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Trial record 43 of 94 for:    Recruiting, Not yet recruiting, Active, not recruiting Studies | marijuana | United States

Effect of Medical Marijuana on Neurocognition and Escalation of Use (MMNE)

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ClinicalTrials.gov Identifier: NCT03224468
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Jodi Gilman, Massachusetts General Hospital

Brief Summary:
This study will use a randomized controlled design to test whether patients who use medical marijuana, compared to a waitlist control group, experience a change in health outcomes (relief of symptoms, or adverse health outcomes such as new-onset symptoms of cannabis use disorders, neurocognitive impairments) or brain-based changes.

Condition or disease Intervention/treatment Phase
Pain Insomnia Depression Anxiety Drug: Medical Marijuana Not Applicable

Detailed Description:
This trial is a randomized, longitudinal study of medical marijuana (MM) that will: (1) characterize the impact of MM on indices of addiction, such as CUD, escalation of use, tolerance, and withdrawal among those who stop using, (2) assess, via dosing diaries, the effect of MM use patterns on use of other medications, and perception of underlying disease symptomatology, (3) characterize the impact of MM on neurocognitive performance, including executive function, memory, attention, and decision-making and (4) examine evidence for impact of MM on brain structure and function. This study will enroll 200 adults with no prior history of CUD or heavy marijuana use, who express interest in using MM to treat pain, insomnia, anxiety, and/or depression. Participants will be randomly assigned to either an active MM arm (n = 100), or to a waitlist control arm (WLC) (n = 100). Participants will be assessed at baseline, regularly for 3 months, and at a 6-month and 12-month follow-up for MM use behaviors, development of CUD, perception of disease symptomatology, and neurocognitive performance. Urine collected at each visit will be assessed with quantitative assays. MRI scans will be collected to longitudinally investigate possible brain changes associated with MM use.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Medical Marijuana on Neurocognition and Escalation of Use
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
Active Comparator: Medical Marijuana Arm
This group can begin using medical marijuana immediately.
Drug: Medical Marijuana
Patients in this group can choose when, where, and how much medical marijuana to use.
Other Name: Cannabis

No Intervention: Waitlist Control Arm
This group agrees to wait 3 months before using medical marijuana.



Primary Outcome Measures :
  1. Cannabis Use Disorders [ Time Frame: Change from baseline to 3 months ]
    The DSM-5 Cannabis Use Disorder Checklist will evaluate symptoms of CUD (number of symptoms).

  2. Changes in Symptoms of Depression and Anxiety [ Time Frame: Change from baseline to 3 months ]
    For those with depression and anxiety symptoms, the Hamilton Anxiety and Depression Scale will be used to assess symptoms.

  3. Changes in Pain [ Time Frame: Change from baseline to 3 months ]
    For those with pain, a Numeric Rating Scale will be used to assess levels of pain.

  4. Changes in Sleep [ Time Frame: Change from baseline to 3 months ]
    For those with insomnia, the Athens Insomnia Scale will be used to assess symptoms.


Secondary Outcome Measures :
  1. General Medical/Psychiatric Health [ Time Frame: Change from baseline to 3 months ]
    The Short Form-12 Health Survey (SF-12) will be used to assess self report of emotional and physical functioning.

  2. Cognitive Testing [ Time Frame: Change from baseline to 3 months ]
    Verbal learning/memory, attention, working memory, and complex decision-making will be assessed.

  3. Brain-based Measures [ Time Frame: Change from baseline to 1 year ]
    Changes in resting state functional connectivity and task-associated activation in brain regions involved in reward, inhibitory control, and working memory will be assessed.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participant eligibility is based on self-representation of gender identity.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Men and women aged 18-65 years, inclusive;
  2. Competent and willing to provide written informed consent;
  3. Desire to use medical marijuana for self-reported pain, sleep, or affective (mood and/or anxiety including PTSD) symptoms.
  4. Not in possession of a medical marijuana card, but expressing intent to get one.
  5. Able to communicate in English language.

Exclusion Criteria:

  1. Current daily marijuana use (prior to enrollment)
  2. Current substance use disorders (e.g. cocaine, opiate, stimulant). Light to moderate alcohol use is permitted (defined as 16 or less on the AUDIT), and nicotine dependence is permitted because of the high co-use of nicotine and marijuana. Participants cannot meet current SCID criteria for a use disorder on any illicit substance other than nicotine.
  3. Pregnant (verified by a urine test).
  4. In the opinion of the investigator, not able to safely participate in this study because of any medical or psychological issues (e.g. psychosis) that might compromise their safety.

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): NCT03224468


Contacts
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Contact: Jodi M Gilman, PhD 617 643 7611 jgilman1@partners.org

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Jodi Gilman, PhD    617-643-7293    jgilman1@partners.org   
Principal Investigator: Jodi M Gilman, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Jodi M Gilman, PhD Assistant Professor

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Responsible Party: Jodi Gilman, Assistant Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03224468     History of Changes
Other Study ID Numbers: 2015P001600
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jodi Gilman, Massachusetts General Hospital:
medical marijuana
cannabis
pain
insomnia
depression
anxiety
addiction
dependence
neurocognition
MRI

Additional relevant MeSH terms:
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Marijuana Abuse
Depression
Sleep Initiation and Maintenance Disorders
Behavioral Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders