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Tests treatment safety and results for Attention Deficit Hyperactivity Disorder (ADHD)
Official title The Safety and Efficacy of Terpene-enriched Cannabidiol (CBD) Oil in ADHD
ClinicalTrials.gov ID: NCT06542445
What this study is testing
What is Oral CBD oil enriched with terpenes?
Oral CBD oil enriched with terpenes is an investigational medicine, being studied as a potential treatment for attention deficit hyperactivity disorder (adhd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 18
You may be able to join if
- Children/adolescents aged 6-18 diagnosed with ADHD as per DSM-V by a neurologist, psychiatrist or other specialist.
- Willing/able to arrive to all the necessary visits as per study protocol.
You likely can't join if
- Participants who used ADHD conventional medications in the month before starting the study or intend to do so during the study.
- Participants who used benzodiazepines or first-generation antihistamines in the week before starting the study or other drugs which may interfere...
- Participants suffering from neurological or psychiatric diseases.
- Participants suffering from neoplastic diseases.
- Participants with syndromes or metabolic diseases.
- Participants with a significant clinic diagnosis which may interfere with the study. May be included later on as per PI opinion.
See the full eligibility criteria
- Children/adolescents aged 6-18 diagnosed with ADHD as per DSM-V by a neurologist, psychiatrist or other specialist.
- Willing/able to arrive to all the necessary visits as per study protocol.
- Participants who used ADHD conventional medications in the month before starting the study or intend to do so during the study.
- Participants who used benzodiazepines or first-generation antihistamines in the week before starting the study or other drugs which may interfere with the study as per PI opinion.
- Participants suffering from neurological or psychiatric diseases.
- Participants suffering from neoplastic diseases.
- Participants with syndromes or metabolic diseases.
- Participants with a significant clinic diagnosis which may interfere with the study. May be included later on as per PI opinion.
- Pregnant or breastfeeding adolescents.
- Sexually active female adolescents who are unwilling to use contraceptives.
- Participants that in the PI opinion will not comply with the protocol in a way that will harm the study (for ex.: not using contraceptives.)
- Participants with less than 18 kg or more than 90 kg weight.
- Participants with BMI lower than 18 or higher than 29.9.
- Participants engaged in another clinical study which includes a medicine.
- Participants engaged in another study regarding ADHD treatment of any kind.
- Participants using alcohol or drugs.
- Past or present use of Cannabis, including medical cannabis Criteria for early termination:
- Use of another medication for ADHD during the study.
- Use of a medication from the exclusion criteria list during the study.
- Use of alcohol or drugs during the study.
- Participants who got pregnant during the study.
- Participants who split the first visit and did not arrive to the second part of the first visit after a maximum of 28 days.
- Participants who did not start the treatment during the 14 days from receiving the drug.
- Non -compliant participants. Criteria for exchange:
- PI may exchange participants that quit, if they did not start treatment for new participants.
- PI may recruit again participants who quit after a new full recruitment process.
The study team makes the final eligibility decision.
Where it's taking place
- Ẕerifin, Israel
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, 6 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ẕerifin, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.