MMNE: Effect of Medical Marijuana on Neurocognition and Escalation of Use

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03224468

Collaborator

(none)

188

Enrollment

Location

Arms

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Insomnia Depression Anxiety	Drug: Medical Marijuana	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

188 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 :

Jul 1, 2017

Anticipated Primary Completion Date :

Mar 31, 2022

Anticipated Study Completion Date :

Mar 31, 2022

Arms and Interventions

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

Cannabis

No Intervention: Waitlist Control Arm

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

Outcome Measures

Primary Outcome Measures

Cannabis Use Disorders [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 [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 [Change from baseline to 3 months]
For those with pain, a Numeric Rating Scale (BPI) will be used to assess levels of pain.
Changes in Sleep [Change from baseline to 3 months]
For those with insomnia, the Athens Insomnia Scale will be used to assess symptoms.

Secondary Outcome Measures

General Medical/Psychiatric Health [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 [Change from baseline to 3 months]
Verbal learning/memory, attention, working memory, and complex decision-making will be assessed.
Brain-based Measures [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.