NCT02492022

Efficacy of 2 Probiotics During Nicotine Replacement Therapy on Withdrawal Symptoms Associated With Smoking Cessation

A Double-blind Randomized Placebo-controlled Trial Assessing the Effectiveness of Two Probiotic Products During Nicotine Replacement Therapy for Managing Withdrawal Symptoms Associated With Smoking Cessation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Lallemand Health Solutions · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Smoking Cessation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic L008-1	Dosing regimen of 2 capsules daily, once per day, for 14 weeks
DIETARY_SUPPLEMENT	Probiotic L008-2	Dosing regimen of 2 capsules daily, once per day, for 14 weeks
OTHER	Placebo	Dosing regimen of 2 capsules daily, once per day, for 14 weeks

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2015-07-08
• Last updated: 2016-02-18

Locations

1 site across 1 country: Canada