Investigating the effectiveness of psilocybe cubensis extract assisted psychotherapy on alcohol consumers willing to quit in Tehran: a randomized control trial study
Investigating the effectiveness of Psilocybe cubensis mushroom extract along with psychotherapy on reducing alcohol consumption
Design
A clinical trial with a control group, with parallel groups (microdose and macrodose), single blind, randomized, sample size: 45 patients. The rand function of Excel software was used for randomization.
Settings and conduct
The place of study is Tehran. After reviewing the study entry criteria, people will be randomly divided into three control groups, microdose and macrodose. The method of random division will be computerized and the allocation ratio is 1:1:1. The design model of this study is a randomized controlled trial in parallel with one blind strain (participants).
The experimental group will undergo weekly psychotherapy. In the meetings, the symptoms of depression, anxiety and their level of motivation are checked. The microdose of the extract will also be started for four weeks (two microdoses per week) at the same time as psychotherapy begins. A macrodose of Psilocybe cubensis extract will also be provided in the third and sixth weeks.
Participants/Inclusion and exclusion criteria
Desire and motivation to quit alcohol; minimum Reading and Writing skills; informed consent to participate in the study; the most common and dominant substance consumed in the last three months is alcohol
Intervention groups
First group: macrodose (extract of 1 and 2.5 grams of Psilocybe cubensis) with a two-week interval + psychotherapy.
The second group: microdose (0.5 g Psilocybe cubensis extract) weekly + psychotherapy. Control group: control group with placebo + psychotherapy
Main outcome variables
Reducing alcohol consumption; increasing treatment motivation; reducing depression and anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181224042100N2
Registration date:2024-05-31, 1403/03/11
Registration timing:prospective
Last update:2024-05-31, 1403/03/11
Update count:0
Registration date
2024-05-31, 1403/03/11
Registrant information
Name
Mahdi Fatemizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6636 7569
Email address
m4567458@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-05, 1403/04/15
Expected recruitment end date
2024-11-21, 1403/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of psilocybe cubensis extract assisted psychotherapy on alcohol consumers willing to quit in Tehran: a randomized control trial study
Public title
Effect of psilocybe cubensis in Alcohol Consumption
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Desire and motivation to quit alcohol
Minimum reading and writing literacy
Informed consent to participate in the study
The most common and dominant substance used in the last three months is alcohol
age between 18-60
Exclusion criteria:
Schizophrenia spectrum disorders
History of cardiovascular diseases
History of high blood pressure
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
After the clinical interview and review of the study entry criteria, the participants will be randomly divided into three control groups, microdose and macrodose. The method of random distribution of participants will be computerized and the allocation ratio is 1:1:1. First, each participant receives an identification number, and that number is provided to the computer, and the arrangement of each number according to the mentioned ratio is done by the computer. The design model of this study is a randomized controlled trial in parallel.
Blinding (investigator's opinion)
Single blinded
Blinding description
Only the participants in this study are blinded to the group they are assigned to.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Shahid Sadoughi University of Medical Sciences
Street address
Central Organization of the University of Medical Sciences and Health Services, Dr Bahonar Square, Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2023-12-13, 1402/09/22
Ethics committee reference number
IR.SSU.REC.1402.132
Health conditions studied
1
Description of health condition studied
Alcohol Consumption
ICD-10 code
F10.14
ICD-10 code description
Alcohol abuse with alcohol-induced mood disorder
Primary outcomes
1
Description
Depression score in Beck questionnaire
Timepoint
From the beginning of the study (before the start of the intervention) until the eighth week - every week
Method of measurement
Beck depression questionnaire
2
Description
Anxiety score in Beck questionnaire
Timepoint
From the beginning of the study (before the start of the intervention) until the eighth week - every week
Method of measurement
Beck Anxiety questionnaire
3
Description
Alcohol consumption
Timepoint
From the beginning of the study (before the start of the intervention) until the eighth week - every week
Method of measurement
Self Report
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: first. Microdose Group: After obtaining a research and ethical license, Horshid Ahura Mazda Pars Company with registration number 4380 and national ID number 14008439520 will be able to produce and prepare Psilocybe cubensis mushroom in the amount considered for the study. The microdose test group will undergo weekly psychotherapy at the beginning of the study. In each psychotherapy session, the symptoms of depression, anxiety and their level of motivation to continue the treatment will be evaluated. The microdose of Psilocybe cubensis extract will also be started for four weeks (two microdoses per week) at the same time as psychotherapy begins. Microdose (0.5 gram Psilocybe cubensis extract)
Category
Treatment - Drugs
2
Description
Intervention group: second.: At the beginning of the study, the macrodose experimental group will undergo weekly psychotherapy. In each psychotherapy session, the symptoms of depression, anxiety and their level of motivation to continue the treatment will be evaluated. A macrodose of Psilocybe cubensis extract will also be provided in the third and sixth weeks. From the first week to the eighth week of the study, interview and psychotherapy sessions are ongoing for all three groups. Macrodose (1 and 2.5 grams of Psilocybe cubensis extract)
Category
Treatment - Drugs
3
Description
Control group: Control group with placebo + psychotherapy. Psychotherapy sessions will be accompanied by placebo medication
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Purnamdari Psychiatry Clinic
Full name of responsible person
Mahdi Pournamdari
Street address
Unit 4, 2nd Floor, No. 53, Golestan Dead End, Corner of Kurdistan Autobahn, above Homa Hotel, vanak, Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8887 3412
Email
m4567458@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amin Salehi Abargouei
Street address
Central Administration, Bahonar Sq., Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3725 8410
Email
info@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahdi Fatemizadeh
Position
Ph.D. Candidate
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Tehran University of Medical Sciences, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
81633102
Email
Sm.fatemizadeh72@GMAIL.COM
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahdi Fatemizadeh
Position
Ph.D. Candidate
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Tehran University of Medical Sciences, Keshavarz Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
81633102
Email
sm.fatemizadeh72@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahdi Fatemizadeh
Position
Ph.D. Candidate
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
TUMS, Keshavarz Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
81633102
Email
sm.fatemizadeh72@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Demographic information and final scores of questionnaires as well as the output data of laboratory tests are shared.
When the data will become available and for how long
Start access after printing the results
To whom data/document is available
Researchers of all universities of medical sciences
Under which criteria data/document could be used
The final score of the questionnaires and the final results can be used in the review analysis.
From where data/document is obtainable
To receive documents, contact Mehdi Fatemizadeh: Phone: 009154567458
Email: Sm.fatemizadeh72@gmail.com
What processes are involved for a request to access data/document
A written request is given via email and the documents will be available after authentication.