Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06542445
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
The Safety and Efficacy of Terpene-enriched Cannabidiol CBD Oil in ADHD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Safety and Efficacy of Treatment With Cannabidiol CBD Oil Enriched With Terpenes Devoid of THC in Children Diagnosed With ADHD
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
ADHD is the most frequent neurodevelopmental disorder in childhood Symptoms often appear in preschool years and most children 65-80 continue to experience some ADHD-associated symptoms into adolescence and adulthood The disorder is marked by age-inappropriate inattention hyperactivity and impulsivity Drug treatments for ADHD include stimulants containing methylphenidate like Ritalin and Concerta or amphetamines like Vyvanse However 30-35 of the patients do not respond well to these treatments and stimulants may result with various side effects
The use of medical cannabis increases applied for expending medical conditions with growing evidence for its beneficial effects A study on ADHD adults treated by cannabinoids demonstrated improvements in hyperactivity and impulsivity
The current study is aimed to examine the safety and efficacy of treating children diagnosed with ADHD with a CBD oil devoid of THC enriched with terpenes Participants will be randomly assigned to receive either the enriched CBD oil or a placebo for 5 weeks Treatment Stage I
At the end of the treatment stage I an open-label stage will follow II wherein all participants will receive the investigational product for an additional 5 weeks
The investigators hypothesize that children treated with the enriched CBD oil Treatment Stage I will show significantly higher improvement in hyperactivity and inattention scores as compared with the placebo group
The use of medical cannabis increases applied for expending medical conditions with growing evidence for its beneficial effects A study on ADHD adults treated by cannabinoids demonstrated improvements in hyperactivity and impulsivity
The current study is aimed to examine the safety and efficacy of treating children diagnosed with ADHD with a CBD oil devoid of THC enriched with terpenes Participants will be randomly assigned to receive either the enriched CBD oil or a placebo for 5 weeks Treatment Stage I
At the end of the treatment stage I an open-label stage will follow II wherein all participants will receive the investigational product for an additional 5 weeks
The investigators hypothesize that children treated with the enriched CBD oil Treatment Stage I will show significantly higher improvement in hyperactivity and inattention scores as compared with the placebo group
Detailed Description:
Screening phase
Parents who are interested to take part in study will contact the study team Parents will be asked to provide documents attesting their childs medical status and forms required to process a medical cannabis prescription
Visit 1 - Baseline
Participants and parents will sign an Informed Consent Form
Parents will complete questionnaires about the childs health clinical history medications sleep eating habits and quality of life
Participants will be examined by a pediatrician who will fill out a physical examination report including height weight and blood pressure and will conduct an urine test
Participants will conduct a TOVA Test of Variables of Attention test and answer a CBCL Child Behavior Checklist questionnaire
Parents and teachers will complete the Conners questionnaires sent during the screening phase Conners questionnaires may be filled out prior to Visit 1 but no longer than two weeks prior to Visit 1
Participants and parents will receive the study drugplacebo and usage instructions
Treatment using the study drug Stage I will be initiated following Visit 1 according to a schedule set by the study team
Follow-up 1
The study team will contact the parents via a phone call two weeks 2 days after initiation of stage I Parents will answer questions regarding general health and side effects
Visit 2 -at the end of Stage I
Five weeks 3 days after initiation of stage I
Participants and parents will undergo and fill out the same set of examinations and questionnaires as in Visit 1
All participants will receive new bottles of the investigational product - the CBD oil enriched with terpenes open label Stage II
Follow-up 2
The study team will contact the parents via a phone call two weeks 2 days after initiation of Stage II Parents will answer questions regarding general health and side effects
Visit 3 - at the end of Stage II
Five weeks 3 days after initiation of stage II
Participants and parents will undergo and fill out the same set of examinations and questionnaires as in Visit 1 excluding the TOVA test
Study drugs bottles and cannabis use prescription will be returned to the study team
Parents who are interested to take part in study will contact the study team Parents will be asked to provide documents attesting their childs medical status and forms required to process a medical cannabis prescription
Visit 1 - Baseline
Participants and parents will sign an Informed Consent Form
Parents will complete questionnaires about the childs health clinical history medications sleep eating habits and quality of life
Participants will be examined by a pediatrician who will fill out a physical examination report including height weight and blood pressure and will conduct an urine test
Participants will conduct a TOVA Test of Variables of Attention test and answer a CBCL Child Behavior Checklist questionnaire
Parents and teachers will complete the Conners questionnaires sent during the screening phase Conners questionnaires may be filled out prior to Visit 1 but no longer than two weeks prior to Visit 1
Participants and parents will receive the study drugplacebo and usage instructions
Treatment using the study drug Stage I will be initiated following Visit 1 according to a schedule set by the study team
Follow-up 1
The study team will contact the parents via a phone call two weeks 2 days after initiation of stage I Parents will answer questions regarding general health and side effects
Visit 2 -at the end of Stage I
Five weeks 3 days after initiation of stage I
Participants and parents will undergo and fill out the same set of examinations and questionnaires as in Visit 1
All participants will receive new bottles of the investigational product - the CBD oil enriched with terpenes open label Stage II
Follow-up 2
The study team will contact the parents via a phone call two weeks 2 days after initiation of Stage II Parents will answer questions regarding general health and side effects
Visit 3 - at the end of Stage II
Five weeks 3 days after initiation of stage II
Participants and parents will undergo and fill out the same set of examinations and questionnaires as in Visit 1 excluding the TOVA test
Study drugs bottles and cannabis use prescription will be returned to the study team
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None