Treatment With Cannabis Oil Containing CBD, THC, CBDV or CBG vs. Placebo of Persons With ADHD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-31

Study Completion Date

2022-12-31

Brief Summary

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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

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Detailed Description

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Participants will be screened by study staff for ADHD diagnosis and failure of conventional treatment.

Participants passing the screening will undergo blood and urine tests, fill questionnaires, TOVA test and will be randomized to one of the 4 arms.

Participants will receive the drug, be instructed as per dose titration and as per danger of driving under drug influence.

Telephone follow up will take place weekly after 7 days from starting. Participants will guess to which arm the participant was allocated to after 2 weeks of treatment .

Participants will arrive for a last visit, fill questionnaires, do TOVA test and undergo blood and urine tests.

Participants will be contacted over the phone for a last time, after treatment completion.

Conditions

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ADHD Hyperactivity Attention Deficit

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

each participant will be randomized to one of the 4 arms and will receive the treatment for 32 days. Follow up till 6 weeks from starting

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

the responsible pharmacist is un-blinded

Study Groups

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CBD rich

Cannabis oil oral drops containing 95 mg/ml CBD; 5 mg/ml THC; 15 mg/ml CBDV ; no CBG, once daily Titration from 0.3 to 1.8 ml/day during 21 days

Group Type EXPERIMENTAL