HealthyPhase 1CAPU RISENCT05261321
Cannabis and Polysubstance Use: Response Inhibition and Stress Exposure
A Phase 1 study testing Cannabis oil with a high ratio of THC to CBD and Cannabis oil with a high ratio of CBD to THC in people with Healthy, run by University of British Columbia at 1 site in Canada.
Trial summary
The purpose of this Phase I non-therapeutic trial is to examine the neurological effects of cannabis on stress reactivity and inhibition in healthy cannabis users. We expect differences between high ratio CBD:THC cannabis oil, low ratio CBD:THC cannabis oil, and/or placebo on outcome measures. Read more about this study
- Who is it for?
- Ages 19 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cannabis oil with a high ratio of THC to CBD and Cannabis oil with a high ratio of CBD to THC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 15 Oct 2022to Mar 2026
- Phase
- Phase 1
- 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 19 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Are 19-35 years old at the start of the study
- Have used oral cannabis, including at least 5mg of THC, at least once in their life
- Have used cannabis at least once in the past year
- Used cannabis less than 3 times per week on average, in the past 3 months
- Are using an effective and/or highly effective method of contraception and will continue to do so for the duration of participation in the study. Health Canada's definition of effective methods of contraception include barrier methods of contraception (e.g. male condom, female condom, cervical cap, diaphragm, contraceptive sponge). Health Canada's definition of highly effective methods of contraception includes hormonal contraceptives (e.g. combined oral contraceptives, patch, vaginal ring, injectables, and implants); intrauterine device (IUD) or intrauterine system (IUS); vasectomy and tubal ligation.
- Females: are not undergoing alternative fertility methods, such as IVF, or otherwise trying to start a family for the duration of participation
Show all 11Show fewer
- Males: will not be donating sperm at some point during the duration of participation
- Are able to provide informed consent
- Are able to complete assessments in English
- Are able to attend sessions according to the study schedule
- Will provide proof of 2 doses of an approved COVID-19 vaccination
Who cannot join
- Are left-handed or ambidextrous
- Females: are pregnant, nursing, or not on safe pregnancy protection
- Are trying to conceive
- Have a known or suspected allergy to cannabinoids and/or palm/coconut oil
- Are hypersensitive to CBD and/or THC and/or have ever had an adverse reaction (an unwanted and unexpected reaction), to less than 40mg of CBD and/or 10mg THC
- Have had an adverse reaction (unwanted, unexpected reaction or symptoms) to cannabis within last 6 months
Show all 46Show fewer
- Have a major physical problem/health concern, including:
- Liver-cirrhosis or other liver disease
- Diabetes
- Chronic illness that may increase risk for adverse reactions to cannabis
- Chronic pain
- Genetic glucuronidation disorders (e.g., Gilbert's disease)
- Cardiovascular disease, including ischemic heart disease with unstable angina or recent acute coronary syndrome in the last 3 months, uncontrolled arrhythmias, poorly controlled hypertension or high blood pressure (e.g., 130/80), or severe heart failure
- Delirium: active delirium or recent delirium < 7 days, or at significant risk of delirium due to multiple comorbidities (e.g., very elderly, cognitive impairment, cerebrovascular disease) and contributing drugs (e.g., alcohol, stimulants, high doses of benzodiazepines, opioid, sedatives, psychoactive medications)
- Are taking any of the following medications:
- Any medication that impacts the central nervous system, brain, and/or metabolic system
- Psychotropic medications, sedatives, and central nervous system depressants, including sleeping pills, tranquilizers, some pain medications, some allergy and cold medications, and anti-seizure medications
- Medications otherwise affecting the central nervous system, including amphetamines and other sympathomimetics
- Allergy medications (antihistamines; within 24 hours)
- Heart medications
- Blood pressure medication
- Steroid medications
- Opioids or other pain medications
- Anticholinergics: drugs that block acetylcholine, a chemical signal that plays a role in memory and learning.
- Drugs metabolized by cytochrome P450 enzymes, including amitriptyline, fentanyl, sufentanil, and alfentanil
- Highly protein-bound drugs, including warfarin, cyclosporine, and amphtericin
- Drugs metabolized by UGT enzymes, including propofol, antivirals
- Antiretroviral drugs
- Stomach acid inhibitors
- Antibiotics and antifungal medications
- Heart medications
- Other medications/substances interfering with CYP2C19 receptors
- Inhibitors: Fluvoxamine, isoniazid (INH), ritonavir ii. Inducers: Carbamazepine, phenytoin, rifampin iii. Substrates: Omeprazole (Prilosec), phenobarbital, phenytoin r. Other medications/substances interfering with CYP3A4 receptors: i. Inhibitors: Clarithromycin (Biaxin), diltiazem (Cardizem), erythromycin, grapefruit juice, itraconazole (Sporanox), ketoconazole (Nizoral), nefazodone (Serzone), ritonavir, telithromycin (Ketek), verapamil (Calan) ii. Inducers: Carbamazepine, Hypericum perforatum (St. John's wort), phenobarbital, phenytoin, rifampin iii. Substrates: Alprazolam (Xanax), amlodipine (Norvasc), atorvastatin (Lipitor), cyclosporine (Sandimmune), diazepam (Valium), estradiol (Estrace), simvastatin (Zocor), sildenafil (Viagra), verapamil, zolpidem (Ambien)
- Other MRI contraindications (conditions that make MRI procedure inadvisable):
- Have implanted metal clips or wires, including: i. Implanted electronic device (e.g., pacemaker, defibrillator implanted medication infusion pump, electrical stimulator, and/or ear or eye implant) including retained wires that has been removed (e.g., pacemaker wires not attached to a pacemaker) ii. Stainless steel intrauterine device (IUD) iii. Metal in eye or orbit, or metal slivers iv. Ferromagnetic aneurysm clip v. Coil, catheter, or filter in any blood vessel vi. Orthopedic hardware (artificial joint, plate, screw, rod) vii. Shrapnel, bullets, or other metal fragments (i.e., metal in eye or orbit) viii. Artificial heart valve ix. Ear or eye implant x. Brain aneurysm clip xi. Implanted electronic device (i.e., drug infusion pump, electrical stimulator) xii. Coil, catheter, or filter in any blood vessel xiii. Surgery, medical procedure or tattoos (including tattooed eyeliner) in the last six weeks xiv. Other metallic prostheses b. Have a personal or family history of seizures c. Have any significant neurological disorder including, but not limited to: i. Any condition likely to be associated with increased intracranial pressure ii. Space-occupying brain lesion iii. Seizure iv. Cerebral aneurysm v. Parkinson's disease vi. Huntington's chorea vii. Multiple sclerosis viii. Significant head trauma with loss of consciousness for greater than or equal to 5 minutes d. Claustrophobia (i.e., feel uncomfortable in small spaces) or fear of loud, repetitive sounds, or inability to lay still. Participants will have to lie still in the confined space of the MRI scanner.
- Work nightshifts
- Have any diagnosed sleep disorders
- Have dyscalculia
- Have a neurodevelopmental disorder or cognitive impairments, including:
- Autism Spectrum Disorder
- Attention Deficit/Hyperactivity Disorder (ADHD)
- Have schizophrenia spectrum disorder and/or history of psychosis
- Meet criteria for potential mental health disorder in the Mini International Neuropsychiatric Interview (M.I.N.I.) Screen Version 7.0.2, except for alcohol and cannabis use disorders
- Any diagnosed current mental health disorder and/or diagnosis of a mental health disorder within the past year
- Have a non-correctable clinically significant sensory impairment (e.g., cannot hear well enough to cooperate with interview)
- 19) Are unable to attend sessions according to the study schedule 20) Have used opiates more than twice in the past 30 days
Trial locations and contacts
1 site in 1 country.
Canada1 site
B.R.A.I.N. Lab, Institute of Mental Health, Faculty of Medicine, University of British Columbia
Vancouver, British Columbia, V6T 1Z3
About this study
The purpose of this Phase I non-therapeutic trial is to examine the neurological effects of cannabis on stress reactivity and inhibition in healthy cannabis users. We expect differences between high ratio CBD:THC cannabis oil, low ratio CBD:THC cannabis oil, and/or placebo on outcome measures.
Read the detailed description
Purpose: To examine the neurological effects of cannabis on stress reactivity and inhibition in healthy adults using recreational cannabis. This is a phase I/pilot healthy subjects trial.
Primary Hypotheses:
- The intervention will be feasible to implement
- Cannabis oil will attenuate stress, measured via biological and self-report data, including salivary molecules, functional Magnetic Resonance Imaging, and standardized psychosocial assessments.
Justification: Current cannabis research focuses on medical uses for cannabis, clinical populations and/or non-commercially available products. There remains limited experimental research on the effects of commercial products in non-clinical regular users of cannabis. Further, most drug use research excludes polysubstance users. Given the high number of people using cannabis to cope with stress, biological evidence is needed to determine the validity of this claim. Stress is known to negatively impact daily functioning and has been linked to poorer mental and physical health outcomes. The effects of cannabinoids on cognitive functioning also have implications for daily functioning.
Objectives: Determine a causal link between commercially available cannabinoid products and mechanisms involved with stress response in polysubstance users, specifically weekly cannabis users with heavy drinking (males: minimum 5 drinks, females: minimum 4 drinks on at least one occasional per month for the past 12 months). Examine the short-term effects of cannabinoids on sleep quality in this population.
Study Design: The study is a Phase I non-therapeutic pilot trial and will utilize a double-blind, placebo-controlled, within-subjects design. The acute effects of the investigational products (IPs) will be examined. Each participant will undergo an initial phone screen and 5 sessions, with sessions 2-4 involving drug administration. There will be three investigational product arms for the drug administration sessions: cannabis oil with a high ratio of THC to CBD, cannabis oil with a high ratio of CBD to THC, and placebo. Each participant will be exposed to all three arms, one per drug administration session. The order of arm will be randomized. Each drug administration session will be a minimum of10 days apart to ensure a sufficient washout period.
- Conditions
- Healthy
- Being tested
- Cannabis oil with a high ratio of THC to CBD, Cannabis oil with a high ratio of CBD to THC, Placebo
- Keywords
- cannabis, cannabinoids, stress, neuroimaging, fMRI
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabis oil with a high ratio of THC to CBDDrug
In the first active condition, cannabis oil with a high THC to CBD ratio will be administered to participants.
Cannabis oil with a high ratio of CBD to THCDrug
In the second active condition, cannabis oil with a high CBD to THC ratio will be administered to participants.
PlaceboDrug
In the control condition, the placebo will be administered to participants.
| Study group | Role | What they receive |
|---|---|---|
| Cannabis oil with a high ratio of THC to CBD | Active comparator | Participants will be given a single dose of oral cannabis oil containing 5mg THC and 0.17mg CBD. Receives: Drug: Cannabis oil with a high ratio of THC to CBD |
| Cannabis oil with a high ratio of CBD to THC | Active comparator | Participants will be given a single dose of oral cannabis oil containing 5mg THC and 25mg CBD. Receives: Drug: Cannabis oil with a high ratio of CBD to THC |
| Placebo | Placebo comparator | Participants will be given a single dose of 1 mL placebo (carrier oil with botanical terpenes) via oral route of administration. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in stress response across conditions
Indicated by differences in blood-oxygenation-level-imaging (BOLD) response via functional magnetic resonance imaging (fMRI), salivary stress molecule levels (eg cortisol, IgA), heart rate, and self-reports. Participants will fill out a daily diary each morning starting the day after session 1 until the day of session 5 with their self-reports.
Measured: 5 weeks
Change in incidence of adverse events of cannabinoids across conditions
Assessed through self-reports from study participants (semi-structured interviews) and clinically significant adverse changes in vital signs (heart rate, blood pressure).
Measured: 5 weeks
Procedure feasibility
Measured via means and rates of study recruitment
Measured: Through study completion; average of 1 year
Protocol feasibility
Measured via means and rates of study recruitment
Measured: Through study completion; average of 1 year
Secondary outcomes (5)
Change in performance on behavioral impulsivity tasks across conditions
Measured by Delay and Probability Discounting Procedure, Experiential Discounting Task, and the Hybrid Response Inhibition Task
Measured: 5 weeks
Change in sleep quality across conditions
Measured via wrist-worn actigraphy using the Fatigue Science Readiband and self-report based on the Pittsburgh Sleep Inventory
Measured: 5 weeks
Change in subjective response to cannabis
Measured via Drug Effects Questionnaire, assessing aspects of subjective response on a scale from "Not at All" to "Extremely", "Dislike Very Much" to "Like Very Much", and other variations.
Measured: 5 weeks
Change in state anxiety across conditions
Measured by State Anxiety sub-scale of the State Trait Anxiety sub-scale, rating experience from "Not at All" to "Very Much"
Measured: 5 weeks
Change in psychological distress across conditions
Measured by the standardized Short Form of the Profile of Mood States, assessing experience of various feelings from "Not at All" to "Extremely"
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start15 Oct 2022
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Schutz, University of British Columbia
- Investigators
- Christian G Schütz, MD PhD, Principal investigator, University of British Columbia; British Columbia Mental Health and Substance Use ServicesKarina A Thiessen, BA BEd, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05261321
- Sponsor's protocol ID
- CAPU RISE 1.0
- Acronym
- CAPU RISE
- Status last verified
- Feb 2026
- First submitted
- 25 Jan 2022
- Last updated
- 3 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabis and Polysubstance Use: Response Inhibition and Stress Exposure
- ClinicalTrials.gov ID
- NCT05261321
- Acronym / sponsor ID
- CAPU RISE / CAPU RISE 1.0
- Conditions
- Healthy
- Keywords
- cannabis, cannabinoids, stress, neuroimaging, fMRI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 2 Mar 2022 (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 purpose of this Phase I non-therapeutic trial is to examine the neurological effects of cannabis on stress reactivity and inhibition in healthy cannabis users. We expect differences between high ratio CBD:THC cannabis oil, low ratio CBD:THC cannabis oil, and/or placebo on outcome measures.
Detailed description
Purpose: To examine the neurological effects of cannabis on stress reactivity and inhibition in healthy adults using recreational cannabis. This is a phase I/pilot healthy subjects trial.
Primary Hypotheses:
- The intervention will be feasible to implement
- Cannabis oil will attenuate stress, measured via biological and self-report data, including salivary molecules, functional Magnetic Resonance Imaging, and standardized psychosocial assessments.
Justification: Current cannabis research focuses on medical uses for cannabis, clinical populations and/or non-commercially available products. There remains limited experimental research on the effects of commercial products in non-clinical regular users of cannabis. Further, most drug use research excludes polysubstance users. Given the high number of people using cannabis to cope with stress, biological evidence is needed to determine the validity of this claim. Stress is known to negatively impact daily functioning and has been linked to poorer mental and physical health outcomes. The effects of cannabinoids on cognitive functioning also have implications for daily functioning.
Objectives: Determine a causal link between commercially available cannabinoid products and mechanisms involved with stress response in polysubstance users, specifically weekly cannabis users with heavy drinking (males: minimum 5 drinks, females: minimum 4 drinks on at least one occasional per month for the past 12 months). Examine the short-term effects of cannabinoids on sleep quality in this population.
Study Design: The study is a Phase I non-therapeutic pilot trial and will utilize a double-blind, placebo-controlled, within-subjects design. The acute effects of the investigational products (IPs) will be examined. Each participant will undergo an initial phone screen and 5 sessions, with sessions 2-4 involving drug administration. There will be three investigational product arms for the drug administration sessions: cannabis oil with a high ratio of THC to CBD, cannabis oil with a high ratio of CBD to THC, and placebo. Each participant will be exposed to all three arms, one per drug administration session. The order of arm will be randomized. Each drug administration session will be a minimum of10 days apart to ensure a sufficient washout period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cannabis oil with a high ratio of THC to CBD | Active comparator | Drug: Cannabis oil with a high ratio of THC to CBDParticipants will be given a single dose of oral cannabis oil containing 5mg THC and 0.17mg CBD. |
| Cannabis oil with a high ratio of CBD to THC | Active comparator | Drug: Cannabis oil with a high ratio of CBD to THCParticipants will be given a single dose of oral cannabis oil containing 5mg THC and 25mg CBD. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will be given a single dose of 1 mL placebo (carrier oil with botanical terpenes) via oral route of administration. |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Are 19-35 years old at the start of the study
- Have used oral cannabis, including at least 5mg of THC, at least once in their life
- Have used cannabis at least once in the past year
- Used cannabis less than 3 times per week on average, in the past 3 months
- Are using an effective and/or highly effective method of contraception and will continue to do so for the duration of participation in the study. Health Canada's definition of effective methods of contraception include barrier methods of contraception (e.g. male condom, female condom, cervical cap, diaphragm, contraceptive sponge). Health Canada's definition of highly effective methods of contraception includes hormonal contraceptives (e.g. combined oral contraceptives, patch, vaginal ring, injectables, and implants); intrauterine device (IUD) or intrauterine system (IUS); vasectomy and tubal ligation.
Key exclusion criteria (46 listed)
- Are left-handed or ambidextrous
- Females: are pregnant, nursing, or not on safe pregnancy protection
- Are trying to conceive
- Have a known or suspected allergy to cannabinoids and/or palm/coconut oil
- Are hypersensitive to CBD and/or THC and/or have ever had an adverse reaction (an unwanted and unexpected reaction), to less than 40mg of CBD and/or 10mg THC
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 |
|---|---|---|
| Cannabis oil with a high ratio of THC to CBDIn the first active condition, cannabis oil with a high THC to CBD ratio will be administered to participants. | Drug | Cannabis oil with a high ratio of THC to CBD |
| Cannabis oil with a high ratio of CBD to THCIn the second active condition, cannabis oil with a high CBD to THC ratio will be administered to participants. | Drug | Cannabis oil with a high ratio of CBD to THC |
| PlaceboIn the control condition, the placebo will be administered to participants. | Drug | Placebo |
Primary outcome
Change in stress response across conditions
Time frame: 5 weeks
Indicated by differences in blood-oxygenation-level-imaging (BOLD) response via functional magnetic resonance imaging (fMRI), salivary stress molecule levels (eg cortisol, IgA), heart rate, and self-reports. Participants will fill out a daily diary each morning starting the day after session 1 until the day of session 5 with their self-reports.
Change in incidence of adverse events of cannabinoids across conditions
Time frame: 5 weeks
Assessed through self-reports from study participants (semi-structured interviews) and clinically significant adverse changes in vital signs (heart rate, blood pressure).
Procedure feasibility
Time frame: Through study completion; average of 1 year
Measured via means and rates of study recruitment
Protocol feasibility
Time frame: Through study completion; average of 1 year
Measured via means and rates of study recruitment
5 secondary outcomes
Change in performance on behavioral impulsivity tasks across conditions
Time frame: 5 weeks
Change in sleep quality across conditions
Time frame: 5 weeks
Change in subjective response to cannabis
Time frame: 5 weeks
Change in state anxiety across conditions
Time frame: 5 weeks
Change in psychological distress across conditions
Time frame: 5 weeks
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 3 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Healthy
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
RecruitingObservational study
Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders
Mood Disorders, Anxiety Disorders
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Not yet recruiting
Evaluating the Healthy Families PrEP Program for Women at Risk for HIV
HIV, Pregnancy
RecruitingPhase 1
A Single Ascending Dose Study of DTI-117 Given Intramuscularly in Healthy Participants.
Healthy Adult
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. This study is not recruiting at the moment.
Christian G Schütz, MD PhD principal investigator
University of British Columbia; British Columbia Mental Health and Substance Use Services
Karina A Thiessen, BA BEd study director
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cannabis oil with a high ratio of THC to CBD and Cannabis oil with a high ratio of CBD to THC in people with Healthy, run by University of British Columbia at 1 site in Canada.
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 11 inclusion and 46 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: under way, not looking for participants, as of the sponsor's last update on 3 Mar 2026. 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 Canada. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in stress response across conditions (time frame: 5 weeks). The study lists 4 primary outcomes in all. 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 3 Mar 2026.