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

Universidad Católica San Antonio de Murcia

Status: Completed

Conditions: Smoking Reduction

Treatments: Other: Control product consumption; Dietary Supplement: Experimental product consumption

Study type: Interventional

Funder types: Other

Identifiers

NCT04749017

UCAMCFE-00018

Details and patient eligibility

About

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

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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140 participants in 2 patient groups, including a placebo group

Experimental group

Experimental group

Description:

Avena Sativa L. consumption of 900 mg for 60 days.

Treatment:

Dietary Supplement: Experimental product consumption

Control group

Placebo Comparator group

Description:

Identically appearing placebo capsules consumed for 60 days.

Treatment:

Other: Control product consumption