N/A N=269 Randomized Double-blind Treatment

Effect of Medical Marijuana on Neurocognition and Escalation of Use

Pain · Insomnia · Depression · Anxiety

Bottom Line

View on ClinicalTrials.gov: NCT03224468 ↗

Enrolled (actual)

269

Serious AEs

0.5%

Results posted

Nov 2023

Primary outcome: Primary: Mean Difference in Number of Cannabis Use Disorder Symptoms Averaged Over 2, 4, and 12 Weeks — 0.39; 0.12 score on a scale — p=<0.001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Medical Marijuana (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Massachusetts General Hospital
Primary completion: Feb 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Difference in Number of Cannabis Use Disorder Symptoms Averaged Over 2, 4, and 12 Weeks	0.39; 0.12	<0.001 sig
PRIMARY Mean Difference in Depression Subscale Scores From the HADS Averaged Over 2, 4, and 12 Weeks	5.4; 5.0	0.50
PRIMARY Mean Difference in Anxiety Subscale Scores From the HADS Averaged Over 2, 4, and 12 Weeks	8.4; 8.4	0.90
PRIMARY Mean Difference in Pain Severity Scores on the BPI Average Over 2, 4, and 12 Weeks	2.7; 3.3	0.93
PRIMARY Mean Difference in Sleep Scores on the AIS Averaged Over 2, 4, and 12 Weeks	8.8; 11.6	<0.001 sig
SECONDARY Mean Difference in Physical Health Scores on the SF-12 Averaged Over 2, 4, and 12 Weeks	47.1; 48.2	—
SECONDARY Mean Difference in Mental Health Scores on the SF-12 Averaged Over 2, 4, and 12 Weeks	44.9; 41.5	—
SECONDARY Mean Difference in Attention Switching Task: Congruency Cost Scores on the CANTAB Averaged Over 4 and 12 Weeks	63; 77	—
SECONDARY Mean Difference in Attention Switching Task: Switching Cost Scores on the CANTAB Averaged Over 4 and 12 Weeks	139; 162	—
SECONDARY Mean Difference in Rapid Visual Information Processing (RVP) Task: Discriminability Scores on the CANTAB Averaged Over 4 and 12 Weeks	0.076; 0.058	—
SECONDARY Mean Difference in Paired Associates Learning (PAL) Task: Total Errors Scores on the CANTAB Averaged Over 4 and 12 Weeks	9.1; 9.3	—
SECONDARY Mean Difference in Spatial Working Memory (SWM) Task: Repetition Errors Scores on the CANTAB Averaged Over 4 and 12 Weeks	26.4; 30.0	—
SECONDARY Mean Difference in Verbal Recognition Memory (VRM) Task: d' Scores on the CANTAB Averaged Over 4 and 12 Weeks	2.6; 2.7	—
SECONDARY Mean Difference in Verbal Recognition Memory (VRM) Task: Free Recall Memory Scores on the CANTAB Averaged Over 4 and 12 Weeks	8.9; 8.5	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03224468). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.