Synergistic effects of N-acetylcysteine combined with common psychological interventions on retention in treating and craving reduction, and its effect on quantitative electroencephalographic(QEEG) indices of patients with cannabis use disorder
The purpose of this study is to determine therefore the synergistic effects of N-acetylcysteine combined with common psychological interventions(based on cognitive-behavioral therapy) on retention in treating and craving reduction, and its effect on quantitative electroencephalographic(QEEG) indices of patients with cannabis use disorder
Design
Clinical trial with control group, with parallel groups, double-blind, randomized. The method of randomization will be done by computer software (Stat Trek)
Settings and conduct
The research will be conducted in the Addiction Treatment Clinic of Iran Psychiatric Hospital in Tehran. Samples randomly in two groups; The group receiving N-acetylcysteine (1200 mg per day) with psychotherapy (20 people); and the placebo group with psychotherapy (20 people) are included. Psychological treatment in both groups will be the same based on cognitive-behavioral therapy and individually
Participants/Inclusion and exclusion criteria
Include criteria: Having the criteria for cannabis abuse based on DSM-5, Being between the ages of 18 and 30 years;
Exclude criteria: Having a history of brain damage (epilepsy, convulsions, trauma, etc.), Having other underlying medical diseases such as neurological disorders, etc, History of severe psychiatric comorbidity (including: schizophrenia, bipolar disorder and psychotic disorders), Concomitant use of psychiatric drugs, Concomitant use of drugs of abuse other than smoking
Intervention groups
20 patients in the examination group will receive both psychotherapy (weekly) and N-acetylcysteine (daily) during 12 weeks; 20 patients in the control group will receive psychotherapy (weekly) and placebo (daily) during 12 weeks
Main outcome variables
Dependent variable: craving; Retention in treating; quantitative electroencephalographic (QEEG) indices
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161026030510N5
Registration date:2023-01-07, 1401/10/17
Registration timing:prospective
Last update:2023-01-07, 1401/10/17
Update count:1
Registration date
2023-01-07, 1401/10/17
Registrant information
Name
Reza Arezoomandan
Name of organization / entity
Addiction Department, School of Behavioral Sciences and Mental Health (Institute of Tehran Psychiatr
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 1658
Email address
arezoomandan.r@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-18, 1401/11/29
Expected recruitment end date
2023-05-19, 1402/02/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Synergistic effects of N-acetylcysteine combined with common psychological interventions on retention in treating and craving reduction, and its effect on quantitative electroencephalographic(QEEG) indices of patients with cannabis use disorder
Public title
Synergistic effects of N-acetylcysteine combined with common psychological of patients with cannabis use disorder
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having the criteria for cannabis abuse based on DSM-5
Being between the ages of 18 and 30 years
Exclusion criteria:
Having a history of brain damage (epilepsy, convulsions, trauma, etc)
Having other underlying medical diseases such as neurological disorders, etc
History of severe psychiatric comorbidity (including schizophrenia, bipolar disorder, and psychotic disorders)
Concomitant use of psychiatric drugs
Concomitant use of drugs abuse other than smoking
Age
From 18 years old to 30 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done with a simple method and using random numbers created by computer software (Stat Trek). In this method, the computer chooses random numbers and randomization is done considering the numbers for two groups. For example, even numbers are placed in the experimental group and odd numbers are placed in the control group
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients will not know whether the received drug is a drug or a placebo; the evaluator will not know about the drug group or the placebo of the patients, all evaluations will be done by code
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences,Shahid Hemmat Highway; Next to Milad Tower
City
Tehran
Province
Tehran
Postal code
14665-354
Approval date
2022-11-01, 1401/08/10
Ethics committee reference number
IR.IUMS.REC.1401.622
Health conditions studied
1
Description of health condition studied
Patients with cannabis use disorder
ICD-10 code
F12.12
ICD-10 code description
Cannabis abuse with intoxication
Primary outcomes
1
Description
Craving Score in Craving questionnaire
Timepoint
Before the start of the intervention and 12 weeks after the intervention
Method of measurement
MCQ-SF: marijuana craving questionnaire-shor form
2
Description
Retention in treating
Timepoint
Weekly
Method of measurement
Urine test
3
Description
Quantitative electroencephalographic indice
Timepoint
Before the start of the intervention and 12 weeks after the intervention
Method of measurement
EEG machine
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, 20 patients will receive N-acetylcysteine medicine along with psychotherapy during 12 weeks. The drug will be daily with a dose of 1200 mg per day, the manufacturer of the drug will be Ave Sina. Psychotherapy will be based on the cognitive-behavioral treatment protocol under the supervision of a psychologist specializing in addiction for a weekly session of 60 minutes.
Category
Rehabilitation
2
Description
Control group: In this group, 20 patients will receive placebo along with psychotherapy during 12 weeks. The medicine (Nacetylcysteine medicine in the form of effervescent tablets) and the placebo (without any side effects) will be taken daily. Psychotherapy will also be based on cognitive-behavioral therapy protocol. Psychotherapy sessions by a psychologist specializing in addiction will be individual and weekly sessions of 60 minutes. In this type of psychotherapy, sessions have a specific structure and focus on the patient's thoughts and behavior
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran Psychiatry Hospital
Full name of responsible person
Neda Vahed
Street address
Tehran, km 6 of special road, Azadegan ring road
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 21 4450 3395
Fax
+98 21 4450 3395
Email
iph@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
دکتر کیوانی
Street address
Iran University of Medical Sciences, Highway, next to Milad Tower
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
Adminsite@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Neda Vahed
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Neuroscience
Street address
No. 1, Shahid Mansouri St., Niayesh St., Sattar Khan St
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 914 614 7821
Email
vahedneda@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Neda Vahed
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Neuroscience
Street address
No. 1, Shahid Mansouri St., Niayesh St., Sattar Khan St
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6655 1655
Email
vahedneda@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Neda vahed
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Neuroscience
Street address
No. 1, Shahid Mansouri Street., Niayesh Street., Sattar Khan Street
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6655 1655
Email
Vahedneda@yahoo.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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Clinical and cognitive outcomes of patients after the intervention
When the data will become available and for how long
2023
To whom data/document is available
Researchers
Under which criteria data/document could be used
Researchers from all scientific centers
From where data/document is obtainable
Email
vahedneda@yahoo.com
What processes are involved for a request to access data/document
The email of the requester for data/documents will be answered within 3 weeks