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Trial record 5 of 675 for:    "tobacco use disorder"

N-acetylcysteine for Tobacco Use Disorder

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ClinicalTrials.gov Identifier: NCT02737358
Recruitment Status : Recruiting
First Posted : April 13, 2016
Last Update Posted : January 31, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Erin McClure, Medical University of South Carolina

Brief Summary:
The purpose of this study is to assess the effects of administering N-Acetylcysteine (NAC) to assist in initial cessation and/or relapse prevention in adult cigarette smokers.

Condition or disease Intervention/treatment Phase
Nicotine Dependence Smoking Drug: N-acetylcysteine (NAC) Other: Placebo Phase 2

Detailed Description:
The aim of this study is to assess the effects of N-acetylcysteine (NAC) on initial cessation and relapse prevention in adult cigarette smokers. Specifically, this study has the following aims: Aim 1) Examine the efficacy of NAC, compared to placebo, in helping smokers achieve three days of continuous abstinence; Aim 2) Among those who maintain initial 3-day abstinence, examine the time to relapse over the 8-week intervention between NAC and placebo groups; Aim 3) Assess 7-day point prevalence abstinence at the 8-week end-of-treatment study visit in order to obtain effect sizes and estimates of variability to power a randomized clinical trial.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluating N-acetylcysteine as a Pharmacotherapy for Tobacco Use Disorder
Study Start Date : August 30, 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Placebo Comparator: Placebo
Matched placebo will be given to half of the study participants.
Other: Placebo
Matched placebo (2 capsules taken in the morning and evening) will be taken by study participants for eight weeks. All participants will receive brief smoking cessation counseling and support.

Active Comparator: N-Acetylcysteine (NAC)
NAC will be given to half of the study participants. The dose of NAC will be 2400 mg per day (1200 mg taken twice per day as two 600 mg capsules)
Drug: N-acetylcysteine (NAC)
NAC or matched placebo will be given to study participants for 8 weeks.
Other Name: NAC




Primary Outcome Measures :
  1. Biochemically-verified abstinence from smoking on Days 1-3 of the protocol. [ Time Frame: Days 1-3 of the study protocol ]
    Abstinence will be measured through biochemical verification via breath carbon monoxide. Abstinence is defined as a 75% reduction in carbon monoxide values (parts per million) from smoking baseline levels.


Secondary Outcome Measures :
  1. Days to relapse to smoking [ Time Frame: Days 4-56 of the study protocol ]
    Relapse to smoking will be measured through carbon monoxide-verified relapse at weekly study visits. Relapse (return to smoking) will be defined as carbon monoxide values (in parts per million) that do not meet abstinence criteria (i.e., 75% reduction from baseline smoking levels).

  2. 7-day point prevalence abstinence at the 8-week end-of-treatment visit [ Time Frame: Days 49-56 ]
    Seven day point prevalence abstinence will be measured through biochemical verification via breath carbon monoxide and urinary cotinine analysis. Abstinence is defined as a 75% reduction in carbon monoxide values (parts per million) from smoking baseline levels and a negative urine cotinine measure (<80 ng/mL).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 18-65
  2. Daily smoker for ≥6 months, smoking approximately ≥5 cigarettes per day on average in the past month or must meet the criteria for nicotine dependence
  3. Be interested in quitting smoking (defined as a 2 or above on a 10-point Likert scale assessing readiness and interest in quitting (1=not at all ready/interested, 10=extremely ready/interested)
  4. Willing to engage in a 3-day quit attempt as part of study procedures
  5. Willing to abstain from cannabis use during study procedures (since inhaled cannabis will affect breath carbon monoxide readings).
  6. If female, agreement to use birth control (any form) to avoid pregnancy during study procedures

Exclusion Criteria:

  1. Any serious or unstable medical/psychiatric disorder (including severe substance use disorders, other than tobacco use disorder) in the past month that may interfere with study performance based on PI judgment
  2. Current pregnancy or breastfeeding
  3. Current use of medications with smoking cessation efficacy
  4. Known hypersensitivity to NAC
  5. Use of carbamazepine or nitroglycerin (or any other medication deemed to be hazardous if taken with NAC) within 14 days of study participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737358


Contacts
Contact: Erin A McClure, PhD 843-792-7192 mccluree@musc.edu
Contact: Lori Ann A Ueberroth 843-792-8220 ueberro@musc.edu

Locations
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Robert H Peiffer       peifferr@musc.edu   
Sponsors and Collaborators
Medical University of South Carolina
National Institute on Drug Abuse (NIDA)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Erin McClure, Assistant Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02737358     History of Changes
Other Study ID Numbers: Pro 00052793
R34DA042228 ( U.S. NIH Grant/Contract )
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Erin McClure, Medical University of South Carolina:
nicotine
tobacco
smoking
cessation
N-acetylcysteine
NAC
pharmacotherapy
relapse
tobacco use disorder

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