N-acetylcysteine for Tobacco Use Disorder

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-30

Study Completion Date

2019-10-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Nicotine Dependence Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

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)

Group Type ACTIVE_COMPARATOR

N-acetylcysteine (NAC)

Intervention Type DRUG

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

Interventions

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N-acetylcysteine (NAC)

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

Intervention Type DRUG

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.

Intervention Type OTHER

Other Intervention Names

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NAC

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes