Clinical trial NCT05833230: Investigating Real-world Stress-related Mechanisms in Heavy Cannabis Users
Official title: Investigating Real-world Stress-related Mechanisms in Heavy Cannabis Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cannabis Use
Cannabis
Cannabis Abuse
Keywords: Cannabis
Marijuana
Smartphone
Cortisol
Heart rate variability
Ecological Momentary Assessment
Saliva
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Robert E. Leet and Clara Guthrie Patterson Trust Mentored Research Award
First posted: 2023-04-27
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Detailed description: As more states in the US have legalized recreational cannabis use, the number of individuals who use cannabis has also increased. Individuals are also using cannabis more frequently and in larger amounts as it has become more available and less challenging to purchase. These statistics are alarming because heavy use of cannabis has been linked to several societal and public health concerns, such as poorer mental health outcomes, higher rates of unemployment, and poorer life satisfaction. Many of these associations are associated with increased burden and stress; however, cannabis may alter how individuals cope biologically, such as the stress hormone cortisol, and psychologically with these stressors. For example, heavy use of alcohol and other drugs, such as cocaine or nicotine, change overall cortisol levels and how cortisol is released in response to stress. In laboratory studies, healthy individuals show a peak in cortisol following a stressor, whereas individuals who use alcohol and substances heavily have a less robust response. However, it is not known if this phenomenon occurs in individuals who use cannabis heavily in real-world stressful situations. Heavier use of alcohol or drugs is associated with wanting or craving drugs or alcohol more when in stressful situations. In this proposal, the team will use smartphone-delivered surveys combined with regular saliva sampling to examine the associations between psychological and biological stress responses and cannabis use. Individuals who use cannabis at least once weekly will be recruited to complete two weeks of smartphone surveys. The participants will also provide regular saliva samples and wear a heart rate monitor on three consecutive days within those two weeks. These saliva samples will be analyzed for the hormone cortisol and salivary alpha amylase. The team will examine if self-reported cannabis use predicts how an individual responds, both biological and psychological, to a stressor when they encounter it their daily life. The team will also investigate if individuals who use more cannabis are more likely to want to use cannabis when they encounter daily life stress. Results from this study can help us develop treatments that help individuals who use cannabis heavily better cope with stress.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Primary outcomes:
measure: Averaged cortisol response to stress and cannabis cues in the real world
timeFrame: 3 days in Week 1
measure: Ratings of subjective craving in the real world
timeFrame: 48 days
measure: Ratings of subjective subjective stress in the real world
timeFrame: 48 days
Secondary outcomes:
measure: Self-reported cannabis use
timeFrame: 48 days
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Stress Center
state: Connecticut
Study officials:
affiliation: Associate Research Scientist, Psychiatry
name: Stephanie Wemm, PhD
role: PRINCIPAL_INVESTIGATOR
References: