ADHD Clinical Trial
Official title:
Treatment With Cannabis Oil Containing Canabidiol (CBD) Tetrahydrocannabinol (THC), Cannabidivarin (CBDV) or Cannabigerol (CBG) vs. Placebo of Persons Diagnosed With ADHD After Failure of Conventional Treatment
Verified date | April 2023 |
Source | Brlev Agricultural Crops Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
ADHD is the most frequent neuro-developmental disorder in childhood and often continues into adolescence and adulthood. Indicated drug treatments for ADHD fall into 2 categories: stimulants (such as methylphenidate and amphetamines) and non-stimulants (such as atomoxetine, guanfacine and clonidine) but some persons cannot tolerate their secondary effects or find them non-effective. In the last decade, medical cannabis products have been researched as possible treatment for neurological and mental diseases such as: Post trauma disorder (PTD), autism (ASD), epilepsy, fibromyalgia (FM) and more. Data on the effects of cannabidiol rich cannabis extract use for ADHD seems promising but is still limited. The aim of this study is to investigate if oral cannabinoids given to adults with ADHD affect the symptoms of the disorder. The main objectives of the study are: 1) to characterize the effects of treatment with cannabis oil on symptoms of ADHD; 2) to compare safety and efficacy of cannabis oil products with different CBD,Cannabidivarin (CBDV), cannabigerol (CBG) and THC ratio; 3) and to measure endocannabinoids, THC and CBD and metabolites levels in the blood of the participants. In this study, participants diagnosed with ADHD will be treated with canabidiol-rich cannabis oil and will follow up weekly during approx.1 month (the study period). Blood tests will be performed before and after treatment. Blood tests include blood count, blood chemistry, hormones profile, phyto- and endo- cannabinoids and their metabolites. Test of Variables of Attention test (TOVA) will be administrated before and after treatment
Status | Terminated |
Enrollment | 8 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Participants aged at least 18 y/o diagnosed with ADHD by Diagnostic and Statistical Manual of Mental Disorders (DSM) - Participants with a lower than 0 TOVA score or with a higher than 0 score whom as per investigator opinion suffer from ADHD - Participants who experienced treatment failure with more than one ADHD conventional drug - Participants willing to attend all the visits in the trial. Exclusion Criteria: - Participants who were treated with benzodiazepines, antihistamines, etc, in the week that preceded the trial start. - Participants suffering from neurologic or psychiatric diseases - Participants suffering from malignant diseases - Participants suffering from syndromes or metabolic diseases - Participants with significant clinical diagnosis that can damage the trial unfolding. The investigator may include them after the end of the situation which prevented their previous inclusion. - Participants breastfeeding, pregnant or not willing to use contraceptives. - Participants that will not adhere to the protocol as per investigator opinion - Participants who weight less than 45 kg or more than 120kg or with BMI greater than 30 - Participants participating in another clinical trial which includes drug treatment - Participants receiving any treatment for ADHD - Participants using drugs - Participants using cannabis or products containing cannabinoids, including medical cannabis. |
Country | Name | City | State |
---|---|---|---|
Israel | Shamir (Assaf Harofeh) Medical Center | Be'er Ya'aqov |
Lead Sponsor | Collaborator |
---|---|
Brlev Agricultural Crops Ltd | Bio-Sciences Pharma Ltd. |
Israel,
Cooper RE, Williams E, Seegobin S, Tye C, Kuntsi J, Asherson P. Cannabinoids in attention-deficit/hyperactivity disorder: A randomised-controlled trial. Eur Neuropsychopharmacol. 2017 Aug;27(8):795-808. doi: 10.1016/j.euroneuro.2017.05.005. Epub 2017 May — View Citation
Thomas R, Sanders S, Doust J, Beller E, Glasziou P. Prevalence of attention-deficit/hyperactivity disorder: a systematic review and meta-analysis. Pediatrics. 2015 Apr;135(4):e994-1001. doi: 10.1542/peds.2014-3482. Epub 2015 Mar 2. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | efficacy of cannabis oil on ADHD symptoms as per TOVA test | To assess if participants treated with cannabis oil show an improvement in TOVA scores | 30-35 days | |
Primary | efficacy of cannabis oil on ADHD symptoms as per Conners questionnaire | To assess if participants treated with cannabis oil show an improvement in Conners score | 30-35 days | |
Secondary | to assess side effects and their severity using questionnaire | To examine whether cannabis oil side effects are tolerable and transient | 60 days | |
Secondary | number of participants who dropped-out | to check whether drop out percentage is similar among groups | 60 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03148782 -
Brain Plasticity Underlying Acquisition of New Organizational Skills in Children-R61 Phase
|
N/A | |
Recruiting |
NCT06038942 -
Formal Versus Informal Mindfulness Among University Students With Self-reported ADHD, Nonsuicidal Self-injury, or Stress
|
N/A | |
Not yet recruiting |
NCT06456372 -
Digital Health Intervention for Children With ADHD
|
N/A | |
Completed |
NCT05518435 -
Managing Young People With ADHD in Primary Care Study
|
||
Active, not recruiting |
NCT04978792 -
Does Cultivating Self-compassion Improve Resilience to Criticism and Improve Mental Health in Adults With ADHD?
|
N/A | |
Completed |
NCT03216512 -
Effects of Noise Cancelling Headphones on Neurocognitive and Academic Outcomes in ADHD
|
N/A | |
Completed |
NCT02900144 -
Modified Comprehensive Behavioral Intervention for Tics (M_CBIT)
|
N/A | |
Not yet recruiting |
NCT02906501 -
Effect of Risperidone on Cognitive Functions in Adolescents With ADHD and Behavioral Disturbances
|
N/A | |
Completed |
NCT02829528 -
Little Flower Yoga for Kids: Evaluation of a Yoga and Mindfulness Program for Children With Increased Levels of Emotion Dysregulation and Inattention
|
N/A | |
Completed |
NCT02562469 -
ACTIVATE: A Computerized Training Program for Children With ADHD
|
N/A | |
Terminated |
NCT02271880 -
Improving Medication Adherence in ADHD Adolescents
|
N/A | |
Recruiting |
NCT02255565 -
Dose Response Effects of Quillivant XR in Children With ADHD and Autism: A Pilot Study
|
Phase 4 | |
Completed |
NCT02463396 -
Mindfulness Training in Adults With ADHD
|
N/A | |
Completed |
NCT01673594 -
Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist
|
Phase 4 | |
Terminated |
NCT01733680 -
Amiloride Hydrochloride as an Effective Treatment for ADHD
|
Early Phase 1 | |
Completed |
NCT02300597 -
Internet-based Support for Young People With ADHD and Autism - a Controlled Study
|
N/A | |
Active, not recruiting |
NCT01137318 -
Combined Cognitive Remediation and Behavioral Intervention for Treatment of Attention-deficit/Hyperactivity Disorder (ADHD)
|
Phase 2 | |
Completed |
NCT01404273 -
Functional MRI of Relaxation Response Training in Adults With Attention-Deficit/Hyperactivity Disorder
|
N/A | |
Completed |
NCT00586157 -
Study of Medication Patch to Treat Children Ages 6-12 With ADHD
|
Phase 4 | |
Completed |
NCT00573859 -
The Reinforcing Mechanisms of Smoking in Adult ADHD
|
Phase 1/Phase 2 |