Investigating Real-world Stress-related Mechanisms in Heavy Cannabis Users

NCT05833230 | Completed

• 1 other identifier: 2000034321
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This research project proposes a novel approach to elucidate the biological adaptations associated with heavy cannabis use and to assess whether such adaptations are predictive of higher cannabis craving in response to both cannabis cues and stressors.

Conditions

Cannabis Use; Cannabis; Cannabis Abuse

Keywords

Cannabis; Marijuana; Smartphone; Cortisol; Heart rate variability; Ecological Momentary Assessment; Saliva

Outcome Measures

Primary Outcomes (3)

• Averaged cortisol response to stress and cannabis cues in the real world

  Saliva samples for cortisol levels will be collected throughout the day on a randomly selected three-day period during week 1 of the study. The data will be averaged on all three days and not treated as separate time points.

  3 days in Week 1

• Ratings of subjective craving in the real world

  Participants will report using ecological momentary assessment (EMA) their current levels of craving. These reports will be generated in three different ways: at 8 am and 8 pm at night, at four random times during waking hours, and while drinking alcohol. Craving will be assessed using a 100-point visual analog scale (VAS) in which 0="Not at all" and 100="Extremely High."

  48 days

• Ratings of subjective subjective stress in the real world

  Participants will report using ecological momentary assessment (EMA) their current levels of stress. These reports will be generated in three different ways: at 8 am and 8 pm at night, at four random times during waking hours, and while drinking alcohol. Stress will be assessed using a 100-point visual analog scale (VAS) in which 0="Not at all" and 100="Extremely High."

  48 days

Secondary Outcomes (1)

• Self-reported cannabis use

  48 days

Study Arms (1)

Individuals who use cannabis

EXPERIMENTAL

Participants who are non-treatment seeking cannabis users (30 men, 30 women) ranging from once weekly use to multiple times daily. All participants will be recruited from the greater New Haven community and will complete four weeks of smartphone monitoring. During this monitoring period, they will also complete two three-consecutive days of intensive monitoring including more frequent smartphone surveys, saliva samples, heart rate monitoring, and an alcohol use monitor.

Other: Intensive Day Monitoring

Interventions

Intensive Day Monitoring OTHER

During intake, a research assistant will demonstrate how to place the Heart Rate Variability monitor and provide instructions on completing the saliva samples at home. Participants will wear the Heart Rate Variability monitor for three consecutive, randomly selected days twice (72 hours each). Participants will be provided with six saliva sample collection tubes per day with explicit directions on when the saliva sampling should occur (hours since waking: +0, +1, +2, +4, +6, +10 hours, and before going to sleep). Participants will also complete a subjective report using similar questions included in the survey prompts at the same scheduled time as the saliva sample. All participants will complete a total of 6 such days during the study.

Individuals who use cannabis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cannabis-using men and women who:
• have a past-year pattern of 1 or more cannabis use episodes per week
• do not meet criteria for any other substance use disorders other than mild Cannabis and Alcohol Use Disorder
• are at least 18 years old
• are fluent in English
• can provide negative alcohol breathalyzer and only positive for cannabis at all visits.
• can provide written informed consent.

You may not qualify if:

• Individuals will be excluded if they:
• meeting current or past for major psychiatric disorders, other than depression or anxiety disorder;
• meeting criteria for a current Substance Use Disorder other than mild Cannabis Use Disorder and Alcohol Use Disorder;
• any significant current medical conditions requiring medication, including neurological, renal, thyroid, cardiovascular, liver, endocrine, or immune conditions
• current use of medications that interfere with hypothalamic-pituitary-adrenal axis response
• women who are pregnant, lactating, peri-/post-menopausal, or with hysterectomies
• current use of psychotropic drugs other than antidepressants.

Sponsors & Collaborators

• Yale University: lead
• Robert E. Leet and Clara Guthrie Patterson Trust Mentored Research Award: collaborator

Study Sites (1)

Yale Stress Center

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Marijuana Abuse

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Stephanie Wemm, PhD

  Associate Research Scientist, Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: April 27, 2023
• Study Start: June 1, 2023
• Primary Completion: February 26, 2025
• Study Completion: February 26, 2025
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)