N-Acetylcysteine and Smoking Reduction

NCT ID: NCT00751257

Last Updated: 2017-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2007-10-31

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.

Conditions

Nicotine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

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

Group Type: EXPERIMENTAL

N-acetylcysteine

Intervention Type: DRUG

2400mg (1200mg b.i.d., 600mg capsules, p.o.)

2

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Identically appearing placebo capsules, packaged in an N-acetylcysteine "slurry" so that placebo has similar odor as active NAC capsules

Interventions

N-acetylcysteine

2400mg (1200mg b.i.d., 600mg capsules, p.o.)

Intervention Type: DRUG

Placebo

Identically appearing placebo capsules, packaged in an N-acetylcysteine "slurry" so that placebo has similar odor as active NAC capsules

Intervention Type: DRUG

Eligibility 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

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Medical Univeristy of South Carolina

Principal Investigators

Steven LaRowe, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

P50DA015369

Identifier Type: NIH

Identifier Source: secondary_id

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P50DA015369

Identifier Type: NIH

Identifier Source: org_study_id

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