PainMMNENCT03224468

Effect of Medical Marijuana on Neurocognition and Escalation of Use

A study testing Medical Marijuana in people with Pain and Insomnia, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Pain, Insomnia, Depression
What is being tested?: Medical Marijuana
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 269 participants
Where: 1 siteUnited States
Study dates: 1 Jul 2017to 1 Nov 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

Read the 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.

Conditions: Pain, Insomnia, Depression, Anxiety
Being tested: Medical Marijuana
Keywords: medical marijuana, cannabis, pain, insomnia, depression, anxiety, addiction, dependence, neurocognition, MRI
Medical subject headings: Pain, Sleep Initiation and Maintenance Disorders, Depression, Anxiety Disorders, Marijuana Abuse, Behavior, Addictive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Medical MarijuanaDrug
Also called Cannabis
Patients in this group can choose when, where, and how much medical marijuana to use.

Study groups in NCT03224468
Study group	Role	What they receive
Medical Marijuana Arm	Active comparator	This group can begin using medical marijuana immediately. Receives: Drug: Medical Marijuana
Waitlist Control Arm	No intervention	This group agrees to wait 3 months before using medical marijuana.

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Difference in Number of Cannabis Use Disorder Symptoms Averaged Over 2, 4, and 12 Weeks
The DSM-5 Cannabis Use Disorder (CUD) Checklist will evaluate symptoms of CUD (number of symptoms). The scale ranges from 0-11, with a higher score indicating a greater number of cannabis use disorder symptoms. A trained member of study staff assessed number of CUD symptoms through a structured interview. Each item was scored as "1" if the participant endorsed the symptom, and scored as "0" if they did not endorse the symptom. Reported results are an average taken over weeks 2, 4, and 12 to be consistent with the regression model estimates.
Measured: 2 weeks, 4 weeks, and 12 weeks
Mean Difference in Depression Subscale Scores From the HADS Averaged Over 2, 4, and 12 Weeks
For those with depression symptoms, the depression subscale of the Hospital Anxiety and Depression Scale (HADS) will be used to assess symptoms. The subscale ranges from 0-21, with a higher score indicating worse depression outcomes. Reported results are an average taken over weeks 2, 4, and 12 to be consistent with the regression model estimates.
Measured: 2 weeks, 4 weeks, and 12 weeks
Mean Difference in Anxiety Subscale Scores From the HADS Averaged Over 2, 4, and 12 Weeks
For those with anxiety symptoms, the anxiety subscale from the Hospital Anxiety and Depression Scale (HADS) will be used to assess symptoms. This subscale ranges from 0-21, with higher scores indicating worse anxiety outcomes. Reported results are an average taken over weeks 2, 4, and 12 to be consistent with the regression model estimates.
Measured: 2 Weeks, 4 Weeks, and 12 Weeks
Mean Difference in Pain Severity Scores on the BPI Average Over 2, 4, and 12 Weeks
For those with pain, the Brief Pain Inventory (BPI) severity subscale was used to assess pain symptoms. This scale ranges from 0-10, with a higher score indicating greater pain severity. Reported results are an average taken over weeks 2, 4, and 12 to be consistent with the regression model estimates.
Measured: 2 weeks, 4 weeks, and 12 weeks
Mean Difference in Sleep Scores on the AIS Averaged Over 2, 4, and 12 Weeks
For those with insomnia, the Athens Insomnia Scale (AIS) will be used to assess insomnia symptoms. This scale ranges from 0-24, with higher scores indicating worse sleep outcomes. Reported results are an average taken over weeks 2, 4, and 12 to be consistent with the regression model estimates.
Measured: 2 weeks, 4 weeks, and 12 weeks

Secondary outcomes (9)

Mean Difference in Physical Health Scores on the SF-12 Averaged Over 2, 4, and 12 Weeks
The Short Form-12 Health Survey (SF-12) Physical Health Summary Scale was used to assess self-report of physical health. SF-12 scores are based on an Item Response Theory model, in which they are z-scores rescaled to have a mean of 50 (SD=10) in any typical population. There are no range limits to this measure. Higher scores indicate better physical health functioning. Reported results are an average taken over weeks 2, 4, and 12 to be consistent with the regression model estimates.
Measured: 2 weeks, 4 weeks, and 12 weeks
Mean Difference in Mental Health Scores on the SF-12 Averaged Over 2, 4, and 12 Weeks
The Short Form 12 Health Survey (SF-12) Mental Health Summary Scale was used to assess self-report of mental health. SF-12 scores are based on an Item Response Theory model, in which they are z-scores rescaled to have a mean of 50 (SD=10) in any typical population. This measure has no range limits. Higher scores indicate better mental health functioning. Reported results are an average taken over weeks 2, 4, and 12 to be consistent with the regression model estimates.
Measured: 2 weeks, 4 weeks, and 12 weeks
Mean Difference in Attention Switching Task: Congruency Cost Scores on the CANTAB Averaged Over 4 and 12 Weeks
Congruency cost was assessed wth the Attention Switching Task (AST), which assesses attention shifting and executive function via a simple task assessing the direction (pointing left or right) and position (on the left or right side) of an arrow, and is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The range of this measure is -1900 to 1900 ms. It is calculated as the difference in the median latency for incongruent trials (i.e., trials where the direction of the arrow differs from the side it appears) minus the median latency for congruent trials (i.e., trials where the direction of the arrow matches the side it appears). Positive values indicate faster responses to congruent trials. Reported results are an average taken over weeks 4 and 12 to be consistent with the regression model estimates.
Measured: 4 weeks and 12 weeks
Mean Difference in Attention Switching Task: Switching Cost Scores on the CANTAB Averaged Over 4 and 12 Weeks
Switching cost was assessed with the Attention Switching Task (AST), which assesses attention shifting and executive function via a simple task assessing the direction (pointing left or right) and position (on the left or right side) of an arrow, and is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The range for this measure is -1900 to 1900 ms. It is calculated as the difference in the median latency for blocks of switching trials (i.e., blocks of trials where the response rule switches between indicating the direction of the arrow or the position of the arrow) minus the median latency for blocks of non-switching trials (i.e., blocks of trials where the response rule is always either to indicate the direction of the arrow or the position of the arrow across all trials). Positive scores indicate faster responses to non-switching trials. Reported results are an average taken over weeks 4 and 12 to be consistent with the regression model estimates.
Measured: 4 weeks and 12 weeks
Mean Difference in Rapid Visual Information Processing (RVP) Task: Discriminability Scores on the CANTAB Averaged Over 4 and 12 Weeks
Discriminability was assessed with the Rapid Visual Information Processing (RVP) Task, which assesses sustained attention and is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). Discriminability scores are based on a transformation of response times and accuracy using the EZ-Diffusion model. There are no limits for this measure. Higher scores indicate that subjects can better discriminator between targets and distractors. Reported results are an average taken over weeks 4 and 12 to be consistent with the regression model estimates.
Measured: 4 weeks and 12 weeks
Mean Difference in Paired Associates Learning (PAL) Task: Total Errors Scores on the CANTAB Averaged Over 4 and 12 Weeks
Total errors were assessed with the Paired Associates Learning (PAL) task, which assesses visual memory and is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The range for this measure is 0 to 70 errors. Higher scores indicate that the subject committed more errors (worse performance). Reported results are an average taken over weeks 4 and 12 to be consistent with the regression model estimates.
Measured: 4 weeks and 12 weeks
Mean Difference in Spatial Working Memory (SWM) Task: Repetition Errors Scores on the CANTAB Averaged Over 4 and 12 Weeks
Repetition errors were assessed with the Spatial Working Memory (SWM) task, which assesses spatial working memory and executive function. It is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The range for this measure is 0 to 63 errors. Higher scores indicate that more repetition errors were committed (worse performance). Reported results are an average taken over weeks 4 and 12 to be consistent with the regression model estimates.
Measured: 4 weeks and 12 weeks
Mean Difference in Verbal Recognition Memory (VRM) Task: d' Scores on the CANTAB Averaged Over 4 and 12 Weeks
Discriminability was assessed with the Verbal Recognition Memory task (VRM), which assess verbal memory. It is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). Discriminability scores are based on a transformation of hit and false alarm rates using a signal detection theory (SDT) model.There are no limits for this measure. Higher scores indicate that a subject was able to better discriminate between previously studied and novel words. Reported results are an average taken over weeks 4 and 12 to be consistent with the regression model estimates.
Measured: 4 weeks and 12 weeks
Mean Difference in Verbal Recognition Memory (VRM) Task: Free Recall Memory Scores on the CANTAB Averaged Over 4 and 12 Weeks
Free Recall Memory was assessed with the Verbal Recognition Memory task (VRM), which assesses verbal memory. It is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The range for this measure is 0 to 18 words recalled. Higher scores indicate that subjects were able to correctly recall more previously studied words. Reported results are an average taken over weeks 4 and 12 to be consistent with the regression model estimates.
Measured: 4 weeks and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 20171 Nov 2022

First posted21 Jul 2017
Study start1 Jul 2017
Primary completion5 Feb 2021
Study completion1 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for PainStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 269 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03224468
Sponsor's protocol ID: 2015P001600
Acronym: MMNE
Status last verified: Feb 2023
First submitted: 17 Jul 2017
Last updated: 15 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Burdinski D, Kodibagkar A, Potter K, Schuster R, Evins AE, Ghosh S, Gilman J. Impact of year-long cannabis use for medical symptoms on brain activation during cognitive processes. medRxiv [Preprint]. 2024 May 1:2024.04.29.24306516. doi: 10.1101/2024.04.29.24306516.
PubMed 38746368
Livne O, Potter KW, Schuster RM, Gilman JM. Longitudinal Associations Between Cannabis Use and Cognitive Impairment in a Clinical Sample of Middle-Aged Adults Using Cannabis for Medical Symptoms. Cannabis Cannabinoid Res. 2024 Jun;9(3):e933-e938. doi: 10.1089/can.2022.0310. Epub 2023 Aug 25.
PubMed 37625034
Weiss JH, Tervo-Clemmens B, Potter KW, Evins AE, Gilman JM. The Cannabis Effects Expectancy Questionnaire-Medical (CEEQ-M): Preliminary psychometric properties and longitudinal validation within a clinical trial. Psychol Assess. 2023 Aug;35(8):659-673. doi: 10.1037/pas0001244. Epub 2023 Jun 8.
PubMed 37289502
Gilman JM, Potter K, Schuster RM, Hoeppner BB, Evins AE. Cannabis use for medical symptoms: Patterns over the first year of use. Addict Behav. 2023 Sep;144:107719. doi: 10.1016/j.addbeh.2023.107719. Epub 2023 Apr 13.
PubMed 37068366
Tervo-Clemmens B, Schmitt W, Wheeler G, Cooke ME, Schuster RM, Hickey S, Pachas GN, Evins AE, Gilman JM. Cannabis use and sleep quality in daily life: An electronic daily diary study of adults starting cannabis for health concerns. Drug Alcohol Depend. 2023 Feb 1;243:109760. doi: 10.1016/j.drugalcdep.2022.109760. Epub 2022 Dec 29.
PubMed 36638745
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.
PubMed 35302633

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Medical Marijuana on Neurocognition and Escalation of Use
ClinicalTrials.gov ID: NCT03224468
Acronym / sponsor ID: MMNE / 2015P001600
Conditions: Pain, Insomnia, Depression, Anxiety
Keywords: medical marijuana, cannabis, pain, insomnia, depression, anxiety, addiction, dependence
Study type: Interventional
Recruitment status: Completed
Enrolment: 269 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Study start: 1 Jul 2017 (actual)
Primary completion: 5 Feb 2021 (actual)
Study completion: 1 Nov 2022 (actual)
First posted: 21 Jul 2017 (actual)
Results: Posted 15 Nov 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Medical Marijuana Arm	Active comparator	Drug: Medical MarijuanaThis group can begin using medical marijuana immediately.
Waitlist Control Arm	No intervention	–This group agrees to wait 3 months before using medical marijuana.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Medical MarijuanaAlso: CannabisPatients in this group can choose when, where, and how much medical marijuana to use.	Drug	Medical Marijuana Arm

Primary outcome

Mean Difference in Number of Cannabis Use Disorder Symptoms Averaged Over 2, 4, and 12 Weeks
Time frame: 2 weeks, 4 weeks, and 12 weeks
The DSM-5 Cannabis Use Disorder (CUD) Checklist will evaluate symptoms of CUD (number of symptoms). The scale ranges from 0-11, with a higher score indicating a greater number of cannabis use disorder symptoms. A trained member of study staff assessed number of CUD symptoms through a structured interview. Each item was scored as "1" if the participant endorsed the symptom, and scored as "0" if they did not endorse the symptom. Reported results are an average taken over weeks 2, 4, and 12 to be consistent with the regression model estimates.
Mean Difference in Depression Subscale Scores From the HADS Averaged Over 2, 4, and 12 Weeks
Time frame: 2 weeks, 4 weeks, and 12 weeks
For those with depression symptoms, the depression subscale of the Hospital Anxiety and Depression Scale (HADS) will be used to assess symptoms. The subscale ranges from 0-21, with a higher score indicating worse depression outcomes. Reported results are an average taken over weeks 2, 4, and 12 to be consistent with the regression model estimates.
Mean Difference in Anxiety Subscale Scores From the HADS Averaged Over 2, 4, and 12 Weeks
Time frame: 2 Weeks, 4 Weeks, and 12 Weeks
For those with anxiety symptoms, the anxiety subscale from the Hospital Anxiety and Depression Scale (HADS) will be used to assess symptoms. This subscale ranges from 0-21, with higher scores indicating worse anxiety outcomes. Reported results are an average taken over weeks 2, 4, and 12 to be consistent with the regression model estimates.
Mean Difference in Pain Severity Scores on the BPI Average Over 2, 4, and 12 Weeks
Time frame: 2 weeks, 4 weeks, and 12 weeks
For those with pain, the Brief Pain Inventory (BPI) severity subscale was used to assess pain symptoms. This scale ranges from 0-10, with a higher score indicating greater pain severity. Reported results are an average taken over weeks 2, 4, and 12 to be consistent with the regression model estimates.
Mean Difference in Sleep Scores on the AIS Averaged Over 2, 4, and 12 Weeks
Time frame: 2 weeks, 4 weeks, and 12 weeks
For those with insomnia, the Athens Insomnia Scale (AIS) will be used to assess insomnia symptoms. This scale ranges from 0-24, with higher scores indicating worse sleep outcomes. Reported results are an average taken over weeks 2, 4, and 12 to be consistent with the regression model estimates.

9 secondary outcomes

Mean Difference in Physical Health Scores on the SF-12 Averaged Over 2, 4, and 12 Weeks
Time frame: 2 weeks, 4 weeks, and 12 weeks
Mean Difference in Mental Health Scores on the SF-12 Averaged Over 2, 4, and 12 Weeks
Time frame: 2 weeks, 4 weeks, and 12 weeks
Mean Difference in Attention Switching Task: Congruency Cost Scores on the CANTAB Averaged Over 4 and 12 Weeks
Time frame: 4 weeks and 12 weeks
Mean Difference in Attention Switching Task: Switching Cost Scores on the CANTAB Averaged Over 4 and 12 Weeks
Time frame: 4 weeks and 12 weeks
Mean Difference in Rapid Visual Information Processing (RVP) Task: Discriminability Scores on the CANTAB Averaged Over 4 and 12 Weeks
Time frame: 4 weeks and 12 weeks
Mean Difference in Paired Associates Learning (PAL) Task: Total Errors Scores on the CANTAB Averaged Over 4 and 12 Weeks
Time frame: 4 weeks and 12 weeks
Mean Difference in Spatial Working Memory (SWM) Task: Repetition Errors Scores on the CANTAB Averaged Over 4 and 12 Weeks
Time frame: 4 weeks and 12 weeks
Mean Difference in Verbal Recognition Memory (VRM) Task: d' Scores on the CANTAB Averaged Over 4 and 12 Weeks
Time frame: 4 weeks and 12 weeks
Mean Difference in Verbal Recognition Memory (VRM) Task: Free Recall Memory Scores on the CANTAB Averaged Over 4 and 12 Weeks
Time frame: 4 weeks and 12 weeks

Results and safety

Results posted to the registry on 15 Nov 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Medical Marijuana Arm	173	105
Waitlist Control Arm	96	81

Primary outcome: Mean Difference in Number of Cannabis Use Disorder Symptoms Averaged Over 2, 4, and 12 Weeks

Time frame: 2 weeks, 4 weeks, and 12 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Medical Marijuana Arm n = 105	Waitlist Control Arm n = 81
Value	0.39 (0.78)	0.12 (0.48)

Medical Marijuana Arm vs Waitlist Control Arm: Mean Difference (Net): 0.28 (95% CI 0.15 to 0.40), p <0.001, Regression, Linear

Primary outcome: Mean Difference in Depression Subscale Scores From the HADS Averaged Over 2, 4, and 12 Weeks

Time frame: 2 weeks, 4 weeks, and 12 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Medical Marijuana Arm n = 46	Waitlist Control Arm n = 37
Value	5.4 (4.3)	5.0 (3.9)

Medical Marijuana Arm vs Waitlist Control Arm: Mean Difference (Net): -0.5 (95% CI -1.4 to 0.4), p = 0.50, Regression, Linear

Population analysed: The analysis is restricted to the subset of 83 participants out of 186 total who intended to use medical marijuana to address concerns for anxiety and depression.

Primary outcome: Mean Difference in Anxiety Subscale Scores From the HADS Averaged Over 2, 4, and 12 Weeks

Time frame: 2 Weeks, 4 Weeks, and 12 Weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Medical Marijuana Arm n = 46	Waitlist Control Arm n = 37
Value	8.4 (4.4)	8.4 (3.8)

Medical Marijuana Arm vs Waitlist Control Arm: Mean Difference (Net): -0.02 (95% CI -0.30 to 0.24), p = 0.90, Regression, Linear

Population analysed: The analysis is restricted to the subset of 83 participants out of 186 total who intended to use medical marijuana to address concerns for anxiety and depression.

Primary outcome: Mean Difference in Pain Severity Scores on the BPI Average Over 2, 4, and 12 Weeks

Time frame: 2 weeks, 4 weeks, and 12 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Medical Marijuana Arm n = 37	Waitlist Control Arm n = 24
Value	2.7 (2.3)	3.3 (2.5)

Medical Marijuana Arm vs Waitlist Control Arm: Mean Difference (Net): 0.02 (95% CI -0.38 to 0.39), p = 0.93, Regression, Linear

Population analysed: The analysis is restricted to the subset of 61 participants out of 186 total who intended to use medical marijuana to address concerns for pain.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected for 3 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Medical Marijuana Arm	1 of 105 (1%)	90 of 105 (85.7%)	0 of 105
Waitlist Control Arm	0 of 81 (0%)	60 of 81 (74.1%)	0 of 81

Limitations and caveats (from the sponsor): Participants used variety of commercial medical cannabis products of their choice, at self-titrated doses; We do not attempt to comment on pharmacologic effects, risks, or benefits, of specific cannabinoids at specific doses; Inclusion based on self-reported symptoms, which may limit generalizability to those with formal diagnoses; Homogenous sample in terms of race, ethnicity; high dropout in the MMC group between randomization and baseline, reflecting cost and burden of obtaining a MMC.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38746368Burdinski D, Kodibagkar A, Potter K, Schuster R, Evins AE, Ghosh S, Gilman J. Impact of year-long cannabis use for medical symptoms on brain activation during cognitive processes. medRxiv [Preprint]. 2024 May 1:2024.04.29.24306516. doi: 10.1101/2024.04.29.24306516.
Derived from this study: PubMed 37625034Livne O, Potter KW, Schuster RM, Gilman JM. Longitudinal Associations Between Cannabis Use and Cognitive Impairment in a Clinical Sample of Middle-Aged Adults Using Cannabis for Medical Symptoms. Cannabis Cannabinoid Res. 2024 Jun;9(3):e933-e938. doi: 10.1089/can.2022.0310. Epub 2023 Aug 25.
Derived from this study: PubMed 37289502Weiss JH, Tervo-Clemmens B, Potter KW, Evins AE, Gilman JM. The Cannabis Effects Expectancy Questionnaire-Medical (CEEQ-M): Preliminary psychometric properties and longitudinal validation within a clinical trial. Psychol Assess. 2023 Aug;35(8):659-673. doi: 10.1037/pas0001244. Epub 2023 Jun 8.
Derived from this study: PubMed 37068366Gilman JM, Potter K, Schuster RM, Hoeppner BB, Evins AE. Cannabis use for medical symptoms: Patterns over the first year of use. Addict Behav. 2023 Sep;144:107719. doi: 10.1016/j.addbeh.2023.107719. Epub 2023 Apr 13.
Derived from this study: PubMed 36638745Tervo-Clemmens B, Schmitt W, Wheeler G, Cooke ME, Schuster RM, Hickey S, Pachas GN, Evins AE, Gilman JM. Cannabis use and sleep quality in daily life: An electronic daily diary study of adults starting cannabis for health concerns. Drug Alcohol Depend. 2023 Feb 1;243:109760. doi: 10.1016/j.drugalcdep.2022.109760. Epub 2022 Dec 29.
Derived from this study: PubMed 35302633Gilman 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jodi M Gilman, PhD principal investigator

Assistant Professor

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Medical Marijuana in people with Pain and Insomnia, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Difference in Number of Cannabis Use Disorder Symptoms Averaged Over 2, 4, and 12 Weeks (time frame: 2 weeks, 4 weeks, and 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03224468, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.