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 : September 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pain Insomnia Depression Anxiety||Drug: Medical Marijuana||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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|
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.
- 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).
- Changes in Symptoms of Depression and Anxiety [ Time Frame: Change from baseline to 3 months ]For those with depression and anxiety symptoms, the Hospital Anxiety and Depression Scale will be used to assess symptoms.
- 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.
- 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.
- 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.
- Cognitive Testing [ Time Frame: Change from baseline to 3 months ]Verbal learning/memory, attention, working memory, and complex decision-making will be assessed.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03224468
|Contact: Jodi M Gilman, PhD||617 643 email@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Jodi Gilman, PhD 617-643-7293 firstname.lastname@example.org|
|Principal Investigator: Jodi M Gilman, PhD|
|Principal Investigator:||Jodi M Gilman, PhD||Assistant Professor|