AutismPhase 2TECANCT07199218
Placebo-Controlled Study of Terpenes-Enriched Cannabis Oil T1/C28 for Children With Autism
A Phase 2 study testing Terpenes-Enriched CBD-Predominant Oil and Terpenes-Enriched CBD Oil (THC-Free) in people with Autism and Autism Spectrum Disorder, run by Bazelet Nehushtan LtD. at 1 site in Israel.
Trial summary
The goal of this clinical trial is to determine whether cannabidiol (CBD, 28%) combined with terpenes and a small amount of THC (1%) can help reduce symptoms of autism, and to evaluate the safety of this treatment. The main questions are: 1. Does this treatment improve behavioral challenges in children with autism? 2. Read more about this study
- Who is it for?
- Ages 4 to 13 years
- Conditions the study is for
- Autism, Autism Spectrum Disorder
- What is being tested?
- Terpenes-Enriched CBD-Predominant Oil and Terpenes-Enriched CBD Oil (THC-Free)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteIsrael
- Study dates
- 5 Oct 2025to 3 Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 4 to 12 years (after the 4th birthday and before the 13th).
- Diagnosis of autism spectrum disorder (ASD) according to DSM-5, confirmed by Childhood Autism Rating Scale-Second Edition (CARS-2).
- Moderate or greater ASD-associated symptoms, defined as a rating of ≥4 ("moderate" or higher) on the Overall Function Clinical Global Impression-Severity (CGI-S).
- Aberrant Behavior Checklist-Irritability subscale (ABC-I) score ≥18.
- Social Responsiveness Scale-Second Edition (SRS-2) total T score ≥66.
Who cannot join
- Body weight <12.5 kg or ≥57.5 kg.
- Current or past diagnosis of heart failure, drug addiction, schizophrenia, psychosis, bipolar disorder, post-traumatic stress disorder (PTSD), or major depressive disorder (MDD), or diagnosis of schizophrenia in a first-degree relative.
- Seizure or change in antiepileptic medications within 4 months prior to randomization.
- Clinically significant abnormalities on physical examination or laboratory testing, including impairment in cardiac, hepatic, or renal function.
- Change in pharmacological or behavioral treatment, or change in home or school environment (other than school holidays), within 4 weeks prior to randomization or planned during the study.
- Cannabinoid treatment within 4 weeks prior to randomization.
- Predicted poor compliance with study procedures (e.g., blood tests).
- Concurrent use of opiates or alcohol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Daniel Korenfine contact
Israel1 site, 1 recruiting
- Recruiting
Shaare Zedek Medical Center
Jerusalem, N/A = Not Applicable, 9640610
Adi Aran, MD, 0508685034, aaran@szmc.org.il
Daniel Korenfine, danielko@szmc.co.il
About this study
Official title: A Phase 2, Placebo-Controlled, Randomized, Double-Blind Study to Assess the Safety, Tolerability and Efficacy of Terpenes-enriched Cannabis Oil T1/C28, Administered to Pediatric Subjects With Autism Spectrum Disorder (ASD)
The goal of this clinical trial is to determine whether cannabidiol (CBD, 28%) combined with terpenes and a small amount of THC (1%) can help reduce symptoms of autism, and to evaluate the safety of this treatment.
The main questions are:
Read more
- Does this treatment improve behavioral challenges in children with autism?
- Does this treatment improve social difficulties in children with autism?
What will happen in the study:
- Participants take either the study treatment or a placebo (a look-alike substance with no active drug) every day for 2 months.
- After 2 months, all participants receive the study treatment or a similar treatment without THC for another 2 months.
- Participants come to the clinic once every 2 months for checkups and tests.
Read the detailed description
Autism spectrum disorder (ASD) is a condition that affects communication, social interaction, and behavior. Current medications do not treat the core symptoms of autism, and the drugs sometimes prescribed (such as antipsychotics for irritability) can cause significant side effects.
Cannabidiol (CBD) is a natural, non-psychoactive compound from the cannabis plant that may reduce brain overactivity and inflammation. Tetrahydrocannabinol (THC), the psychoactive component of cannabis, acts on the endocannabinoid system, which is thought to function differently in people with autism. Research suggests that CBD combined with very small amounts of THC may improve behavior and social functioning. Other plant compounds called terpenes may enhance the effects of CBD and THC, even at low doses.
This study tests whether a CBD oil enriched with terpenes and a very small amount of THC is safe and effective for children with autism. Seventy-eight children, ages 4-13, will participate. Half will receive the study oil and half will receive a placebo (an inactive oil that looks the same) for 8 weeks. Afterward, all participants will receive an active treatment for another 8 weeks.
The study evaluates whether the treatment improves behavior, social skills, and quality of life. Safety is monitored through regular clinic visits, questionnaires, physical exams, and blood tests.
- Conditions
- Autism, Autism Spectrum Disorder
- Being tested
- Terpenes-Enriched CBD-Predominant Oil, Placebo, Terpenes-Enriched CBD Oil (THC-Free)
- Keywords
- autism, ASD, cannabidiol, terpenes, THC
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Terpenes-Enriched CBD-Predominant OilDrug
Oral cannabidiol (CBD; 7.2 mg/kg/day), tetrahydrocannabinol (THC; 0.257 mg/kg/day, equivalent to 1:28 of the CBD dose), and terpenes (0.5 mg/kg/day), administered in two daily doses. The formulation is an olive oil-based solution (CBD/THC: 280/10 mg per g) produced by Bazelet Group, Israel.
PlaceboDrug
Oral olive oil with added flavors to mimic the appearance, texture, and taste of the study drug, administered in two daily doses.
Terpenes-Enriched CBD Oil (THC-Free)Drug
Oral cannabidiol (CBD; 7.2 mg/kg/day) and terpenes (0.5 mg/kg/day), administered in two daily doses. The formulation is an olive oil-based solution (CBD- 280 mg per g) produced by Bazelet Group, Israel.
| Study group | Role | What they receive |
|---|---|---|
| Terpenes-Enriched CBD-Predominant Oil | Experimental | Oral cannabidiol (CBD), tetrahydrocannabinol (THC; 1/28 of the CBD dose), and terpenes, administered for 8 weeks as an add-on to existing treatments. After the first 8 weeks, participants will continue with the same treatment for an additional 8 weeks. Receives: Drug: Terpenes-Enriched CBD-Predominant Oil |
| Placebo | Placebo comparator | Oral olive oil with flavoring to mimic the texture and taste of the study drug, given for 8 weeks. After the first 8 weeks, participants will switch to terpenes-enriched CBD oil without THC for another 8 weeks. Receives: Drug: Placebo; Drug: Terpenes-Enriched CBD Oil (THC-Free) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Aberrant Behavior Checklist-Community (ABC-C): Irritability Subscale raw score (ABC-I)
The ABC-C is a caregiver-completed questionnaire with 58 items, divided into five subscales. The ABC-I (Irritability) subscale includes 15 items that assess emotional and behavioral symptoms of ASD, such as aggression toward others, deliberate self-injury, temper tantrums, depressed mood, and rapidly shifting moods. Scores on this subscale range from 0 to 45, with higher scores indicating greater severity. Change from baseline to Week 8 is reported, with lower scores reflecting clinical improvement.
Measured: Baseline to Week 8
Secondary outcomes (7)
Change From Baseline in Vineland™-III Adaptive Behavior Scales (VABS3) Socialization Domain Standard Score
The VABS-3 Socialization domain measures interpersonal relationships, play and leisure, and coping skills, reflecting the individual's ability to engage in age-appropriate social interactions. Higher scores indicate better adaptive social functioning.
Measured: Baseline to Week 8
Change From Baseline in Social Responsiveness Scale-2nd edition (SRS-II) total raw score
The SRS-2 measures the severity of social impairment associated with autism spectrum disorder. It includes five subscales: Social Awareness (8 items), Social Communication (22 items), Social Cognition (12 items), Social Motivation (11 items), and Restricted Interests and Repetitive Behavior (12 items). Two summary scores are derived: the Total Score (sum of all five subscales) and the Social Communication and Interaction (SCI) score, which combines the four social subscales excluding Restricted Interests and Repetitive Behavior. The SCI and RRB correspond to the two DSM-5 symptom domains of autism spectrum disorder. Raw scores range from 65 to 260; higher scores indicate greater severity of social impairment.
Measured: Baseline, Weeks 8 and 17
Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs)
Participants experiencing at least one adverse event that newly appeared or worsened after treatment initiation. Adverse events are graded as mild, moderate, or severe; hospitalizations are documented as serious adverse events; causality is categorized from not related to definitely related.
Measured: Baseline to Week 17
Number of Participants With Clinically Significant Abnormal Laboratory Values
Number of participants with clinically significant abnormal values in complete blood count (CBC), liver transaminases, or total bilirubin levels, as determined by the investigator.
Measured: Week 8
Change From Baseline in Body Mass Index (BMI)
Difference between baseline and week 8 body mass index (kg/m²)
Measured: Baseline, Weeks 8 and 17
Clinical Global Impressions-Improvement (CGI-I) Score
CGI-I is a clinician rating of overall change from baseline; scores range from 1 to 7, with higher scores indicating worse outcome; anchors: 1 very much improved; 2 much improved; 3 minimally improved; 4 no change; 5 minimally worse; 6 much worse; 7 very much worse.
Measured: Weeks 8 and 17
Caregiver Global Impression of Change (CGIC or CaGC)
CGIC (CaGC) is a caregiver rating of overall change from baseline; scores range from 1 to 7, with higher scores indicating worse outcome; anchors: 1 very much improved; 2 much improved; 3 minimally improved; 4 no change; 5 minimally worse; 6 much worse; 7 very much worse.
Measured: Weeks 8 and 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start5 Oct 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion3 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bazelet Nehushtan LtD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Adi Aran, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07199218
- Sponsor's protocol ID
- 0336-24-SZMC
- Other IDs
- MOH_2025-04-21_014042
- Acronym
- TECA
- Status last verified
- Nov 2025
- First submitted
- 11 Sep 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that support the results of this trial will be made available to qualified researchers after study completion and publication of the primary results. Data will include baseline characteristics, outcome measures, and safety data. Supporting Information: Data will be shared beginning 12 months after publication and available for up to 5 years. Access will be granted upon submission of a methodologically sound proposal and approval by the principal investigator and institutional ethics committee. A data use agreement will be required to ensure protection of participant confidentiality. Supporting documents such as the study protocol and statistical analysis plan will also be available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Placebo-Controlled, Randomized, Double-Blind Study to Assess the Safety, Tolerability and Efficacy of Terpenes-enriched Cannabis Oil T1/C28, Administered to Pediatric Subjects With Autism Spectrum Disorder (ASD)
- ClinicalTrials.gov ID
- NCT07199218
- Acronym / sponsor ID
- TECA / 0336-24-SZMC
- Conditions
- Autism, Autism Spectrum Disorder
- Keywords
- autism, ASD, cannabidiol, terpenes, THC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Bazelet Nehushtan LtD.Industry (pharma, biotech, devices)
- Study start
- 5 Oct 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 3 Mar 2028 (estimated)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to determine whether cannabidiol (CBD, 28%) combined with terpenes and a small amount of THC (1%) can help reduce symptoms of autism, and to evaluate the safety of this treatment.
The main questions are:
- Does this treatment improve behavioral challenges in children with autism?
- Does this treatment improve social difficulties in children with autism?
What will happen in the study:
- Participants take either the study treatment or a placebo (a look-alike substance with no active drug) every day for 2 months.
- After 2 months, all participants receive the study treatment or a similar treatment without THC for another 2 months.
- Participants come to the clinic once every 2 months for checkups and tests.
Detailed description
Autism spectrum disorder (ASD) is a condition that affects communication, social interaction, and behavior. Current medications do not treat the core symptoms of autism, and the drugs sometimes prescribed (such as antipsychotics for irritability) can cause significant side effects.
Cannabidiol (CBD) is a natural, non-psychoactive compound from the cannabis plant that may reduce brain overactivity and inflammation. Tetrahydrocannabinol (THC), the psychoactive component of cannabis, acts on the endocannabinoid system, which is thought to function differently in people with autism. Research suggests that CBD combined with very small amounts of THC may improve behavior and social functioning. Other plant compounds called terpenes may enhance the effects of CBD and THC, even at low doses.
This study tests whether a CBD oil enriched with terpenes and a very small amount of THC is safe and effective for children with autism. Seventy-eight children, ages 4-13, will participate. Half will receive the study oil and half will receive a placebo (an inactive oil that looks the same) for 8 weeks. Afterward, all participants will receive an active treatment for another 8 weeks.
The study evaluates whether the treatment improves behavior, social skills, and quality of life. Safety is monitored through regular clinic visits, questionnaires, physical exams, and blood tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Terpenes-Enriched CBD-Predominant Oil | Experimental | Drug: Terpenes-Enriched CBD-Predominant OilOral cannabidiol (CBD), tetrahydrocannabinol (THC; 1/28 of the CBD dose), and terpenes, administered for 8 weeks as an add-on to existing treatments. After the first 8 weeks, participants will continue with the same treatment for an additional 8 weeks. |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Terpenes-Enriched CBD Oil (THC-Free)Oral olive oil with flavoring to mimic the texture and taste of the study drug, given for 8 weeks. After the first 8 weeks, participants will switch to terpenes-enriched CBD oil without THC for another 8 weeks. |
Who may qualify
- Ages
- 4 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 4 to 12 years (after the 4th birthday and before the 13th).
- Diagnosis of autism spectrum disorder (ASD) according to DSM-5, confirmed by Childhood Autism Rating Scale-Second Edition (CARS-2).
- Moderate or greater ASD-associated symptoms, defined as a rating of ≥4 ("moderate" or higher) on the Overall Function Clinical Global Impression-Severity (CGI-S).
- Aberrant Behavior Checklist-Irritability subscale (ABC-I) score ≥18.
- Social Responsiveness Scale-Second Edition (SRS-2) total T score ≥66.
Key exclusion criteria (8 listed)
- Body weight <12.5 kg or ≥57.5 kg.
- Current or past diagnosis of heart failure, drug addiction, schizophrenia, psychosis, bipolar disorder, post-traumatic stress disorder (PTSD), or major depressive disorder (MDD), or diagnosis of schizophrenia in a first-degree relative.
- Seizure or change in antiepileptic medications within 4 months prior to randomization.
- Clinically significant abnormalities on physical examination or laboratory testing, including impairment in cardiac, hepatic, or renal function.
- Change in pharmacological or behavioral treatment, or change in home or school environment (other than school holidays), within 4 weeks prior to randomization or planned during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Terpenes-Enriched CBD-Predominant OilOral cannabidiol (CBD; 7.2 mg/kg/day), tetrahydrocannabinol (THC; 0.257 mg/kg/day, equivalent to 1:28 of the CBD dose), and terpenes (0.5 mg/kg/day), administered in two daily doses. The formulation is an olive oil-based solution (CBD/THC: 280/10 mg per g) produced by Bazelet Group, Israel. | Drug | Terpenes-Enriched CBD-Predominant Oil |
| PlaceboOral olive oil with added flavors to mimic the appearance, texture, and taste of the study drug, administered in two daily doses. | Drug | Placebo |
| Terpenes-Enriched CBD Oil (THC-Free)Oral cannabidiol (CBD; 7.2 mg/kg/day) and terpenes (0.5 mg/kg/day), administered in two daily doses. The formulation is an olive oil-based solution (CBD- 280 mg per g) produced by Bazelet Group, Israel. | Drug | Placebo |
Primary outcome
Change From Baseline in Aberrant Behavior Checklist-Community (ABC-C): Irritability Subscale raw score (ABC-I)
Time frame: Baseline to Week 8
The ABC-C is a caregiver-completed questionnaire with 58 items, divided into five subscales. The ABC-I (Irritability) subscale includes 15 items that assess emotional and behavioral symptoms of ASD, such as aggression toward others, deliberate self-injury, temper tantrums, depressed mood, and rapidly shifting moods. Scores on this subscale range from 0 to 45, with higher scores indicating greater severity. Change from baseline to Week 8 is reported, with lower scores reflecting clinical improvement.
7 secondary outcomes
Change From Baseline in Vineland™-III Adaptive Behavior Scales (VABS3) Socialization Domain Standard Score
Time frame: Baseline to Week 8
Change From Baseline in Social Responsiveness Scale-2nd edition (SRS-II) total raw score
Time frame: Baseline, Weeks 8 and 17
Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs)
Time frame: Baseline to Week 17
Number of Participants With Clinically Significant Abnormal Laboratory Values
Time frame: Week 8
Change From Baseline in Body Mass Index (BMI)
Time frame: Baseline, Weeks 8 and 17
Clinical Global Impressions-Improvement (CGI-I) Score
Time frame: Weeks 8 and 17
Caregiver Global Impression of Change (CGIC or CaGC)
Time frame: Weeks 8 and 17
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that support the results of this trial will be made available to qualified researchers after study completion and publication of the primary results. Data will include baseline characteristics, outcome measures, and safety data. Supporting Information: Data will be shared beginning 12 months after publication and available for up to 5 years. Access will be granted upon submission of a methodologically sound proposal and approval by the principal investigator and institutional ethics committee. A data use agreement will be required to ensure protection of participant confidentiality. Supporting documents such as the study protocol and statistical analysis plan will also be available upon request.
Related trials for Autism
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Korenfine contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Terpenes-Enriched CBD-Predominant Oil and Terpenes-Enriched CBD Oil (THC-Free) in people with Autism and Autism Spectrum Disorder, run by Bazelet Nehushtan LtD. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adi Aran, MD (+97226555414, aaran@szmc.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Aberrant Behavior Checklist-Community (ABC-C): Irritability Subscale raw score (ABC-I) (time frame: Baseline to Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.