Clinical trial NCT04116619: Investigating Stress-related Mechanisms in the Laboratory and Real World in Individuals With Cannabis Use Disorder
Official title: Investigating Stress-related Mechanisms in the Laboratory and Real World in Individuals With Cannabis Use Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cannabis Use Disorder
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2019-10-04
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with Cannabis Use Disorder and individuals who use cannabis \<1/week and do not meet criteria for Cannabis Use Disorder

Brief summary: This research project proposes a novel approach to elucidate the biological adaptations associated with Cannabis Use Disorder and to assess whether such adaptations are predictive of higher drug craving in response to both drug cues and stressors in both the laboratory and real-world, and higher relapse risk and drug use in the real world.

Detailed description: The intent of this study is to recruit 25 treatment-seeking individuals with Cannabis Use Disorder (CUD) and 25 light users (\<1 joint/week) to complete three guided imagery conditions (stress, cannabis, neutral) in inpatient research units. During the guided imagery, repeated measurements of subjective (i.e., craving, negative affect), neuroendocrine (i.e., cortisol), and physiological variables (i.e., heart rate variability \[HRV\]) will be collected. Thereafter, individuals with CUD will begin one-month of drug counseling treatment coupled with surveys delivered via smartphones daily in the morning, evening, and at four random times during the day.

Eligibility criteria: Inclusion Criteria:

* Cannabis using men and women who:
* 1. Are fluent in English;
* 2. Are using cannabis at levels to match either of the two groups:

  a) Light Users: i. Cannabis using levels of \< 1 joint/week ii. Has never met DSM-5 criteria for CUD or other substance use disorders. b) Individuals with Cannabis Use Disorder: i. Meets criteria for CUD based on the SCID (≤ 2 symptoms in past year); ii. Has a past-year cannabis use pattern of ≤3 times per week; iii.Do not meet criteria for any other substance use disorders other than mild Alcohol Use Disorder.
* 3. Provide a negative breathalyzer for alcohol and only positive for cannabis use at all appointments;
* 4. Can provide written informed consent.

Exclusion Criteria:

* 1. Meets current or past DSM-5 criteria for Axis I for major psychiatric disorders, other than depression or anxiety disorder;
* 2. Meets criteria for a current Substance Use Disorder other than Cannabis or mild Alcohol Use Disorder;
* 3. Has any significant current medical conditions requiring medication, including neurological, renal, thyroid, cardiovascular, liver, endocrine, or immune conditions;
* 4. Reports current use of medications/drugs that interfere with HPA axis response,
* 5. Are women who are pregnant or lactating, are peri-/post-menopausal, or those with hysterectomies;
* 6. Report current use of psychotropic drugs other than antidepressants.

Primary outcomes:
measure: Rating of craving in the laboratory
timeFrame: 3 days
measure: Rating of subjective stress in the laboratory
timeFrame: 3 days
measure: Rating of subjective craving in the real world
timeFrame: 28 days
measure: Rating of subjective stress in the real world
timeFrame: 28 days
measure: Physiological response to stress and cannabis cues in the laboratory
timeFrame: 3 days
measure: Heart rate response to stress and cannabis cues in the real world
timeFrame: 2 weeks
Secondary outcomes:
measure: Blood pressure- diastolic
timeFrame: 2 weeks
measure: Blood pressure- systolic
timeFrame: 2 weeks
measure: Change in Cannabis use- Labs
timeFrame: 4 weeks
measure: Change in Cannabis use- Self Report
timeFrame: 4 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Stress Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Stephanie Wemm, PhD
role: PRINCIPAL_INVESTIGATOR
References: