acetylcysteine (1200mg b.i.d.) for 4 consecutive weeks
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Identically appearing placebo pills, packaged in an N-acetylcysteine "slurry" so that placebo will retain smell similar to active NAC capsules
Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine
Intervention Description
2400mg (1200mg b.i.d., 600mg capsules, p.o.)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Identically appearing placebo capsules, packaged in an N-acetylcysteine "slurry" so that placebo has similar odor as active NAC capsules
Primary Outcome Measure Information:
Title
Carbon Monoxide Levels
Time Frame
Weekly
Title
Smoking Level
Time Frame
Weekly
Title
Craving Levels (Questionnaire for Smoking Urges -- Brief)
Time Frame
Weekly
Title
Minnesota Nicotine Withdrawal Scale (MNWS)
Time Frame
Weekly
Secondary Outcome Measure Information:
Title
Smoking Level
Time Frame
Daily

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven LaRowe, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

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N-Acetylcysteine and Smoking Reduction

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