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Brazilian Journal of Psychiatry

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ORIGINAL ARTICLE • Braz. J. Psychiatr. 42 (5) • Sep-Oct 2020 • https://doi.org/10.1590/1516-4446-2019-0753 copy

N-acetylcysteine as an adjunctive treatment for smoking cessation: a randomized clinical trial

Authorship SCIMAGO INSTITUTIONS RANKINGS

Objective:

This randomized controlled trial examined the efficacy and safety of N-acetylcysteine as an adjunctive treatment for smoking cessation.

Methods:

Heavy smokers were recruited from smoking cessation treatment for this 12- week randomized controlled trial. Eligible tobacco use disorder outpatients (n=34) were randomized to N-acetylcysteine or placebo plus first-line treatment. Abstinence was verified by exhaled carbon monoxide (CO_exh). The assessment scales included the Fagerström Test for Nicotine Dependence, the Hamilton Depression Rating Scale, the Hamilton Anxiety Rating Scale, the Minnesota Nicotine Withdrawal Scale, and the Medication Adherence Rating Scale. We also assessed anthropometrics, blood pressure, lipid profile, and soluble tumor necrosis factor receptor (sTNF-R) levels 1 and 2.

Results:

First-line treatment for smoking cessation plus adjunctive N-acetylcysteine or placebo significantly reduced CO_exh (p < 0.01). In the N-acetylcysteine group, no significant changes were found in nicotine withdrawal symptoms, depressive and anxiety symptoms, anthropometric measures, blood pressure, or glucose compared to placebo. However, there was a significant reduction in sTNF-R2 levels between baseline and week 12 in the N-acetylcysteine group.

Conclusions:

These findings highlight the need to associate N-acetylcysteine with first-line treatment for smoking cessation, since combined treatment may affect inflammation and metabolism components.

Clinical trial registration:

NCT02420418

N-acetylcysteine; inflammation; metabolism; tobacco use; smoking cessation

Variables	Placebo (n=17)	NAC (n=17)	p-value^* * p-value obtained by Student’s t-test or the Wilcoxon signed rank test (for quantitative variables) or by the chi-square test or Fisher’s exact test (for qualitative variables).
Age (years)	46.88 (13.07)	47.06 (9.13)	0.96
Year of education	8.82 (4.89)	9.59 (4.77)	0.65
Gender			0.47
Female	70.60	58.80
Male	29.40	41.20
Pack-years	28.20 (15.80)	35.32 (30.78)	0.90
Age at onset (years)	13.71 (2.66)	15.00 (3.08)	0.21
Years of smoking	33.18 (13.00)	32.31 (8.42)	0.21
Cigarettes day ≥ 20	70.60	52.90	0.29
FTND ≥ 6	47.10	52.90	0.73
Family history of smoking	76.50	87.50	0.41
Maternal smoking in pregnancy	23.50	30.80	0.66
Nicotine replacement therapy
Patch	29.40	47.10	0.29
Bupropion	23.50	52.90	0.08

	Placebo			NAC
Variables	Baseline (n=17)	12 weeks (n=17)	p-value 1^* * p-value 1 obtained for placebo data at baseline and week 12 using Student’s t-test or the Wilcoxon signed rank test (paired data).	Baseline (n=17)	12 weeks (n=17)	p-value 2^† † p-value 2 obtained for NAC data at baseline and week 12 using Student’s t-test or the Wilcoxon signed rank test (paired data).	p-value 3^‡ ‡ p-value 3 obtained for placebo and NAC data at baseline using Student’s t-test or the Wilcoxon signed rank test (independent data).	p-value 4^§ § p-value 4 obtained for placebo and NAC data at week 12 using Student’s t-test or the Wilcoxon signed rank test (independent data).
HDRS-17	8.59 (7.57)	7.00 (6.87)	0.17	6.12 (5.73)	7.06 (7.08)	0.60	0.62	0.67
HAM-A	10.47 (10.97)	7.29 (8.49)	0.20	11.77 (10.83)	11.18 (11.37)	0.81	0.58	0.22
Waist circumference	94.88 (13.55)	94.31 (12.33)	0.63	94.67 (13.56)	99.12 (11.97)	0.07	0.97	0.27
Systolic BP	120.00 (15.06)	119.38 (14.82)	0.83	126.00 (19.57)	124.71 (13.28)	0.99	0.35	0.28
Diastolic BP	78.44 (8.11)	77.19 (9.99)	0.83	77.33 (14.86)	80.88 (13.60)	0.06	0.42	0.51
CO_exh	6.50 (5.07)	0.81 (1.28)	< 0.01	10.54 (6.84)	2.88 (3.06)	< 0.01	0.08	0.02
CO_{exh %}	7.43 (23.70)	0.13 (0.20)	< 0.01	6.56 (17.29)	0.47 (0.49)	< 0.01	0.24	0.06
MNWS	20.07 (13.35)	10.08 (11.07)	0.08	22.69 (9.84)	19.50 (14.28)	0.33	0.57	0.06
BMI	27.57 (5.08)	27.41 (4.38)	0.99	26.72 (4.66)	26.85 (4.52)	0.57	0.62	0.73

	Placebo			NAC
Biomarkers	Baseline (n=17)	12 weeks (n=17)	p-value 1^* * p-value 1 obtained for placebo data at baseline and week 12 using Student’s t-test or the Wilcoxon signed rank test (paired data).	Baseline (n=17)	12 weeks (n=17)	p-value 2^† † p-value 2 obtained for NAC data at baseline and week 12 using Student’s t-test or the Wilcoxon signed rank test (paired data).	p-value 3^‡ ‡ p-value 3 obtained for placebo and NAC data at baseline using Student’s t-test or the Wilcoxon signed rank test (independent data).	p-value 4^§ § p-value 4 obtained for placebo and NAC data at week 12 using Student’s t-test or the Wilcoxon signed rank test (independent data).
Glucose (mg/dL)	96.06 (14.91)	96.93 (12.93)	0.72	102.41 (39.84)	104.80 (51.10)	0.85	0.99	0.6
Insulin (mU/mL)	9.53 (7.28)	9.75 (5.81)	0.64	7.33 (2.85)	8.94 (6.11)	0.29	0.86	0.69
Lipids (mg/dL)
TC	200.41 (36.28)	191.42 (29.53)	0.34	203.29 (37.71)	182.13 (27.39)	< 0.01	0.82	0.38
LDL	124.13 (34.42)	113.60 (26.55)	0.58	129.88 (38.36)	105.13 (28.14)	0.02	0.66	0.40
HDL	50.06 (13.07)	51.20 (15.61)	0.29	41.53 (14.00)	42.53 (12.23)	0.98	0.08	0.10
Triglycerides	128.71 (95.81)	132.67 (78.96)	0.85	168.59 (140.25)	167.40 (105.41)	0.82	0.26	0.32
Castelli I	4.28 (1.43)	4.03 (1.11)	0.16	5.44 (2.20)	4.67 (1.69)	0.02	0.09	0.23
Castelli II	2.58 (0.89)	2.40 (0.80)	0.24	3.50 (1.95)	2.75 (1.37)	0.01	0.34	0.40
Leptin (pg/ml)	2,991.40 (3,018.73)	5,368.16 (3,100.73)	< 0.01	1,745.84 (2,479.72)	3,948.53 (3,150.51)	< 0.01	0.14	0.23
sTNF-R1 (pg/ml)	466.43 (496.36)	1,074.35 (493.96)	< 0.01	408.27 (337.49)	1,047.98 (395.68)	< 0.01	0.99	0.88
sTNF-R2 (pg/ml)	6,544.42 (3,961.29)	4,032.89 (1,289.70)	0.13	6,969.85 (4,086.44)	4,083.03 (1,270.21)	0.01	0.87	0.92

	N-acetylcysteine		Placebo
Medication Adherence Rating Scale questionnaire	Compliance	Non-compliance	Compliance	Non-compliance	p-value^* * p-value obtained by the chi-square test or Fisher’s exact test for qualitative variables.
Do you ever forget to take your medication?	58.80	41.20	56.20	43.80	0.88
Are you careless at times about taking your medication?	76.50	23.50	68.80	31.20	0.62
When you feel better, do you sometimes stop taking your medication?	100.00	0.00	68.80	31.20	0.01
Sometimes if you feel worse when you take the medication, do you stop taking it?	88.20	11.80	87.50	12.50	0.95
I take my medication only when I am sick.	100.00	0.00	75.00	25.00	0.03
It is unnatural for my mind and body to be controlled by medication.	88.20	11.80	68.80	31.20	0.17
My thoughts are clearer on medication.	35.30	64.70	68.80	31.20	0.06
By staying on medication, I can prevent getting sick.	47.10	52.90	56.20	43.80	0.60
I feel weird, like a zombie on medication.	94.10	5.90	100.00	0.00	0.33
Medication makes me feel tired and sluggish.	76.50	23.50	62.50	37.50	0.38

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