Protocol summary
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Study aim
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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
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Design
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Clinical trial with control group, with parallel groups, double-blind, randomized. The method of randomization will be done by computer software (Stat Trek)
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Settings and conduct
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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 twice a 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
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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
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Main outcome variables
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Dependent variable: craving; Retention in treating; quantitative electroencephalographic (QEEG) indices
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20161026030510N5
Registration date:
2023-01-07, 1401/10/17
Registration timing:
prospective
Last update:
2024-07-18, 1403/04/28
Update count:
1
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Registration date
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2023-01-07, 1401/10/17
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-02-18, 1401/11/29
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Expected recruitment end date
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2023-05-19, 1402/02/29
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Synergistic effects of N-acetylcysteine combined with common psychological of patients with cannabis use disorder
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 30 years old
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Gender
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Male
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Phase
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3
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Groups that have been masked
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- Participant
- Outcome assessor
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-11-01, 1401/08/10
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Ethics committee reference number
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IR.IUMS.REC.1401.622
Health conditions studied
1
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Description of health condition studied
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Patients with cannabis use disorder
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ICD-10 code
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F12.12
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ICD-10 code description
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Cannabis abuse with intoxication
Primary outcomes
1
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Description
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Craving Score in Craving questionnaire
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Timepoint
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Before the start of the intervention and 12 weeks after the intervention
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Method of measurement
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MCQ-SF: marijuana craving questionnaire-shor form
2
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Description
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Retention in treating
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Timepoint
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Weekly
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Method of measurement
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Urine test
3
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Description
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Quantitative electroencephalographic indice
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Timepoint
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Before the start of the intervention and 12 weeks after the intervention
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Method of measurement
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EEG machine
Intervention groups
1
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Description
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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 twice a 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.
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Category
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Rehabilitation
2
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Description
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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
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Clinical and cognitive outcomes of patients after the intervention
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When the data will become available and for how long
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2023
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To whom data/document is available
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Researchers
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Under which criteria data/document could be used
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Researchers from all scientific centers
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From where data/document is obtainable
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Email
vahedneda@yahoo.com
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What processes are involved for a request to access data/document
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The email of the requester for data/documents will be answered within 3 weeks
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Comments
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