Perceptual Influences From Smoking Cannabis: an Experimental Study (PISCES)

June 12, 2025 updated by: Carillon Skrzynski, University of Colorado, Boulder

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

Study Type

Interventional

Enrollment (Estimated)

166

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2025

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

July 31, 2029

Study Registration Dates

First Submitted

September 6, 2024

First Submitted That Met QC Criteria

September 6, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

June 13, 2025

Last Update Submitted That Met QC Criteria

June 12, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

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)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe