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

NCT ID: NCT02492022

Last Updated: 2016-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Probiotic L008-1

Encapsuled combinaison of 2 probiotics

Group Type: EXPERIMENTAL

Probiotic L008-1

Intervention Type: DIETARY_SUPPLEMENT

Dosing regimen of 2 capsules daily, once per day, for 14 weeks

Probiotic L008-2

Encapsuled combinaison of 2 probiotics

Group Type: EXPERIMENTAL

Probiotic L008-2

Intervention Type: DIETARY_SUPPLEMENT

Dosing regimen of 2 capsules daily, once per day, for 14 weeks

Placebo

Encapsuled non active ingredients

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Dosing regimen of 2 capsules daily, once per day, for 14 weeks

Interventions

Probiotic L008-1

Dosing regimen of 2 capsules daily, once per day, for 14 weeks

Intervention Type: DIETARY_SUPPLEMENT

Probiotic L008-2

Dosing regimen of 2 capsules daily, once per day, for 14 weeks

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Dosing regimen of 2 capsules daily, once per day, for 14 weeks

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adults aged 18-65 years
• Moderate or heavy smokers as defined by:

a score at the Fargerström Test for Nicotine Dependence ≥ 5, and who smoke more than 10 cigarettes per day.

• Participants willing to stop smoking, corresponding to a score of 6 or 7 to the Motivation To Stop Scale. The MTSS is a one-item questionnaire with 7 possible choices, from 1 (lowest level of motivation to stop smoking) to level 7 (highest level of motivation to stop smoking).
• Participants need to be able to understand and consent to, and willing to comply with study procedures.
• Willingness to discontinue consumption of probiotic supplements and food containing added probiotics or and/or prebiotics (e.g. yoghourts, with live, active cultures or supplements).

Exclusion Criteria

• Positive pregnancy test in women of child-bearing potential
• Pregnant or breast-feeding or planning on becoming pregnant.
• Women of child-bearing potential not using effective contraception, wich include :

Hormonal contraceptives including combined oral contraceptives, hormone birth control patch, vaginal contraceptive ring, injectable contraceptives, or hormonal implants; Intrauterine devices (IUD) or Intrauterine system (IUS); Tubal ligation; Vasectomy of partner; Double barrier method (use of physical barrier by both partners, e.g. male condom and diaphragm, male condom and cervical cap)

• Use of another investigational product within 3 months of the screening visit.
• Currently being treated for any known illnesses or conditions that may impact perceived health such as HIV/AIDS, immune modulating diseases (autoimmune, hepatitis, cancer, etc.), diabetes, kidney or liver disease, gastrointestinal diseases (e.g. gastric ulcers, Crohn's, ulcerative colitis, etc.)
• Suffered or suffering from heart attack, angina, heart arrhythmias, stroke, heart disease, thyroid problems, and diabetes requiring insulin.
• Participants with eczema, psoriasis, dermatitis or urticaria.
• Participants with soy or milk allergy.
• Participants with allergies to adhesive tape or bandages.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MedQualis

INDUSTRY

Sponsor Role: collaborator

Q & T Research

UNKNOWN

Sponsor Role: collaborator

Lallemand Health Solutions

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luc Larrivée, MD

Role: PRINCIPAL_INVESTIGATOR

Q & T Research

Locations

Q & T Research

Sherbrooke, Quebec, Canada

Countries

Canada

Other Identifiers

Smoking Cessation

Identifier Type: -

Identifier Source: org_study_id