Smoking Reduction Clinical Trial
— SMOKOfficial title:
A Double Blind, Randomized, Controlled Study for the Potential Effect of Avena Sativa L. on Wellness/Wellbeing During Smoking Reduction/Cessation Experience
Verified date | October 2021 |
Source | Universidad Católica San Antonio de Murcia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the potential effect of Avena Sativa L. on wellbeing during smoking reduction/cessation
Status | Completed |
Enrollment | 140 |
Est. completion date | December 31, 2021 |
Est. primary completion date | July 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Adults (age: 18 - 65 YO) - Willingness to reduce/quit daily cigarettes (Richmond test) - Regular smokers: =10 CPD for the last 6 months (mean of ~16) - At least 6 months of smoking - Exhaled CO level=10 ppm - Healthy adults: 1. Normal blood profile at screening 2. Subject is in a good physical health as established by medical history, vital signs, self-declaration and physical examination 3. Without depression/ anxiety or stress (based on a psychological evaluation and DASS21 questionnaire) - Able to participate fully in all aspects of the study and had understood and signed the informed consent - Negative drug test (THC, Amphetamines, Methamphetamines, Cocaine and Opioids) - For women: Negative pregnancy test Exclusion Criteria: - Use of any mineral/vitamin/drug or other supplements during the past month prior to study - Participate in another clinical trial in the last 6 months - Using (past 30 days) other smoking cessation aids, for example treatments for tobacco dependence or an investigational drug - Smoke other nicotine-containing products such as hookah smokeless tobacco or electronic cigarettes - Allergic or intolerance to one of the ingredients of the investigated product - Diagnosed or treated for mental illness/ disorder in the past year - Recent history (past year) of alcohol or drug abuse or dependence - Reported any active/chronic disease (such as: Celiac disease/active peptic ulcer) or chronic medications (except Hyperlipidaemia or hypertension that are stable on medications) - Any other laboratory abnormality, medical condition or psychiatric disorder which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject - Pregnant, lactating women or women that plan to get pregnant |
Country | Name | City | State |
---|---|---|---|
Spain | Catholic University of Murcia | Murcia |
Lead Sponsor | Collaborator |
---|---|
Universidad Católica San Antonio de Murcia |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Wellbeing / wellness | WHOQOL BREF test | From baseline to 8 weeks later | |
Secondary | Wellbeing / wellness | WHOQOL BREF test | Day 1, at 4 and 12 weeks later | |
Secondary | Cognitive performance | COMPASS cognitive test panel | Day 1, at 4, 8 and 12 weeks later | |
Secondary | Quality of life panel | Using a visual analog scale where 0=not good at all, 10=very good | Day 1, at 4, 8 and 12 weeks later. They also have to fill it in at home, in a diary, on the 15th, 45th and 75th day. | |
Secondary | Quality of life questionnaire | SF-36 test health questionnaire | Day 1, at 4 and 8 weeks later | |
Secondary | Brief questionnaire of smoking urges | QSU-Brief/Tiffany test | Day 1, at 4 and 8 weeks later | |
Secondary | Depression | Beck depression. Test to measure the level of depression of the subjects | Day 1, at 4 and 8 weeks later | |
Secondary | Perceived stress scale | Scale Remor, 2001. Test to measure the level of stress of the subjects | Day 1, at 4 and 8 weeks later | |
Secondary | Anxiety questionnaire | Test STAI, to measure the level of anxiety of the subjects | Day 1, at 4 and 8 weeks later | |
Secondary | Biopyrrin | Measured in urine | Day 1, at 4 and 8 weeks later | |
Secondary | Cortisol | Measured in saliva | Day 1, at 4 and 8 weeks later | |
Secondary | Nicotine Dependence | Fagerstrom test (FTND) | Day 1, at 4 and 8 weeks later | |
Secondary | Minnesota Nicotine Withdrawal scale | Nicotine withdrawal scale | Day 1, at 4 and 8 weeks later | |
Secondary | Number of cigarettes per day | Cigarettes per day self-reported in the daily diary, validated by cotinine and exhaled carbon monoxide at every visit | Number of daily cigarettes is recorded on a daily basis in the diary from week 1 to week 12. Cotinine and exhaled carbon moxide are measured on day 1, at 4, 8 and 12 weeks later | |
Secondary | Craving level quantification | Visual analog scale where 0=no desire to smoke, 10=strong desire to smoke | Day 1, at 4 and 8 weeks later | |
Secondary | VAS symptoms severity panel | Using a visual analog scale where 0=very low, 10=very high | Day 1, at 4, 8 and 12 weeks later. | |
Secondary | Sleep efficiency | Measured by accelerometry, with Actigraph wGT3X-BT | It will be measured during 3 weekdays and one weekend day, before starting with the consumption of the product and before the end of the consumption (60 days). |
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