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

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

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

Sponsors & Collaborators

• MedQualis

  collaborator INDUSTRY

• Q & T Research

  collaborator UNKNOWN

• Lallemand Health Solutions

  lead INDUSTRY

Principal Investigators

• Luc Larrivée, MD · Q & T Research

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-05-31

Primary Completion

2016-01-31

Completion

2016-01-31

Countries

• Canada

Study Locations