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

February 11, 2022 updated by: Francisco Javier López Román, Universidad Católica San Antonio de Murcia

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Murcia, Spain, 30107
        • Catholic University of Murcia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental group
Avena Sativa L. consumption of 900 mg for 60 days.
Dietary supplement: Experimental product consumption
Consumption of the experimental product 2 capsules daily, morning and evening (450 mg each capsule) for 60 days
Placebo Comparator: Control group
Identically appearing placebo capsules consumed for 60 days.
Other: Control product consumption
Consumption of control product of identical appearance 2 capsules daily for 60 days, morning and evening

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Wellbeing / wellness
Time Frame: From baseline to 8 weeks later
WHOQOL BREF test
From baseline to 8 weeks later

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Wellbeing / wellness
Time Frame: Day 1, at 4 and 12 weeks later
WHOQOL BREF test
Day 1, at 4 and 12 weeks later
Cognitive performance
Time Frame: Day 1, at 4, 8 and 12 weeks later
COMPASS cognitive test panel
Day 1, at 4, 8 and 12 weeks later
Quality of life panel
Time Frame: 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.
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.
Quality of life questionnaire
Time Frame: Day 1, at 4 and 8 weeks later
SF-36 test health questionnaire
Day 1, at 4 and 8 weeks later
Brief questionnaire of smoking urges
Time Frame: Day 1, at 4 and 8 weeks later
QSU-Brief/Tiffany test
Day 1, at 4 and 8 weeks later
Depression
Time Frame: Day 1, at 4 and 8 weeks later
Beck depression. Test to measure the level of depression of the subjects
Day 1, at 4 and 8 weeks later
Perceived stress scale
Time Frame: Day 1, at 4 and 8 weeks later
Scale Remor, 2001. Test to measure the level of stress of the subjects
Day 1, at 4 and 8 weeks later
Anxiety questionnaire
Time Frame: Day 1, at 4 and 8 weeks later
Test STAI, to measure the level of anxiety of the subjects
Day 1, at 4 and 8 weeks later
Biopyrrin
Time Frame: Day 1, at 4 and 8 weeks later
Measured in urine
Day 1, at 4 and 8 weeks later
Cortisol
Time Frame: Day 1, at 4 and 8 weeks later
Measured in saliva
Day 1, at 4 and 8 weeks later
Nicotine Dependence
Time Frame: Day 1, at 4 and 8 weeks later
Fagerstrom test (FTND)
Day 1, at 4 and 8 weeks later
Minnesota Nicotine Withdrawal scale
Time Frame: Day 1, at 4 and 8 weeks later
Nicotine withdrawal scale
Day 1, at 4 and 8 weeks later
Number of cigarettes per day
Time Frame: 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
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
Craving level quantification
Time Frame: Day 1, at 4 and 8 weeks later
Visual analog scale where 0=no desire to smoke, 10=strong desire to smoke
Day 1, at 4 and 8 weeks later
VAS symptoms severity panel
Time Frame: Day 1, at 4, 8 and 12 weeks later.
Using a visual analog scale where 0=very low, 10=very high
Day 1, at 4, 8 and 12 weeks later.
Sleep efficiency
Time Frame: 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).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Católica San Antonio de Murcia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 1, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UCAMCFE-00018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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