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Clinical Trials/NCT06588582
NCT06588582RecruitingNot Applicable

Exploring the Antecedents and Consequences of Cannabis Use in the Context of Coping: An Experimental Study

University of Colorado, Boulder1 site in 1 country166 target enrollmentStarted: February 17, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
166
Locations
1
Primary Endpoint
Blood Cortisol Levels

Study Overview

Brief 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.

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
21 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Warm Water

Placebo Comparator

Intervention: Water Temperature Variation - WW (Other)

Cold Water

Experimental

Intervention: Water Temperature Variation - CW (Other)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Carillon Skrzynski

Research Assistant Professor

University of Colorado, Boulder

Study Sites (1)

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