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N-acetylcysteine for Tobacco Use Disorder

Primary Purpose

Nicotine Dependence, Smoking

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

N-acetylcysteine (NAC)

Placebo

About this trial

This is an interventional treatment trial for Nicotine Dependence focused on measuring nicotine, tobacco, smoking, cessation, N-acetylcysteine, NAC, pharmacotherapy, relapse, tobacco use disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

N-Acetylcysteine (NAC)

Arm Description

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

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Days to Relapse to Smoking Among Abstinent Participants

Relapse to smoking will be measured through carbon monoxide-verified relapse at weekly study visits among those who abstained during the 3-day quit attempt. 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).

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

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).

Full Information

NCT ID

NCT02737358

First Posted

March 14, 2016

Last Updated

July 31, 2020

Sponsor

Medical University of South Carolina

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT02737358

Brief Title

N-acetylcysteine for Tobacco Use Disorder

Official Title

Evaluating N-acetylcysteine as a Pharmacotherapy for Tobacco Use Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

August 30, 2016 (Actual)

Primary Completion Date

August 1, 2019 (Actual)

Study Completion Date

October 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of South Carolina

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nicotine Dependence, Smoking

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

114 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

N-Acetylcysteine (NAC)

Arm Type

Active Comparator

Arm Description

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)

Intervention Type

Drug

Intervention Name(s)

N-acetylcysteine (NAC)

Other Intervention Name(s)

NAC

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Days 1-3 of the study protocol

Secondary Outcome Measure Information:

Title

Days to Relapse to Smoking Among Abstinent Participants

Description

Time Frame

Days 4-56 of the study protocol

Title

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

Description

Time Frame

Days 49-56

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

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

Plan to Share IPD

Yes

Citations:

PubMed Identifier

29513609

Citation

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.

Results Reference

derived

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N-acetylcysteine for Tobacco Use Disorder

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