N/A N=201 Randomized Other

Cognitive Recovery With Cannabis Abstinence Among High School-Aged Adolescents

Cannabis Use · Cognitive Change · Adolescent Behavior

Bottom Line

View on ClinicalTrials.gov: NCT03276221 ↗

Enrolled (actual)

201

Serious AEs

0.0%

Results posted

Feb 2024

Primary outcome: Primary: Mean Difference in the Total Number of Errors From Paired Associates Learning (PAL) Module Averaged Over Weeks 1, 2, 3, and 4 — 5.6; 6.2; 5.9 score on a scale — p=0.215

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Abstinence (Behavioral)
Age: Pediatric, Adult · 10+ yrs
Sex: All
Sponsor: Massachusetts General Hospital
Primary completion: Nov 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Difference in the Total Number of Errors From Paired Associates Learning (PAL) Module Averaged Over Weeks 1, 2, 3, and 4	5.6; 6.2; 5.9	0.215
PRIMARY Mean Difference in First Attempt Memory Score From Paired Associates Learning (PAL) Module Averaged Over Weeks 1, 2, 3, and 4	16.2; 15.8; 16.1	0.495
PRIMARY Mean Difference in Forward Span Length From Spatial Span (SSP) Module Averaged Over Weeks 1, 2, 3, and 4	7.6; 7.4; 7.6	0.050
PRIMARY Mean Difference in Reverse Span Length From Spatial Span (SSP) Module Averaged Over Weeks 1, 2, 3, and 4	6.9; 7; 6.9	0.532
PRIMARY Mean Difference in the Total Number Correct in the Immediate Recall Measure From the Verbal Recognition Memory (VRM) Module Averaged Over Weeks 1, 2, 3, and 4	7.3; 7.3; 7.7	0.226
PRIMARY Mean Difference in the Total Number Correct in the Delayed Recall Measure From the Verbal Recognition Memory (VRM) Module Averaged Over Weeks 1, 2, 3, and 4	6.5; 6.5; 7.2	0.369
PRIMARY Mean Difference in the Total Number Correct in the Immediate Recognition Condition From the Verbal Recognition Memory (VRM) Module Averaged Over Weeks 1, 2, 3, and 4	32.3; 32.4; 31.9	0.647
PRIMARY Mean Difference in the Total Number Correct in the Delayed Recognition Condition From the Verbal Recognition Memory (VRM) Module Averaged Over Weeks 1, 2, 3, and 4	30.5; 30.9; 30.3	0.511
PRIMARY Mean Difference in the Total Number Incorrect From the Multitasking Test (MTT) Module Averaged Over Weeks 1, 2, 3, and 4	7.1; 8.5; 9.1	0.312
PRIMARY Mean Difference in the Response Latency From the Multitasking Test (MTT) Module Averaged Over Weeks 1, 2, 3, and 4	474; 468; 482	0.836
PRIMARY Mean Difference in the Incongruency Cost From the Multitasking Test (MTT) Module Averaged Over Weeks 1, 2, 3, and 4	37; 40; 43	0.898
PRIMARY Mean Difference in the Multitasking Cost From the Multitasking Test (MTT) Module Averaged Over Weeks 1, 2, 3, and 4	96; 71; 81	0.068
PRIMARY Mean Difference in Number of Problems Correctly Solved on the First Choice From the One Touch Stockings of Cambridge (OTS) Module Averaged Over Weeks 1, 2, 3, and 4	12.2; 11.5; 11.5	0.150
PRIMARY Mean Difference in the Latency to First Correct Choice From the One Touch Stockings of Cambridge (OTS) Module Averaged Over Weeks 1, 2, 3, and 4	7036; 6690; 6851	0.525
PRIMARY Mean Difference in Stop Signal Reaction Time From Stop Signal Task (SST) Module Averaged Over Weeks 1, 2, 3, and 4	210; 219; 222	0.038 sig
PRIMARY Mean Difference in the Total Number of Between Errors From the Spatial Working Memory (SWM) Module Averaged Over Weeks 1, 2, 3, and 4	3.6; 4.6; 5.5	0.576
PRIMARY Mean Difference in the Participant's Strategy for 6-8 Box Conditions From the Spatial Working Memory (SWM) Module Averaged Over Weeks 1, 2, 3, and 4	5.4; 5.7; 6.1	0.296
SECONDARY Mean Difference in the Measure of Discriminability - A' From the Rapid Visual Information Processing (RVP) Module Averaged Over Weeks 1, 2, 3, and 4	0.94; 0.93; 0.92	0.650
SECONDARY Mean Difference in the Reponse Latency for Hits From the Rapid Visual Information Processing (RVP) Module Averaged Over Weeks 1, 2, 3, and 4	422; 428; 428	0.223

Summary

This study will use a randomized controlled design to test whether 30 days of cannabis abstinence, compared to 30 days of monitoring, is associated with improvements in cognitive functioning. Non-using controls will also be enrolled to determine the clinical significance of any cognitive improvements with abstinence.

Eligibility Criteria

General Inclusion Criteria for School-Aged Study Component:

Male and female adolescents from the Boston area who are between the ages of 10 and 19 (inclusive);
Have a parent or legal guardian who is able and willing to provide written informed consent for the active study phase (if under the age of 18);
Competent and willing to provide written informed assent for the active study phase (if under the age of 18);
Competent and able to provide written informed consent (if age 18 or older)
Able to communicate in English language
Able to commit to 9 study visits in approximately 60 days
No severe developmental delays (including, but not limited to, Autism Spectrum Disorder, Intellectual Disability, and Down Syndrome)
Able to safely participate in the protocol and appropriate for outpatient level of care

Cannabis-Using Group Inclusion Criteria:

Use of cannabis at least once per week on most weeks
Cannabis use reported within 7 days of both baseline visits
No immediate plan to discontinue cannabis use

Non-Using Group Inclusion Criteria:

Use of cannabis less than 5 times in lifetime
No cannabis use in the past year
No cannabis use before age 16

Exclusion Criteria for School-Aged Study Component

Passive consent for initial school-wide assessment withdrawn by parent or legal guardian or written parental consent not provided prior to screening

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03276221). 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.