Delta-9-tetrahydrocannabinol (THC)Early Phase 1ETSNCT06471647
Effects of Drugs on Stress Memories
A Early Phase 1 study testing delta-9-tetrahydrocannabinol (THC) (5) and delta-9-tetrahydrocannabinol (THC) (10) in people with Delta-9-tetrahydrocannabinol (THC) and Stress, run by University of Chicago at 1 site in United States.
Trial summary
There is evidence that cannabinoids, including delta-9-tetrahydrocannabinol (THC), reduce responses to acute stress and fear-related stimuli, but few studies have examined the effects of THC on memories of stressful experiences. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Delta-9-tetrahydrocannabinol (THC), Stress
- What is being tested?
- delta-9-tetrahydrocannabinol (THC) (5) and delta-9-tetrahydrocannabinol (THC) (10)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 25 Mar 2025
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-35 y/o
- BMI 19-29 kg/m2
- some prior experience with cannabis (used at least 4 times, no adverse experiences, and current use no more than once a week)
Who cannot join
- Current severe substance use disorder
- history of psychosis or mania
- Lack of English fluency
- Current DSM IV Axis I disorder
- Abnormal EKG
- Daily use of medications outside of contraception,
- Women who are pregnant or trying to become pregnant
Trial locations and contacts
1 site in 1 country.
About this study
There is evidence that cannabinoids, including delta-9-tetrahydrocannabinol (THC), reduce responses to acute stress and fear-related stimuli, but few studies have examined the effects of THC on memories of stressful experiences. The researchers hypothesize that THC will attenuate behavioral and physiological responses to negative valence stimuli, including memories of aversive experiences.
Read the detailed description
The current study will use a between subject, randomized, placebo-controlled design to assess the effects of low doses of delta-9-tetrahydrocannabinol (THC) on stress memories. Healthy male and female participants (N=48) will be randomly assigned to one of the three drug conditions (5 mg THC [n=16], 10 mg THC [n=16], or placebo [n=16]). Each subject will participate in 3 sessions. In the first session, they will undergo the TSST procedure. Researchers will obtain ratings of subjective distress, heart rate variability, and cortisol levels to assess response to the stressor for each individual. On the second session, one week later, participants will receive either THC or placebo and they will then be presented with TSST-related cues during a stress-memory retrieval session.
- Conditions
- Delta-9-tetrahydrocannabinol (THC), Stress
- Being tested
- delta-9-tetrahydrocannabinol (THC) (5), Placebo, delta-9-tetrahydrocannabinol (THC) (10)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
delta-9-tetrahydrocannabinol (THC) (5)Drug
5 mg of THC
PlaceboDrug
Placebo - dextrose
delta-9-tetrahydrocannabinol (THC) (10)Drug
10 mg of THC
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Dextrose capsules Receives: Drug: Placebo |
| 5 mg delta-9-tetrahydrocannabinol (THC) | Experimental | Marinol (dronabinol) Receives: Drug: delta-9-tetrahydrocannabinol (THC) (5) |
| 10 mg delta-9-tetrahydrocannabinol (THC) | Experimental | Marinol (dronabinol) Receives: Drug: delta-9-tetrahydrocannabinol (THC) (10) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotional Responses After Stress Memory Cues Compared to Control Cues After Delta-9-tetrahydrocannabinol (THC) (5 mg, 10 mg) vs. Placebo
Using a visual analog scale participants will rate feelings of 'distress' 'arousal' and 'valence'. Scores range from 0-100 with higher scores indicating greater responses on particular items
Measured: 20 seconds after each cue presentation during the task
Mean Physiological Responses After Stress Memory Cue Presentation Compared to Control Cues
Researchers will assess changes in cardiac output (pre-ejection period) after presentation of cues. This will be measured in milliseconds. Lower values indicate greater sympathetic activation.
Measured: difference between values during 20 seconds of task cue presentations
Secondary outcomes (2)
Mean Emotional Responses One Week Later During Non-drug Retrieval Session
Using a visual analog scale from 0-100 participants will rate feelings of 'distress' 'arousal' and 'valence' in a non-drug state. Scores range from 0-100 with higher scores indicating greater responses on particular items
Measured: 1 week after the first exposure they will complete the memory task again. The timeframe for assessing mean emotional responses will be at baseline (5 minutes pre-memory task) and 20 seconds after each cue presentation
Mean Negative Facial Emotion Expressions During Cue Presentation After THC (5 and 10 mg) vs Placebo
Using facial expression model, researchers will assess changes in the intensity (0-1) of negative facial emotions during presentation of memory cues, comparing control vs. stress memory cues. higher values indicate greater intensity.
Measured: During 20 seconds cue presentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start1 Jul 2024
- Primary completion25 Mar 2025
- Study completion25 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Delta-9-tetrahydrocannabinol (THC)Studies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harriet de Wit, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471647
- Sponsor's protocol ID
- IRB23-1534
- Acronym
- ETS
- Status last verified
- Jul 2026
- First submitted
- 12 Jun 2024
- Last updated
- 9 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Drugs on Stress Memories
- ClinicalTrials.gov ID
- NCT06471647
- Acronym / sponsor ID
- ETS / IRB23-1534
- Conditions
- Delta-9-tetrahydrocannabinol (THC), Stress
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 25 Mar 2025 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 24 Jun 2024 (actual)
- Results
- Posted 9 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is evidence that cannabinoids, including delta-9-tetrahydrocannabinol (THC), reduce responses to acute stress and fear-related stimuli, but few studies have examined the effects of THC on memories of stressful experiences. The researchers hypothesize that THC will attenuate behavioral and physiological responses to negative valence stimuli, including memories of aversive experiences.
Detailed description
The current study will use a between subject, randomized, placebo-controlled design to assess the effects of low doses of delta-9-tetrahydrocannabinol (THC) on stress memories. Healthy male and female participants (N=48) will be randomly assigned to one of the three drug conditions (5 mg THC [n=16], 10 mg THC [n=16], or placebo [n=16]). Each subject will participate in 3 sessions. In the first session, they will undergo the TSST procedure. Researchers will obtain ratings of subjective distress, heart rate variability, and cortisol levels to assess response to the stressor for each individual. On the second session, one week later, participants will receive either THC or placebo and they will then be presented with TSST-related cues during a stress-memory retrieval session.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: PlaceboDextrose capsules |
| 5 mg delta-9-tetrahydrocannabinol (THC) | Experimental | Drug: delta-9-tetrahydrocannabinol (THC) (5)Marinol (dronabinol) |
| 10 mg delta-9-tetrahydrocannabinol (THC) | Experimental | Drug: delta-9-tetrahydrocannabinol (THC) (10)Marinol (dronabinol) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-35 y/o
- BMI 19-29 kg/m2
- some prior experience with cannabis (used at least 4 times, no adverse experiences, and current use no more than once a week)
Key exclusion criteria (7 listed)
- Current severe substance use disorder
- history of psychosis or mania
- Lack of English fluency
- Current DSM IV Axis I disorder
- Abnormal EKG
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 |
|---|---|---|
| delta-9-tetrahydrocannabinol (THC) (5)5 mg of THC | Drug | 5 mg delta-9-tetrahydrocannabinol (THC) |
| PlaceboPlacebo - dextrose | Drug | placebo |
| delta-9-tetrahydrocannabinol (THC) (10)10 mg of THC | Drug | 10 mg delta-9-tetrahydrocannabinol (THC) |
Primary outcome
Emotional Responses After Stress Memory Cues Compared to Control Cues After Delta-9-tetrahydrocannabinol (THC) (5 mg, 10 mg) vs. Placebo
Time frame: 20 seconds after each cue presentation during the task
Using a visual analog scale participants will rate feelings of 'distress' 'arousal' and 'valence'. Scores range from 0-100 with higher scores indicating greater responses on particular items
Mean Physiological Responses After Stress Memory Cue Presentation Compared to Control Cues
Time frame: difference between values during 20 seconds of task cue presentations
Researchers will assess changes in cardiac output (pre-ejection period) after presentation of cues. This will be measured in milliseconds. Lower values indicate greater sympathetic activation.
2 secondary outcomes
Mean Emotional Responses One Week Later During Non-drug Retrieval Session
Time frame: 1 week after the first exposure they will complete the memory task again. The timeframe for assessing mean emotional responses will be at baseline (5 minutes pre-memory task) and 20 seconds after each cue presentation
Mean Negative Facial Emotion Expressions During Cue Presentation After THC (5 and 10 mg) vs Placebo
Time frame: During 20 seconds cue presentation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Harriet de Wit principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing delta-9-tetrahydrocannabinol (THC) (5) and delta-9-tetrahydrocannabinol (THC) (10) in people with Delta-9-tetrahydrocannabinol (THC) and Stress, run by University of Chicago at 1 site in United States.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 9 Jul 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 United States. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Emotional Responses After Stress Memory Cues Compared to Control Cues After Delta-9-tetrahydrocannabinol (THC) (5 mg, 10 mg) vs. Placebo (time frame: 20 seconds after each cue presentation during the task). The study lists 2 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 9 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.