Clinical trial NCT03276221: Cognitive Recovery With Cannabis Abstinence Among High School-Aged Adolescents
Official title: Cognitive Recovery With Cannabis Abstinence Among High School-Aged Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cannabis Use
Cognitive Change
Adolescent Behavior
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-09-08
Enrollment: 201
Sex: ALL
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cannabis users are randomized either to 30 days of cannabis abstinence or 30 days of monitoring with no abstinence requirement. Non-users are not randomized.
Primary purpose: OTHER

Brief 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.

Detailed description: This is a 5-year randomized, longitudinal trial of cannabis abstinence designed to determine (1) if performance improves with abstinence beyond that observed with continued cannabis use, and if so, (2) when during abstinence cognitive improvement occurs, and (3) whether performance in abstinent individuals "returns" to performance levels observed in non-using peers. We hypothesized that abstinent adolescent cannabis users would have more neurocognitive improvement over four weeks compared to non-abstinent cannabis users, and performance would continuously improve throughout four weeks of abstinence. We will recruit 210 adolescents with and without regular cannabis use. Eligible cannabis users will be randomized to either a contingency management intervention which will incentivize 4 weeks of cannabis abstinence (n = 70), or non-contingent monitoring with no abstinence requirement (n = 70). All participants (including non-users; n = 70) will complete cognitive assessments, toxicology testing, self-report questionnaires and semi-structured mood and substance use interviews during the 4-week study as well as one 30-day follow-up visit. Abstinence will be indexed by decreasing levels of cannabis metabolites in urine.

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

Primary outcomes:
measure: Mean Difference in the Total Number of Errors From Paired Associates Learning (PAL) Module Averaged Over Weeks 1, 2, 3, and 4
timeFrame: 1, 2, 3, and 4 Weeks
measure: Mean Difference in First Attempt Memory Score From Paired Associates Learning (PAL) Module Averaged Over Weeks 1, 2, 3, and 4
timeFrame: 1, 2, 3, and 4 Weeks
measure: Mean Difference in Forward Span Length From Spatial Span (SSP) Module Averaged Over Weeks 1, 2, 3, and 4
timeFrame: 1, 2, 3, and 4 Weeks
measure: Mean Difference in Reverse Span Length From Spatial Span (SSP) Module Averaged Over Weeks 1, 2, 3, and 4
timeFrame: 1, 2, 3, and 4 Weeks
measure: 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
timeFrame: 1, 2, 3, and 4 Weeks
measure: 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
timeFrame: 1, 2, 3, and 4 Weeks
measure: 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
timeFrame: 1, 2, 3, and 4 Weeks
measure: 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
timeFrame: 1, 2, 3, and 4 Weeks
measure: Mean Difference in the Total Number Incorrect From the Multitasking Test (MTT) Module Averaged Over Weeks 1, 2, 3, and 4
timeFrame: 1, 2, 3, and 4 Weeks
measure: Mean Difference in the Response Latency From the Multitasking Test (MTT) Module Averaged Over Weeks 1, 2, 3, and 4
timeFrame: 1, 2, 3, and 4 Weeks
measure: Mean Difference in the Incongruency Cost From the Multitasking Test (MTT) Module Averaged Over Weeks 1, 2, 3, and 4
timeFrame: 1, 2, 3, and 4 Weeks
measure: Mean Difference in the Multitasking Cost From the Multitasking Test (MTT) Module Averaged Over Weeks 1, 2, 3, and 4
timeFrame: 1, 2, 3, and 4 Weeks
measure: 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
timeFrame: 1, 2, 3, and 4 Weeks
measure: 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
timeFrame: 1, 2, 3, and 4 Weeks
measure: Mean Difference in Stop Signal Reaction Time From Stop Signal Task (SST) Module Averaged Over Weeks 1, 2, 3, and 4
timeFrame: 1, 2, 3, and 4 Weeks
measure: Mean Difference in the Total Number of Between Errors From the Spatial Working Memory (SWM) Module Averaged Over Weeks 1, 2, 3, and 4
timeFrame: 1, 2, 3, and 4 Weeks
measure: 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
timeFrame: 1, 2, 3, and 4 Weeks
Secondary outcomes:
measure: Mean Difference in the Measure of Discriminability - A' From the Rapid Visual Information Processing (RVP) Module Averaged Over Weeks 1, 2, 3, and 4
timeFrame: 1, 2, 3, and 4 Weeks
measure: Mean Difference in the Reponse Latency for Hits From the Rapid Visual Information Processing (RVP) Module Averaged Over Weeks 1, 2, 3, and 4
timeFrame: 1, 2, 3, and 4 Weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Randi M Schuster, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cooke ME, Gilman JM, Lamberth E, Rychik N, Tervo-Clemmens B, Evins AE, Schuster RM. Assessing Changes in Symptoms of Depression and Anxiety During Four Weeks of Cannabis Abstinence Among Adolescents. Front Psychiatry. 2021 Jul 1;12:689957. doi: 10.3389/fpsyt.2021.689957. eCollection 2021.
citation: Savulich G, Rychik N, Lamberth E, Hareli M, Evins AE, Sahakian BJ, Schuster RM. Sex Differences in Neuropsychological Functioning are Domain-Specific in Adolescent and Young Adult Regular Cannabis Users. J Int Neuropsychol Soc. 2021 Jul;27(6):592-606. doi: 10.1017/S1355617720001435.
citation: Schuster RM, Gilman J, Schoenfeld D, Evenden J, Hareli M, Ulysse C, Nip E, Hanly A, Zhang H, Evins AE. One Month of Cannabis Abstinence in Adolescents and Young Adults Is Associated With Improved Memory. J Clin Psychiatry. 2018 Oct 30;79(6):17m11977. doi: 10.4088/JCP.17m11977.
citation: Schuster RM, Potter K, Lamberth E, Rychik N, Hareli M, Allen S, Broos HC, Mustoe A, Gilman JM, Pachas G, Evins AE. Alcohol substitution during one month of cannabis abstinence among non-treatment seeking youth. Prog Neuropsychopharmacol Biol Psychiatry. 2021 Apr 20;107:110205. doi: 10.1016/j.pnpbp.2020.110205. Epub 2020 Dec 9.
citation: Schuster RM, Potter K, Vandrey R, Hareli M, Gilman J, Schoenfeld D, Evins AE. Urinary 11-nor-9-carboxy-tetrahydrocannabinol elimination in adolescent and young adult cannabis users during one month of sustained and biochemically-verified abstinence. J Psychopharmacol. 2020 Feb;34(2):197-210. doi: 10.1177/0269881119872206. Epub 2019 Sep 19.