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Cannabidiol as an Add-on Treatment to substance abuse in juvenile patients with PSYchosis: a double-blind randomized placebo-controlled study.
EU CTIS ID: 2024-514393-44-00
What this study is testing
The primary objective is to demonstrate that CBD is a valid augmentation therapy to a long-acting/oral antipsychotic treatment in juvenile subjects who meet DSM-5 criteria for Cannabis Use Disorder and for Substance-Induced Psychotic Disorder in terms of: cannabis use relapse symptoms in CBD-group compared to placebo-group. The incidence of cannabis abuse relapse symptoms will be assessed by a specific questionnaire, the Addiction Severity Index (ASI, no cut-off). This scale will be administered to every enrolled subject by the same operator, every 28 days, for a total of 6 months, in order to favor a consistent approach. All the scores will be collected in a database and statistical analyses will be performed at the end of the treatment period. The score trend of the questionnaire will be analyzed for both the CBD-group and the placebo-group. Afterwards, we will perform a comparison of final scores between the two groups.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed informed consent by the subject or parent/legal guardian in case of a subject under the age of 18, indicating that the subject understands the purpose of and procedures required for the study before the initiation of any study specific procedures. Subjects who are unable to provide informed consent will not be included in the study.
- Dosage of Beta-HCG in serum or urinary pregnancy test will be performed to every womaen of childbearing age before the treatment period and every 25+30 days to comply with the recommendations of the Clinical Trial Facilitation Group (CTFG) since CBD is potentially genotoxic. Also, since aripiprazole is potentially teratogenic, we acknowledge the importance of evaluating potential pregnancy through regular pregnancy tests and we will discuss with the patients regarding these theme (including evaluating with the patients’ planned pregnancy after the withdrawal of the drug etc). However, since all patients enrolled that present a good response to aripiprazole treatment in absence of relevant side effects, will continue with aripiprazole LAI after the end of this project and likely for a long time, all the good clinical practice actions required by the treatment with aripiprazole will be ensured even after the end of the trial. Regarding the pregnancy test, all the actions needed by the treatment with aripiprazole LAI will be performed even after the end of the study, since they represent good clinical practice.
- Oral aripiprazole will then be switched to treatment with intramuscular injection of long-acting aripiprazole.
- Highly effective contraceptive measures under specific CTFG recommendations are required
- Signed acknowledgment of responsibilities by an identified informant before the initiation of any activities required by the study for the designated informant.
- Male or female subjects between the age of 15 and 25, inclusive.
You likely can't join if
- Failure to perform screening or baseline examinations.
- Previous hospitalization for psychiatric disorders.
- Concomitant antipsychotic medication other than aripiprazole.
- Subjects consume more than 2 unit of alcohol (each unit correspond to 12g of pure alcohol) per day.
- History of a hypersensitivity reaction to aripiprazole or cannabidiol (anaphylactic reaction, angioedema, laryngospasm, pruritus/urticaria, or oropharyngeal spasm).
- History of hepatic impairment, renal impairment, cardiovascular disease such as history of myocardial infarction or ischemic heart disease, heart failure or conduction abnormalities, cerebrovascular disorder, conditions that may predispose to hypotension such as dehydration, hypovolemia and treatment with antihypertensive medicinal products or hypertension, including accelerated or malignancy, history of venous thromboembolism, prolongation of the QT interval, tardive dyskinesia, neuroleptic malignant syndrome (SNM), convulsions.
See the full eligibility criteria
- Signed informed consent by the subject or parent/legal guardian in case of a subject under the age of 18, indicating that the subject understands the purpose of and procedures required for the study before the initiation of any study specific procedures. Subjects who are unable to provide informed consent will not be included in the study.
- Dosage of Beta-HCG in serum or urinary pregnancy test will be performed to every womaen of childbearing age before the treatment period and every 25+30 days to comply with the recommendations of the Clinical Trial Facilitation Group (CTFG) since CBD is potentially genotoxic. Also, since aripiprazole is potentially teratogenic, we acknowledge the importance of evaluating potential pregnancy through regular pregnancy tests and we will discuss with the patients regarding these theme (including evaluating with the patients’ planned pregnancy after the withdrawal of the drug etc). However, since all patients enrolled that present a good response to aripiprazole treatment in absence of relevant side effects, will continue with aripiprazole LAI after the end of this project and likely for a long time, all the good clinical practice actions required by the treatment with aripiprazole will be ensured even after the end of the trial. Regarding the pregnancy test, all the actions needed by the treatment with aripiprazole LAI will be performed even after the end of the study, since they represent good clinical practice.
- Oral aripiprazole will then be switched to treatment with intramuscular injection of long-acting aripiprazole.
- Highly effective contraceptive measures under specific CTFG recommendations are required
- Signed acknowledgment of responsibilities by an identified informant before the initiation of any activities required by the study for the designated informant.
- Male or female subjects between the age of 15 and 25, inclusive.
- Clinical diagnosis of Substance-Induced Psychosis according to DSM-5. This diagnosis can be established utilizing the SCID-I, direct clinical assessments, family, informants, and confirmation of diagnosis from clinical sources.
- Clinical diagnosis of Cannabis Use Disorder according to DSM-5. This diagnosis can be established utilizing the SCID-I, direct clinical assessments, family, informants, and confirmation of diagnosis from clinical sources.
- Heavy consumption at least in the previous six months before enrolment (presence of 6 or more symptoms of Cannabis Use Disorder DSM-5 Criteria).
- Subjects must have been on treatment with oral aripiprazole for at least 2 weeks and a maximum duration of 6 months prior to enrolment to exclude the presence of side effects.
- Onset of symptoms < 5 years.
- Failure to perform screening or baseline examinations.
- Previous hospitalization for psychiatric disorders.
- Concomitant antipsychotic medication other than aripiprazole.
- Subjects consume more than 2 unit of alcohol (each unit correspond to 12g of pure alcohol) per day.
- History of a hypersensitivity reaction to aripiprazole or cannabidiol (anaphylactic reaction, angioedema, laryngospasm, pruritus/urticaria, or oropharyngeal spasm).
- History of hepatic impairment, renal impairment, cardiovascular disease such as history of myocardial infarction or ischemic heart disease, heart failure or conduction abnormalities, cerebrovascular disorder, conditions that may predispose to hypotension such as dehydration, hypovolemia and treatment with antihypertensive medicinal products or hypertension, including accelerated or malignancy, history of venous thromboembolism, prolongation of the QT interval, tardive dyskinesia, neuroleptic malignant syndrome (SNM), convulsions.
- Any other Axis I psychiatric disorder according to DSM 5.
- Any personality disorders according to DSM 5.
- DSM 5 criteria for alcohol abuse.
- History of traumatic head injury with loss of consciousness.
- History of epilepsy or other neurological or medical diseases.
- Mental retardation (assessed through the Wechsler Adult Intelligence Scale “WAIS”).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.