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

NCT02492022 | Completed Phase 2

• 1 other identifier: Smoking Cessation
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

  MPSS will be self-administered daily during 16 weeks

Secondary Outcomes (12)

• Evolution of anxiety and depression assessed by the HADS questionnaire

  measured 6 times up to 16 weeks

• Evolution of nicotine addiction assessed by the Fargerström Test for Nicotine Dependence

  measured 3 times up to 16 weeks

• Difference in tobacco abstinence between arms, determined by levels of exhaled CO and salivary cotinine dosage

  measured 6 times up to 16 weeks

• Evolution of body weight

  measured 6 times up to 16 weeks

• Evolution of food cravings

  self-reported, weekly, up to 16 weeks

Study Arms (3)

Probiotic L008-1

EXPERIMENTAL

Encapsuled combinaison of 2 probiotics

Dietary Supplement: Probiotic L008-1

Probiotic L008-2

EXPERIMENTAL

Encapsuled combinaison of 2 probiotics

Dietary Supplement: Probiotic L008-2

Placebo

PLACEBO COMPARATOR

Encapsuled non active ingredients

Other: Placebo

Interventions

Probiotic L008-1 DIETARY_SUPPLEMENT

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

Probiotic L008-1

Probiotic L008-2 DIETARY_SUPPLEMENT

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

Probiotic L008-2

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lallemand Health Solutions: lead
• MedQualis: collaborator
• Q & T Research: collaborator

Study Sites (1)

Q & T Research

Sherbrooke, Quebec, J1J2G2, Canada

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Luc Larrivée, MD

  Q & T Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2015
• First Posted: July 8, 2015
• Study Start: May 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: February 18, 2016

Record last verified: 2016-02

Locations

CA (1)