Effect of Medical Marijuana on Neurocognition and Escalation of Use

NCT03224468 | Completed Results

• 1 other identifier: 2015P001600
• Study Type: interventional
• Target: 269
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Insomnia; Depression; Anxiety

Keywords

medical marijuana; cannabis; pain; insomnia; depression; anxiety; addiction; dependence; neurocognition; MRI

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  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

  2 weeks, 4 weeks, and 12 weeks

• Mean Difference in Mental Health Scores on the SF-12 Averaged Over 2, 4, and 12 Weeks

  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

  4 weeks and 12 weeks

• Mean Difference in Attention Switching Task: Switching Cost Scores on the CANTAB Averaged Over 4 and 12 Weeks

  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

  4 weeks and 12 weeks

Study Arms (2)

Medical Marijuana Arm

ACTIVE COMPARATOR

This group can begin using medical marijuana immediately.

Drug: Medical Marijuana

Waitlist Control Arm

NO INTERVENTION

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

Interventions

Medical Marijuana DRUG

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

Also known as: Cannabis

Medical Marijuana Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Participant eligibility is based on self-representation of gender identity.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (6)

• 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.

  PMID: 38746368 DERIVED

• 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.

  PMID: 37625034 DERIVED

• 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.

  PMID: 37289502 DERIVED

• 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.

  PMID: 37068366 DERIVED

• 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.

  PMID: 36638745 DERIVED

• 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.

  PMID: 35302633 DERIVED

MeSH Terms

Conditions

Pain; Sleep Initiation and Maintenance Disorders; Depression; Anxiety Disorders; Marijuana Abuse; Behavior, Addictive

Interventions

Medical Marijuana; nabiximols

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Compulsive Behavior; Impulsive Behavior

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Limitations and Caveats

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.

Results Point of Contact

• Title: Jodi Gilman, PhD
• Organization: Massachusetts General Hospital

jgilman1@mgh.harvard.edu

617-643-7293

Study Officials

• Jodi M Gilman, PhD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 17, 2017
• First Posted: July 21, 2017
• Study Start: July 1, 2017
• Primary Completion: February 5, 2021
• Study Completion: November 1, 2022
• Last Updated: November 15, 2023
• Results First Posted: November 15, 2023

Record last verified: 2023-02

Locations

US (1)