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

NCT04116619 | Completed DMC

• 2 other identifiers: 2000026364KL2TR001862
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Cannabis Use Disorder

Outcome Measures

Primary Outcomes (6)

• Rating of craving in the laboratory

  Participants will rate their level of stress and marijuana craving at five time points during the laboratory session, once at pre-baseline, baseline, immediately post-imagery procedures, and at three times point 15, 30, and 45 minutes post-imagery. Craving and stress will be assessed using a 100-point visual analog scale (VAS) in which 0="Not at all" and 100="Extremely High." Individuals with CUD will be compared to light marijuana users in their differences in slope in response to the imagery.

  3 days

• Rating of subjective stress in the laboratory

  Participants will rate their level of stress and marijuana craving at five time points during the laboratory session, once at pre-baseline, baseline, immediately post-imagery procedures, and at three times point 15, 30, and 45 minutes post-imagery. Craving and stress will be assessed using a 100-point visual analog scale (VAS) in which 0="Not at all" and 100="Extremely High." Individuals with CUD will be compared to light marijuana users in their differences in slope in response to the imagery.

  3 days

• Rating of subjective craving in the real world

  Participants will report using ecological momentary assessment (EMA) their current levels of stress and craving, if they have used marijuana, and if they experienced a stressor. 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 during marijuana use. Individuals with CUD will be compared to light marijuana users in their differences in real-world ratings of stress and craving. Craving and stress will be assessed using a 100-point visual analog scale (VAS) in which 0="Not at all" and 100="Extremely High."

  28 days

• Rating of subjective stress in the real world

  Participants will report using ecological momentary assessment (EMA) their current levels of stress and craving, if they have used marijuana, and if they experienced a stressor. 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 during marijuana use. Individuals with CUD will be compared to light marijuana users in their differences in real-world ratings of stress and craving. Craving and stress will be assessed using a 100-point visual analog scale (VAS) in which 0="Not at all" and 100="Extremely High."

  28 days

• Physiological response to stress and cannabis cues in the laboratory

  Plasma will be collected at each laboratory session to assess cortisol response to stress, drug cue, and neutral imagery exposure. Heart Rate Variability (HRV) measured via the Firstbeat Bodyguard 2 will be used to assess cardiovascular response to stress, drug, and neutral cue imagery exposure.

  3 days

• Heart rate response to stress and cannabis cues in the real world

  Heart Rate Variability (HRV) will be collected throughout the day on two separate three-day occasions during Weeks 1 and Week 2 via the Firstbeat Bodyguard.

  2 weeks

Secondary Outcomes (4)

• Blood pressure- diastolic

  2 weeks

• Blood pressure- systolic

  2 weeks

• Change in Cannabis use- Labs

  4 weeks

• Change in Cannabis use- Self Report

  4 weeks

Study Arms (2)

Individuals with Cannabis Use Disorder

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.

Other: Guided Imagery Laboratory Session

Light Cannabis Users

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.

Other: Guided Imagery Laboratory Session

Interventions

Guided Imagery Laboratory Session OTHER

On days 1, 2 and 3 of the study, subjects will come to the research testing rooms and be provided with lunch before beginning the laboratory session. After a 40-minute adaptation period, two blood samples will be drawn before imagery (BASELINE). After the second blood draw, a 5-minute baseline period will follow to assess continuous pulse rate, BP, and HRV assessments. The subject and research staff conducting the sessions will be blinded to the order and content of the imagery condition. In each recording, the subjects will listen to the scripts over headphones and will vividly imagine the described situation, 'as if' it were happening right now," for 5 minutes. The research nurse will take a blood draw immediately after the imagery (IMAGERY). After that, three recovery blood draws will be performed at 15-minute intervals (RECOVERY). We will analyze the total of six blood samples for levels of cortisol.

Individuals with Cannabis Use Disorder; Light Cannabis Users

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• Cannabis using men and women who:
• \. Are fluent in English;
• \. 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.
• \. Provide a negative breathalyzer for alcohol and only positive for cannabis use at all appointments;
• \. Can provide written informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• Yale University: lead
• National Institutes of Health (NIH): collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Yale Stress Center

New Haven, Connecticut, 06519, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva samples

Study Officials

• Stephanie Wemm, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Research Scientist

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 4, 2019
• Study Start: February 1, 2021
• Primary Completion: September 30, 2021
• Study Completion: February 1, 2022
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)