Quitting smoking is a big decision, a decision to achieve better health. Trying to quit smoking can be stressful. The prospect of dealing with withdrawal symptoms, fear or failure to change the routine, can also be sources of stress. Withdrawal from nicotine is characterized by symptoms that include anxiety, irritability, hunger and cravings for more tobacco. Nicotine creates a dependency so that the body develops a need for a certain level of nicotine at all times. Unless that level is maintained symptoms of withdrawal appear. For tobacco users trying to quit, symptoms of withdrawal from nicotine are unpleasant and stressful, but they are temporary. Research has demonstrated the relative effectiveness of pharmacotherapy treatments in smoking cessation but no studies have examined the effects of the probiotics on the withdrawal symptoms associated with the tobacco cessation during nicotine replacement therapy (NRT). The purpose of this study is to assess the effectiveness of two probiotic products during NRT for managing withdrawal symptoms associated with smoking cessation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
75
Dosing regimen of 2 capsules daily, once per day, for 14 weeks
Dosing regimen of 2 capsules daily, once per day, for 14 weeks
Dosing regimen of 2 capsules daily, once per day, for 14 weeks
Q & T Research
Sherbrooke, Quebec, Canada
Evolution of the withdrawal symptoms assessed by the Mood and Physical Symptoms Scale (MPSS)
The MPSS(M) score, corresponding to the sum of the 7 items of the MPSS mood subscale, will be compared between groups, daily between week 2 and 4 (first 2 weeks of tobacco abstinence) and week 12 and 14 (first 2 weeks after the end of NRT), and weekly for the other weeks. For weekly comparisons, an average of daily scores will be done for the respective weeks. The score will also be compared in time within groups, using the baseline ratings as covariates
Time frame: MPSS will be self-administered daily during 16 weeks
Evolution of anxiety and depression assessed by the HADS questionnaire
Time frame: measured 6 times up to 16 weeks
Evolution of nicotine addiction assessed by the Fargerström Test for Nicotine Dependence
Time frame: measured 3 times up to 16 weeks
Difference in tobacco abstinence between arms, determined by levels of exhaled CO and salivary cotinine dosage
Time frame: measured 6 times up to 16 weeks
Evolution of body weight
Time frame: measured 6 times up to 16 weeks
Evolution of food cravings
Assessed by the Food Cravings Self-Questionnaire
Time frame: self-reported, weekly, up to 16 weeks
Tolerance of the probiotics against placebo
Assessed by the reporting and the comparison of the Adverse events occurred in the different arms
Time frame: up to 16 weeks
Effect of probiotics and smoking cessation on daily bowel movement frequency and consistency, assessed by the Bristol Stool Scale
Time frame: Self-reported, daily during 16 weeks
Changes in the microbiome composition of participants in the probiotic groups compared to placebo
Assessed by the analyse of the stool samples collected
Time frame: measured 2 times up to 16 weeks
Recovery of the probiotic strains in the stools
Assessed by the change in the probiotic strains concentration in the stools samples collected in all three arms.
Time frame: measrured 2 times up to 16 weeks
Evolution of nicotine addiction assessed by a visual analog scale
Time frame: measured 6 times up to 16 weeks
Comparison of MPSS(Craving or C), MPSS(Physical symptoms or P), and MPSS total scores (corresponding to the sum of MPSS(M), MPSS(C) and MPSS(M) scores)
daily comparison between week 2 and 4 (first 2 weeks of tobacco abstinence) and week 12 and 14 (first 2 weeks after the end of NRT), and weekly for the other weeks. The scores will be also compared in time within groups, using the baseline ratings as covariates. For weekly comparisons, an average of daily scores will be done for the respective weeks
Time frame: MPSS will be self-administered daily during 16 weeks
Correlation between CO levels in exhaled air and salivary cotinine levels
Time frame: measured 6 times up to 16 weeks
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