N-acetylcysteine for Tobacco Use Disorder

NCT02737358 | Completed Phase 2 Results

• 2 other identifiers: Pro 00052793R34DA042228
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Nicotine Dependence; Smoking

Keywords

nicotine; tobacco; smoking; cessation; N-acetylcysteine; NAC; pharmacotherapy; relapse; tobacco use disorder

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Biochemically-verified Abstinence From Smoking on Days 1-3 of the 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.

  Days 1-3 of the study protocol

Secondary Outcomes (2)

• Days to Relapse to Smoking Among Abstinent Participants

  Days 4-56 of the study protocol

• Number of Participants With 7-day Point Prevalence Abstinence at the 8-week End-of-treatment Visit

  Days 49-56

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Matched placebo will be given to half of the study participants.

Other: Placebo

N-Acetylcysteine (NAC)

ACTIVE COMPARATOR

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)

Interventions

N-acetylcysteine (NAC) DRUG

NAC or matched placebo will be given to study participants for 8 weeks.

Also known as: NAC

N-Acetylcysteine (NAC)

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65
• 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
• 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)
• Willing to engage in a 3-day quit attempt as part of study procedures
• Willing to abstain from cannabis use during study procedures (since inhaled cannabis will affect breath carbon monoxide readings).
• If female, agreement to use birth control (any form) to avoid pregnancy during study procedures

You may not qualify if:

• 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
• Current pregnancy or breastfeeding
• Current use of medications with smoking cessation efficacy
• Known hypersensitivity to NAC
• Use of carbamazepine or nitroglycerin (or any other medication deemed to be hazardous if taken with NAC) within 14 days of study participation

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

• Tomko RL, Gray KM, Oppenheimer SR, Wahlquist AE, McClure EA. Using REDCap for ambulatory assessment: Implementation in a clinical trial for smoking cessation to augment in-person data collection. Am J Drug Alcohol Abuse. 2019;45(1):26-41. doi: 10.1080/00952990.2018.1437445. Epub 2018 Mar 7.

  PMID: 29513609 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking; Recurrence

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Erin A. McClure, Ph.D.
• Organization: Medical University of South Carolina

mccluree@musc.edu

843-792-7192

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 14, 2016
• First Posted: April 13, 2016
• Study Start: August 30, 2016
• Primary Completion: August 1, 2019
• Study Completion: October 10, 2019
• Last Updated: August 17, 2020
• Results First Posted: August 17, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)