Effect of Medical Marijuana on Neurocognition and Escalation of Use

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

269 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2022-11-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain Insomnia Depression Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Medical Marijuana Arm

This group can begin using medical marijuana immediately.

Group Type ACTIVE_COMPARATOR

Medical Marijuana

Intervention Type DRUG

Patients in this group can choose when, where, and how much medical marijuana to use.

Waitlist Control Arm

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Medical Marijuana

Patients in this group can choose when, where, and how much medical marijuana to use.

Intervention Type DRUG

Other Intervention Names

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Cannabis

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes