Investigating Stress-related Mechanisms in the Laboratory and Real World in Individuals With Cannabis Use Disorder

Yale University

Status: Completed

Conditions: Cannabis Use Disorder

Treatments: Other: Guided Imagery Laboratory Session

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04116619

2000026364

KL2TR001862 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

39 participants in 2 patient groups

Individuals with Cannabis Use Disorder

Description:

Participants who meet criteria for Cannabis Use Disorder will complete three guided imagery conditions (stress, cannabis, neutral) in an inpatient research unit. 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.

Treatment:

Other: Guided Imagery Laboratory Session

Light Cannabis Users

Description:

Participants who are light cannabis users (\<1 joint/week) will complete three guided imagery conditions (stress, cannabis, neutral) in an inpatient research unit. 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.

Treatment:

Other: Guided Imagery Laboratory Session