Cannabis UsePISCESNCT06588582
Perceptual Influences From Smoking Cannabis: an Experimental Study
A study testing Water Temperature Variation - WW and Water Temperature Variation - CW in people with Cannabis Use and Stress, run by University of Colorado, Boulder at 1 site in United States.
Trial summary
The purpose of the study is to better understand the effects of cannabis in relation to mental and physical states including its relationship with mood, cognition, perception including the experience of temperature and pain, and heart rate. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis Use, Stress
- What is being tested?
- Water Temperature Variation - WW and Water Temperature Variation - CW
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 166 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2025to 31 Jul 2029
- Phase
- Interventional
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 21-65 years of age
- Endorsement of at least some use of cannabis for coping purposes (>1 on CMMQ)
- Regularly use flower cannabis products (i.e., ≥1x/week in the last 6 months)
- Proficient in English language
- At least occasional use of CBD+THC or CBD-dominant products (e.g., ≥1x/month)
Who cannot join
- Diagnosis or use of medications for substance use or psychotic disorders
- Report of other drug use (cocaine, opiates, methamphetamine) in the past 90 days or fail urine screen for any of these drugs
- Females cannot be pregnant or trying to become pregnant or nursing mothers
- Not able to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado at Boulder
Boulder, Colorado, 80309
Carillon Skrzynski, PhD, (734)788-2961, carillon.skrzynski@colorado.edu
About this study
Official title: Exploring the Antecedents and Consequences of Cannabis Use in the Context of Coping: An Experimental Study
The purpose of the study is to better understand the effects of cannabis in relation to mental and physical states including its relationship with mood, cognition, perception including the experience of temperature and pain, and heart rate.
We expect that participants will be in this research study for approximately one week. The total amount of time that participants will spend completing study tasks will be about 2.5 hours across two separate in-person visits.
- Conditions
- Cannabis Use, Stress
- Being tested
- Water Temperature Variation - WW, Water Temperature Variation - CW
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water Temperature Variation - WWOther
Participants are assigned to warm water temperature.
Water Temperature Variation - CWOther
Participants are assigned to cold water temperature and are video recorded.
| Study group | Role | What they receive |
|---|---|---|
| Cold Water | Experimental | Not described Receives: Other: Water Temperature Variation - CW |
| Warm Water | Placebo comparator | Not described Receives: Other: Water Temperature Variation - WW |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Cortisol Levels
Cortisol levels are measured in blood.
Measured: Pre-Use/Pre-Water Task, 20 minutes Post-Use, 40 minutes Post-Use
Cannabis Used
Grams of product used is calculated. Product is measured before and after use to measure how much was used.
Measured: Immediate Post-Use
Blood Endocannabinoid Levels
Blood levels of AEA are measured.
Measured: Pre-Use/Pre-Water Task, 20 minutes Post-Use
Heart Rate
Participant HR is measured via pulse oximeter.
Measured: Pre-Use/Pre-Water Task, Pre-Use/Post-Water Task, 20 minutes Post-Use
Social Anxiety
Social Interaction Anxiety Scale (SIAS). 20 item survey, questions are answered on scale of 0 (not at all) to 4 (extremely), with higher scores indicating higher social anxiety. Questions are summed, with higher overall scores indicating higher social anxiety.
Measured: Pre-Use/Pre-Water Task
Inhibitory Control
Go/No-go Task. Participants are asked to complete a cognitive task where they see the text "Go" or "No go" during different trials. When they see "Go", they need to push a button within 2 seconds. When they see "No-go", they need to make sure they do not press the button (for 2 seconds). This is a measure of impulsivity.
Measured: Baseline
Stress
Stress Subscale of Depression and Anxiety Stress Scale measures stress. On scale from 0 (does not apply to me at all) to 3 (apply to me very much or most of the time). Higher scores indicate higher stress levels.
Measured: Pre-Use/Pre-Water Task
Blood cannabinoid levels
THC and CBD blood levels are measured.
Measured: Pre-Use/Pre-Water Task, 20 minutes Post-Use
Current Pain
Internal scale/measure, measured from 0 (no pain) to 10 (worst pain imaginable). Participants report current pain on this self-report scale.
Measured: Pre-Use/Pre-Water Task, Pre-Use/Post-Water Task, 20 minutes Post-Use, 40 minutes Post-Use
Mood
Profile of Mood States (POMS). Focus on the stress, anxiety, tension, and relaxation questions (combined for a tension/anxiety subscale). Questions are on a scale 1 (not at all) to 5 (extremely). Scores are summed, with higher scores indicating more tension/anxiety.
Measured: Pre-Use/Pre-Water Task, Pre-Use/Post-Water Task, 20 minutes Post-Use, 40 minutes Post-Use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start17 Feb 2025
- Primary completion1 Jul 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis UseStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Carillon Skrzynski, University of Colorado, Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06588582
- Sponsor's protocol ID
- 23-03-0215
- Other IDs
- 1K01DA058152-01A1
- Acronym
- PISCES
- Status last verified
- Jun 2025
- First submitted
- 6 Sep 2024
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Antecedents and Consequences of Cannabis Use in the Context of Coping: An Experimental Study
- ClinicalTrials.gov ID
- NCT06588582
- Acronym / sponsor ID
- PISCES / 23-03-0215
- Conditions
- Cannabis Use, Stress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 19 Sep 2024 (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 the study is to better understand the effects of cannabis in relation to mental and physical states including its relationship with mood, cognition, perception including the experience of temperature and pain, and heart rate.
We expect that participants will be in this research study for approximately one week. The total amount of time that participants will spend completing study tasks will be about 2.5 hours across two separate in-person visits.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cold Water | Experimental | Other: Water Temperature Variation - CW |
| Warm Water | Placebo comparator | Other: Water Temperature Variation - WW |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 21-65 years of age
- Endorsement of at least some use of cannabis for coping purposes (>1 on CMMQ)
- Regularly use flower cannabis products (i.e., ≥1x/week in the last 6 months)
- Proficient in English language
- At least occasional use of CBD+THC or CBD-dominant products (e.g., ≥1x/month)
Key exclusion criteria (4 listed)
- Diagnosis or use of medications for substance use or psychotic disorders
- Report of other drug use (cocaine, opiates, methamphetamine) in the past 90 days or fail urine screen for any of these drugs
- Females cannot be pregnant or trying to become pregnant or nursing mothers
- Not able to provide informed consent
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 |
|---|---|---|
| Water Temperature Variation - WWParticipants are assigned to warm water temperature. | Other | Warm Water |
| Water Temperature Variation - CWParticipants are assigned to cold water temperature and are video recorded. | Other | Cold Water |
Primary outcome
Blood Cortisol Levels
Time frame: Pre-Use/Pre-Water Task, 20 minutes Post-Use, 40 minutes Post-Use
Cortisol levels are measured in blood.
Cannabis Used
Time frame: Immediate Post-Use
Grams of product used is calculated. Product is measured before and after use to measure how much was used.
Blood Endocannabinoid Levels
Time frame: Pre-Use/Pre-Water Task, 20 minutes Post-Use
Blood levels of AEA are measured.
Heart Rate
Time frame: Pre-Use/Pre-Water Task, Pre-Use/Post-Water Task, 20 minutes Post-Use
Participant HR is measured via pulse oximeter.
Social Anxiety
Time frame: Pre-Use/Pre-Water Task
Social Interaction Anxiety Scale (SIAS). 20 item survey, questions are answered on scale of 0 (not at all) to 4 (extremely), with higher scores indicating higher social anxiety. Questions are summed, with higher overall scores indicating higher social anxiety.
Inhibitory Control
Time frame: Baseline
Go/No-go Task. Participants are asked to complete a cognitive task where they see the text "Go" or "No go" during different trials. When they see "Go", they need to push a button within 2 seconds. When they see "No-go", they need to make sure they do not press the button (for 2 seconds). This is a measure of impulsivity.
Stress
Time frame: Pre-Use/Pre-Water Task
Stress Subscale of Depression and Anxiety Stress Scale measures stress. On scale from 0 (does not apply to me at all) to 3 (apply to me very much or most of the time). Higher scores indicate higher stress levels.
Blood cannabinoid levels
Time frame: Pre-Use/Pre-Water Task, 20 minutes Post-Use
THC and CBD blood levels are measured.
Current Pain
Time frame: Pre-Use/Pre-Water Task, Pre-Use/Post-Water Task, 20 minutes Post-Use, 40 minutes Post-Use
Internal scale/measure, measured from 0 (no pain) to 10 (worst pain imaginable). Participants report current pain on this self-report scale.
Mood
Time frame: Pre-Use/Pre-Water Task, Pre-Use/Post-Water Task, 20 minutes Post-Use, 40 minutes Post-Use
Profile of Mood States (POMS). Focus on the stress, anxiety, tension, and relaxation questions (combined for a tension/anxiety subscale). Questions are on a scale 1 (not at all) to 5 (extremely). Scores are summed, with higher scores indicating more tension/anxiety.
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 13 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water Temperature Variation - WW and Water Temperature Variation - CW in people with Cannabis Use and Stress, run by University of Colorado, Boulder 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 5 inclusion and 4 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 13 Jun 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 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.
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 Carillon Skrzynski, PhD ((734)788-2961, carillon.skrzynski@colorado.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Cortisol Levels (time frame: Pre-Use/Pre-Water Task, 20 minutes Post-Use, 40 minutes Post-Use). The study lists 10 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 13 Jun 2025.