Effect of Medical Marijuana on Neurocognition and Escalation of Use (MMNE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03224468|
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : March 13, 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 Hamilton 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.
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
|Contact: Jodi M Gilman, PhD||617 643 firstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Jodi Gilman, PhD 617-643-7293 email@example.com|
|Principal Investigator: Jodi M Gilman, PhD|
|Principal Investigator:||Jodi M Gilman, PhD||Assistant Professor|