- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06588582
Perceptual Influences From Smoking Cannabis: an Experimental Study (PISCES)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Carillon Skrzynski, PhD
- Phone Number: (734)788-2961
- Email: carillon.skrzynski@colorado.edu
Study Locations
-
-
Colorado
-
Boulder, Colorado, United States, 80309
- Recruiting
- University of Colorado at Boulder
-
Contact:
- Carillon Skrzynski, PhD
- Phone Number: (734)788-2961
- Email: carillon.skrzynski@colorado.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cold Water
|
Participants are assigned to cold water temperature and are video recorded.
|
|
Placebo Comparator: Warm Water
|
Participants are assigned to warm water temperature.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood Cortisol Levels
Time Frame: Pre-Use/Pre-Water Task, 20 minutes Post-Use, 40 minutes Post-Use
|
Cortisol levels are measured in blood.
|
Pre-Use/Pre-Water Task, 20 minutes Post-Use, 40 minutes Post-Use
|
|
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.
|
Immediate Post-Use
|
|
Blood Endocannabinoid Levels
Time Frame: Pre-Use/Pre-Water Task, 20 minutes Post-Use
|
Blood levels of AEA are measured.
|
Pre-Use/Pre-Water Task, 20 minutes Post-Use
|
|
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.
|
Pre-Use/Pre-Water Task, Pre-Use/Post-Water Task, 20 minutes Post-Use
|
|
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.
|
Pre-Use/Pre-Water Task
|
|
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.
|
Baseline
|
|
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.
|
Pre-Use/Pre-Water Task
|
|
Blood cannabinoid levels
Time Frame: Pre-Use/Pre-Water Task, 20 minutes Post-Use
|
THC and CBD blood levels are measured.
|
Pre-Use/Pre-Water Task, 20 minutes Post-Use
|
|
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.
|
Pre-Use/Pre-Water Task, Pre-Use/Post-Water Task, 20 minutes Post-Use, 40 minutes Post-Use
|
|
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.
|
Pre-Use/Pre-Water Task, Pre-Use/Post-Water Task, 20 minutes Post-Use, 40 minutes Post-Use
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23-03-0215
- 1K01DA058152-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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