Clinical trial NCT02492022: Efficacy of 2 Probiotics During Nicotine Replacement Therapy on Withdrawal Symptoms Associated With Smoking Cessation
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoking Cessation
Lead sponsor: Lallemand Health Solutions
Sponsor class: INDUSTRY
Collaborators: name: MedQualis
name: Q & T Research
First posted: 2015-07-08
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Evolution of the withdrawal symptoms assessed by the Mood and Physical Symptoms Scale (MPSS)
timeFrame: MPSS will be self-administered daily during 16 weeks
Secondary outcomes:
measure: Evolution of anxiety and depression assessed by the HADS questionnaire
timeFrame: measured 6 times up to 16 weeks
measure: Evolution of nicotine addiction assessed by the Fargerström Test for Nicotine Dependence
timeFrame: measured 3 times up to 16 weeks
measure: Difference in tobacco abstinence between arms, determined by levels of exhaled CO and salivary cotinine dosage
timeFrame: measured 6 times up to 16 weeks
measure: Evolution of body weight
timeFrame: measured 6 times up to 16 weeks
measure: Evolution of food cravings
timeFrame: self-reported, weekly, up to 16 weeks
measure: Tolerance of the probiotics against placebo
timeFrame: up to 16 weeks
measure: Effect of probiotics and smoking cessation on daily bowel movement frequency and consistency, assessed by the Bristol Stool Scale
timeFrame: Self-reported, daily during 16 weeks
measure: Changes in the microbiome composition of participants in the probiotic groups compared to placebo
timeFrame: measured 2 times up to 16 weeks
measure: Recovery of the probiotic strains in the stools
timeFrame: measrured 2 times up to 16 weeks
measure: Evolution of nicotine addiction assessed by a visual analog scale
timeFrame: measured 6 times up to 16 weeks
measure: 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)
timeFrame: MPSS will be self-administered daily during 16 weeks
measure: Correlation between CO levels in exhaled air and salivary cotinine levels
timeFrame: measured 6 times up to 16 weeks
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Q & T Research
state: Quebec
Study officials:
affiliation: Q & T Research
name: Luc Larrivée, MD
role: PRINCIPAL_INVESTIGATOR
References: