Medical Marijuana
Patients in this group can choose when, where, and how much medical marijuana to use.
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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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2023-11-15
What this record can show
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Registry facts
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.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Research network
Interventions
Patients in this group can choose when, where, and how much medical marijuana to use.
CannabisSource-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Medical Marijuana Arm | 105 | 0.39 | 0.78 |
| Waitlist Control Arm | 81 | 0.12 | 0.48 |
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.
Eligibility
primary outcomes
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.
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.
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.
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.
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.
secondary outcomes
Time frame: 2 weeks, 4 weeks, 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.
Time frame: 2 weeks, 4 weeks, 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.
Time frame: 4 weeks 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.
Time frame: 4 weeks and 12 weeks
Publications
Population: 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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Medical Marijuana Arm | 46 | 5.4 | 4.3 |
| Waitlist Control Arm | 37 | 5.0 | 3.9 |
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.
Population: 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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Medical Marijuana Arm | 46 | 8.4 | 4.4 |
| Waitlist Control Arm | 37 | 8.4 | 3.8 |
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.
Population: 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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Medical Marijuana Arm | 37 | 2.7 | 2.3 |
| Waitlist Control Arm | 24 | 3.3 | 2.5 |
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.
Population: The analysis is restricted to the subset of 42 participants out of 186 total who intended to use medical marijuana to address concerns for insomnia.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Medical Marijuana Arm | 22 | 8.8 | 4.7 |
| Waitlist Control Arm | 20 | 11.6 | 3.7 |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Medical Marijuana Arm | 105 | 47.1 | 11.0 |
| Waitlist Control Arm | 81 | 48.2 | 11.8 |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Medical Marijuana Arm | 105 | 44.9 | 11.7 |
| Waitlist Control Arm | 81 | 41.5 | 12.3 |
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.
Population: The analysis is restricted to the subset of 162 participants out of 186 total who completed the AST module of the CANTAB at weeks 4 and 12.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Medical Marijuana Arm | 95 | 63 | 43 |
| Waitlist Control Arm | 67 | 77 | 50 |
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.
Population: The analysis is restricted to the subset of 162 participants out of 186 total who completed the AST module of the CANTAB at weeks 4 and 12.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Medical Marijuana Arm | 95 | 139 | 90 |
| Waitlist Control Arm | 67 | 162 | 107 |
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.
Population: The analysis is restricted to the subset of 177 participants out of 186 total who completed the RVP module of the CANTAB at weeks 4 and 12.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Medical Marijuana Arm | 101 | 0.076 | 0.047 |
| Waitlist Control Arm | 76 | 0.058 | 0.044 |
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.
Population: The analysis is restricted to the subset of 177 participants out of 186 total who completed the PAL module of the CANTAB at weeks 4 and 12.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Medical Marijuana Arm | 101 | 9.1 | 11.3 |
| Waitlist Control Arm | 76 | 9.3 | 11.6 |
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.
Population: The analysis is restricted to the subset of 177 participants out of 186 total who completed the ? module of the CANTAB at weeks 4 and 12.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Medical Marijuana Arm | 101 | 26.4 | 18.4 |
| Waitlist Control Arm | 76 | 30.0 | 19.8 |
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.
Population: The analysis is restricted to the subset of 171 participants out of 186 total who completed the VRM module of the CANTAB at weeks 4 and 12.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Medical Marijuana Arm | 98 | 2.6 | 0.8 |
| Waitlist Control Arm | 73 | 2.7 | 0.7 |
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.
Population: The analysis is restricted to the subset of 175 participants out of 186 total who completed the free recall VRM module of the CANTAB at weeks 4 and 12.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Medical Marijuana Arm | 101 | 8.9 | 2.7 |
| Waitlist Control Arm | 74 | 8.5 | 2.8 |
| Milestone | Medical Marijuana Arm | Waitlist Control Arm |
|---|---|---|
| STARTED | 173 | 96 |
| COMPLETED | 105 | 81 |
| NOT COMPLETED | 68 | 15 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Cardiac Ablation | Cardiac disorders | Medical Marijuana Arm: 1 / 105 · Waitlist Control Arm: 0 / 81 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Infections and infestations | Infections and infestations | Medical Marijuana Arm: 50 / 105 · Waitlist Control Arm: 31 / 81 |
| Psychiatric symptoms | Psychiatric disorders | Medical Marijuana Arm: 31 / 105 · Waitlist Control Arm: 21 / 81 |
| General disorders and conditions | General disorders | Medical Marijuana Arm: 32 / 105 · Waitlist Control Arm: 13 / 81 |
| Nervous system symptoms | Nervous system disorders | Medical Marijuana Arm: 13 / 105 · Waitlist Control Arm: 8 / 81 |
| Injury and poisoning | Injury, poisoning and procedural complications | Medical Marijuana Arm: 12 / 105 · Waitlist Control Arm: 10 / 81 |
| Gastrointestinal disorders | Gastrointestinal disorders | Medical Marijuana Arm: 14 / 105 · Waitlist Control Arm: 5 / 81 |
| Respiratory, thoracic, and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | Medical Marijuana Arm: 7 / 105 · Waitlist Control Arm: 4 / 81 |
| Musculoskeletal disorders | Musculoskeletal and connective tissue disorders | Medical Marijuana Arm: 2 / 105 · Waitlist Control Arm: 8 / 81 |
| Immune system disorders | Immune system disorders | Medical Marijuana Arm: 4 / 105 · Waitlist Control Arm: 5 / 81 |
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.
Time frame: 4 weeks 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.
Time frame: 4 weeks 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.
Time frame: 4 weeks 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.
Time frame: 4 weeks 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.
Time frame: 4 weeks 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.