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Trial record 1 of 3 for:    Cannabis, Yale | Stress
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Investigating Stress-related Mechanisms in the Laboratory and Real World in Individuals With Cannabis Use Disorder

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ClinicalTrials.gov Identifier: NCT04116619
Recruitment Status : Not yet recruiting
First Posted : October 4, 2019
Last Update Posted : April 20, 2020
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Stephanie Wemm, Yale University

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.

Condition or disease Intervention/treatment
Cannabis Use Disorder Other: Guided Imagery Laboratory Session

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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigating Stress-related Mechanisms in the Laboratory and Real World in Individuals With Cannabis Use Disorder
Estimated Study Start Date : June 15, 2020
Estimated Primary Completion Date : October 15, 2024
Estimated Study Completion Date : April 15, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Group/Cohort Intervention/treatment
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
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.

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
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.




Primary Outcome Measures :
  1. Rating of craving in the laboratory [ Time Frame: 3 days ]
    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.

  2. Rating of subjective stress in the laboratory [ Time Frame: 3 days ]
    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. Rating of subjective craving in the real world [ Time Frame: 28 days ]
    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."

  4. Rating of subjective stress in the real world [ Time Frame: 28 days ]
    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."

  5. Physiological response to stress and cannabis cues in the laboratory [ Time Frame: 3 days ]
    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.

  6. Heart rate response to stress and cannabis cues in the real world [ Time Frame: 2 weeks ]
    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.


Secondary Outcome Measures :
  1. Blood pressure- diastolic [ Time Frame: 2 weeks ]
    A General Electric Dynamap will be used to place a blood pressure cuff on the subject's preferred arm to monitor blood pressure (BP) during the laboratory sessions in week 2 in order to assess change in BP responses to stress, drug cue and neutral provocation.

  2. Blood pressure- systolic [ Time Frame: 2 weeks ]
    A General Electric Dynamap will be used to place a blood pressure cuff on the subject's preferred arm to monitor blood pressure (BP) during the laboratory sessions in week 2 in order to assess change in BP responses to stress, drug cue and neutral provocation.

  3. Change in Cannabis use- Labs [ Time Frame: 4 weeks ]
    Cannabis use will be determined using a urine toxicology screen. Change in percent THCCOOH levels assessed via urine during the 4 week trial assessed by a weekly urine toxicology screen.

  4. Change in Cannabis use- Self Report [ Time Frame: 4 weeks ]
    Change over time in daily reporting of cannabis use per day will be assessed by self-report on the Timeline Followback.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04116619


Contacts
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Contact: Stephanie Wemm, PhD (203) 737-3436 stephanie.wemm@yale.edu

Sponsors and Collaborators
Yale University
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Stephanie Wemm, PhD Yale University
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Responsible Party: Stephanie Wemm, Associate Research Scientist, Yale University
ClinicalTrials.gov Identifier: NCT04116619    
Other Study ID Numbers: 2000026364
KL2TR001862 ( U.S. NIH Grant/Contract )
First Posted: October 4, 2019    Key Record Dates
Last Update Posted: April 20, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders