The Potential Effect of Avena Sativa L. on Wellness/Wellbeing During Smoking Reduction/Cessation Experience

Smoking Reduction Clinical Trial

— SMOK  

Official title:

A Double Blind, Randomized, Controlled Study for the Potential Effect of Avena Sativa L. on Wellness/Wellbeing During Smoking Reduction/Cessation Experience

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04749017
• Other study ID #: UCAMCFE-00018
• Status: Completed
• Phase: N/A
• Start date: January 20, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2021
• Source: Universidad Católica San Antonio de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the potential effect of Avena Sativa L. on wellbeing during smoking reduction/cessation

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 the study will be recorded in a diary by each subject.

Subjects are randomized based on the number of cigarettes and the Richmond test. In addition, subjects with a high score on the DASS-21 test items could not participate in the study.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Smoking Reduction

Intervention

Dietary Supplement:
• Experimental product consumption
Consumption of the experimental product 2 capsules daily, morning and evening (450 mg each capsule) for 60 days

Other:
• Control product consumption
Consumption of control product of identical appearance 2 capsules daily for 60 days, morning and evening

Locations

Country	Name	City	State
Spain	Catholic University of Murcia	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

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).