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

Primary Purpose

Pain, Insomnia, Depression

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medical Marijuana
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring medical marijuana, cannabis, pain, insomnia, depression, anxiety, addiction, dependence, neurocognition, MRI

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Medical Marijuana Arm

Waitlist Control Arm

Arm Description

This group can begin using medical marijuana immediately.

This group agrees to wait 3 months before using medical marijuana.

Outcomes

Primary Outcome Measures

Cannabis Use Disorders
The DSM-5 Cannabis Use Disorder Checklist will evaluate symptoms of CUD (number of symptoms).
Changes in Symptoms of Depression and Anxiety
For those with depression and anxiety symptoms, the Hospital Anxiety and Depression Scale will be used to assess symptoms.
Changes in Pain
For those with pain, a Numeric Rating Scale (BPI) will be used to assess levels of pain.
Changes in Sleep
For those with insomnia, the Athens Insomnia Scale will be used to assess symptoms.

Secondary Outcome Measures

General Medical/Psychiatric Health
The Short Form-12 Health Survey (SF-12) will be used to assess self report of emotional and physical functioning.
Cognitive Testing
Verbal learning/memory, attention, working memory, and complex decision-making will be assessed.
Brain-based Measures
Changes in resting state functional connectivity and task-associated activation in brain regions involved in reward, inhibitory control, and working memory will be assessed.

Full Information

First Posted
July 17, 2017
Last Updated
July 28, 2021
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03224468
Brief Title
Effect of Medical Marijuana on Neurocognition and Escalation of Use
Acronym
MMNE
Official Title
Effect of Medical Marijuana on Neurocognition and Escalation of Use
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
March 31, 2022 (Anticipated)
Study Completion Date
March 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Insomnia, Depression, Anxiety
Keywords
medical marijuana, cannabis, pain, insomnia, depression, anxiety, addiction, dependence, neurocognition, MRI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
188 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medical Marijuana Arm
Arm Type
Active Comparator
Arm Description
This group can begin using medical marijuana immediately.
Arm Title
Waitlist Control Arm
Arm Type
No Intervention
Arm Description
This group agrees to wait 3 months before using medical marijuana.
Intervention Type
Drug
Intervention Name(s)
Medical Marijuana
Other Intervention Name(s)
Cannabis
Intervention Description
Patients in this group can choose when, where, and how much medical marijuana to use.
Primary Outcome Measure Information:
Title
Cannabis Use Disorders
Description
The DSM-5 Cannabis Use Disorder Checklist will evaluate symptoms of CUD (number of symptoms).
Time Frame
Change from baseline to 3 months
Title
Changes in Symptoms of Depression and Anxiety
Description
For those with depression and anxiety symptoms, the Hospital Anxiety and Depression Scale will be used to assess symptoms.
Time Frame
Change from baseline to 3 months
Title
Changes in Pain
Description
For those with pain, a Numeric Rating Scale (BPI) will be used to assess levels of pain.
Time Frame
Change from baseline to 3 months
Title
Changes in Sleep
Description
For those with insomnia, the Athens Insomnia Scale will be used to assess symptoms.
Time Frame
Change from baseline to 3 months
Secondary Outcome Measure Information:
Title
General Medical/Psychiatric Health
Description
The Short Form-12 Health Survey (SF-12) will be used to assess self report of emotional and physical functioning.
Time Frame
Change from baseline to 3 months
Title
Cognitive Testing
Description
Verbal learning/memory, attention, working memory, and complex decision-making will be assessed.
Time Frame
Change from baseline to 3 months
Title
Brain-based Measures
Description
Changes in resting state functional connectivity and task-associated activation in brain regions involved in reward, inhibitory control, and working memory will be assessed.
Time Frame
Change from baseline to 1 year

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Participant eligibility is based on self-representation of gender identity.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Men and women aged 18-65 years, inclusive; Competent and willing to provide written informed consent; Desire to use medical marijuana for self-reported pain, sleep, or affective (mood and/or anxiety including PTSD) symptoms. Not in possession of a medical marijuana card, but expressing intent to get one. Able to communicate in English language. Exclusion Criteria: Current daily marijuana use (prior to enrollment) 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. Pregnant (verified by a urine test). 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jodi M Gilman, PhD
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35302633
Citation
Gilman JM, Schuster RM, Potter KW, Schmitt W, Wheeler G, Pachas GN, Hickey S, Cooke ME, Dechert A, Plummer R, Tervo-Clemmens B, Schoenfeld DA, Evins AE. Effect of Medical Marijuana Card Ownership on Pain, Insomnia, and Affective Disorder Symptoms in Adults: A Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e222106. doi: 10.1001/jamanetworkopen.2022.2106.
Results Reference
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Effect of Medical Marijuana on Neurocognition and Escalation of Use

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