Status:
COMPLETED
The Potential Effect of Avena Sativa L. on Wellness/Wellbeing During Smoking Reduction/Cessation Experience
Lead Sponsor:
Universidad Católica San Antonio de Murcia
Conditions:
Smoking Reduction
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the potential effect of Avena Sativa L. on wellbeing during smoking reduction/cessation
Detailed Description
The duration of the study will be 90 days (12 weeks). The consumption time will be set at 60 days (8 weeks), the remaining 30 days will be for follow up, the product will not be consumed. Each day of ...
Eligibility Criteria
Inclusion
- 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:
- Normal blood profile at screening
- Subject is in a good physical health as established by medical history, vital signs, self-declaration and physical examination
- 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
- 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
Key Trial Info
Start Date :
January 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT04749017
Start Date
January 20 2021
End Date
December 31 2021
Last Update
February 15 2022
Active Locations (1)
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1
Catholic University of Murcia
Murcia, Spain, 30107