Cognitive Recovery With Cannabis Abstinence Among High School-Aged Adolescents

NCT03276221 | Completed Results

• 1 other identifier: 1K23DA042946
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

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.

Conditions

Cannabis Use; Cognitive Change; Adolescent Behavior

Outcome Measures

Primary Outcomes (17)

• Mean Difference in the Total Number of Errors From Paired Associates Learning (PAL) Module Averaged Over Weeks 1, 2, 3, and 4

  The number of times the subject chose the incorrect box for a stimulus on assessment problems plus an adjustment for the estimated number of errors they would have made on any problems/attempts/recalls they did not reach. This is a specific measure from the Paired Associates Learning (PAL) module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The PAL module assesses visual memory and new learning. Count variable, ranging from 0 to 70, where higher scores indicate more errors and worse performance.

  1, 2, 3, and 4 Weeks

• Mean Difference in First Attempt Memory Score From Paired Associates Learning (PAL) Module Averaged Over Weeks 1, 2, 3, and 4

  The number of times a subject chose the correct box on their first attempt when recalling pattern locations, which was calculated across all trials. This is a specific measure from the Paired Associates Learning (PAL) module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The PAL module assesses visual memory and new learning. Count variable, ranging from 0 to 20, where higher scores indicate better memory performance.

  1, 2, 3, and 4 Weeks

• Mean Difference in Forward Span Length From Spatial Span (SSP) Module Averaged Over Weeks 1, 2, 3, and 4

  The longest length of sequences (spans) a subject successfully remembered in the original order. This is a specific measure from the Spatial Span (SSP) Module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The SSP assesses visuospatial working memory capacity. Count variable, ranging from 2 to 9, with higher scores indicating better memory performance.

  1, 2, 3, and 4 Weeks

• Mean Difference in Reverse Span Length From Spatial Span (SSP) Module Averaged Over Weeks 1, 2, 3, and 4

  The longest length of sequences (spans) a subject successfully remembered in the reverse order. This is a specific measure from the Spatial Span (SSP) Module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The SSP assesses visuospatial working memory capacity. Count variable, ranging from 2 to 9, with higher scores indicating better memory performance.

  1, 2, 3, and 4 Weeks

• 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

  The total number of distinct words a subject correctly recalled from the studied list of 18 words during the immediate free recall phase. This is a specific measure from the Verbal Recognition Memory (VRM) Module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The VRM module assesses verbal memory and new learning. Count variable, ranging from 0 to 18, with higher scores indicating better immediate recall performance.

  1, 2, 3, and 4 Weeks

• 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

  The total number of distinct words a subject correctly recalled from the studied list of 18 words during the delayed free recall phase. This is a specific measure from the Verbal Recognition Memory (VRM) Module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The VRM module assesses verbal memory and new learning. Count variable, ranging from 0 to 18, with higher scores indicating better immediate recall performance.

  1, 2, 3, and 4 Weeks

• 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

  The total number of words a subject correctly identified as either previously studied or novel during the immediate recognition phase. This is a specific measure from the Verbal Recognition Memory (VRM) Module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The VRM module assesses verbal memory and new learning. Count variable, ranging from 0 to 36, with higher scores indicating better recognition memory performance.

  1, 2, 3, and 4 Weeks

• 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

  The total number of words a subject correctly identified as either previously studied or novel during the delayed recognition phase. This is a specific measure from the Verbal Recognition Memory (VRM) Module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The VRM module assesses verbal memory and new learning. Count variable, ranging from 0 to 36, with higher scores indicating better recognition memory performance.

  1, 2, 3, and 4 Weeks

• Mean Difference in the Total Number Incorrect From the Multitasking Test (MTT) Module Averaged Over Weeks 1, 2, 3, and 4

  The total number of words a subject correctly identified as either previously studied or novel during the delayed recognition phase. This is a specific measure from the Multitasking Test (MTT) module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The MTT assesses the participant's ability to manage conflicting information provided by the direction of an arrow and its location on the screen and to ignore task-irrelevant information. Count variable, ranging from 0 to 160, with higher scores indicating more errors and worse performance.

  1, 2, 3, and 4 Weeks

• Mean Difference in the Response Latency From the Multitasking Test (MTT) Module Averaged Over Weeks 1, 2, 3, and 4

  The response latency for each participant was defined as a summary (median) computed over their response times for all correct responses irrespective of condition. This is a specific measure from the Multitasking Test (MTT) module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The MTT assesses the participant's ability to manage conflicting information provided by the direction of an arrow and its location on the screen and to ignore task-irrelevant information. Response time variable in milliseconds (ms), ranging from 100 to 2000 ms, with higher values indicating slower performance across all trials.

  1, 2, 3, and 4 Weeks

• Mean Difference in the Incongruency Cost From the Multitasking Test (MTT) Module Averaged Over Weeks 1, 2, 3, and 4

  The incongruency cost for each participant was defined as a summary (median) of response times for incongruent trials minus a summary (median) of response times for congruent trials. This is a specific measure from the Multitasking Test (MTT) module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The MTT assesses the participant's ability to manage conflicting information provided by the direction of an arrow and its location on the screen and to ignore task-irrelevant information. Difference score in milliseconds (ms), ranging from -1900 to 1900 ms, with higher values indicating slower responses on incongruent trials, suggesting that it takes longer to process conflicting information.

  1, 2, 3, and 4 Weeks

• Mean Difference in the Multitasking Cost From the Multitasking Test (MTT) Module Averaged Over Weeks 1, 2, 3, and 4

  The multitasking cost for each participant was defined as a summary (median) of response times for the multi-task blocks (trials alternated between having to respond to the direction or position of the arrow) minus a summary (median) of response times for the single-task blocks (all trials consisted of either responding to the direction or position of the arrow). This is a specific measure from the Multitasking Test (MTT) module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The MTT assesses the participant's ability to manage conflicting information provided by the direction of an arrow and its location on the screen and to ignore task-irrelevant information. Difference score in milliseconds (ms), ranging from -1900 to 1900 ms, with higher values indicating slower responses on multi-task blocks, suggesting that it takes longer to process multiple sources of information.

  1, 2, 3, and 4 Weeks

• 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

  The total number of trials where the subject chose the correct answer on the first attempt. This is a specific measure from the One Touch Stockings of Cambridge (OTS) Module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The OTS module assesses executive function based upon the Tower of Hanoi test. Count variable, ranging from 0 to 15, with higher scores indicating better performance.

  1, 2, 3, and 4 Weeks

• 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

  The latency to first correct choice for each participant was defined as a summary (median) of the response times for all trials in which the subject picked the correct choice on the first attempt. This is a specific measure from the One Touch Stockings of Cambridge (OTS) Module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The OTS module assesses executive function based upon the Tower of Hanoi test. Response time variable in milliseconds (ms), a positive unbounded variable, with higher values indicating slower performance across correct trials.

  1, 2, 3, and 4 Weeks

• Mean Difference in Stop Signal Reaction Time From Stop Signal Task (SST) Module Averaged Over Weeks 1, 2, 3, and 4

  The estimate of the duration at which a person can successfully inhibit a response 50% of the time, represents the time before which all actions become ballistic and a subject is unable to cancel a response selection. This is a specific measure from the Stop Signal Task (SST) Module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The SST module assesses response inhibition (impulse control). Response time variable in milliseconds (ms), ranging from 0 to 500 ms, with higher values indicating that it takes longer for a person to inhibit a response.

  1, 2, 3, and 4 Weeks

• Mean Difference in the Total Number of Between Errors From the Spatial Working Memory (SWM) Module Averaged Over Weeks 1, 2, 3, and 4

  The number of times a subject incorrectly revisited a box that had contained a token in a previous trial across the 4, 6, and 8 box conditions. This is a specific measure from the Spatial Working Memory (SWM) module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The SWM module provides a measure of strategy as well as working memory errors. Count variable, ranging from 0 to 63, with higher scores indicating worse performance.

  1, 2, 3, and 4 Weeks

• 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

  The number of times subjects began a new search from the same box they started on in previous trials. It is assumed that a person who begins from the same box each time is using a planned strategy to find the tokens. This is a specific measure from the Spatial Working Memory (SWM) module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The SWM module provides a measure of strategy as well as working memory errors. Count variable, ranging from 2 to 14, with higher scores indicating low strategy, meaning a subject began searches from many different boxes.

  1, 2, 3, and 4 Weeks

Secondary Outcomes (2)

• Mean Difference in the Measure of Discriminability - A' From the Rapid Visual Information Processing (RVP) Module Averaged Over Weeks 1, 2, 3, and 4

  1, 2, 3, and 4 Weeks

• Mean Difference in the Reponse Latency for Hits From the Rapid Visual Information Processing (RVP) Module Averaged Over Weeks 1, 2, 3, and 4

  1, 2, 3, and 4 Weeks

Study Arms (3)

Abstinent

ACTIVE COMPARATOR

This group of cannabis users are agree to remain abstinent from cannabis use for 30 days.

Behavioral: Abstinence

Monitoring

NO INTERVENTION

This group of cannabis users are not asked to change their cannabis use behavior.

Non-Users

NO INTERVENTION

This is a group of adolescents with little to no cannabis use history and is non-randomized.

Interventions

Abstinence BEHAVIORAL

Cannabis users randomized to this condition will be enrolled in a contingency management intervention for 30 days of cannabis abstinence.

Also known as: Contingency Management

Abstinent

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (5)

• 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.

  PMID: 34276449 RESULT

• 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.

  PMID: 34261559 RESULT

• 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.

  PMID: 30408351 RESULT

• 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.

  PMID: 33309538 RESULT

• 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.

  PMID: 31535597 RESULT

MeSH Terms

Conditions

Adolescent Behavior

Interventions

Natural Family Planning Methods

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Contraception; Reproductive Techniques; Therapeutics

Limitations and Caveats

Due to the constraints of the COVID-19 pandemic, approximately 6% of all study visits were conducted virtually. Visits were conducted remotely for one of the following reasons: the study site was closed due to hospital policy, the participant tested positive for COVID-19, or they endorsed a COVID-19-related symptom before the study visit. We believe this is a minor limitation of our study since administering the cognitive assessments virtually could have affected data collection.

Results Point of Contact

• Title: Randi M. Schuster, PhD
• Organization: Massachusetts General Hospital

rschuster@mgh.harvard.edu

617-643-6673

Study Officials

• Randi M Schuster, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 6, 2017
• First Posted: September 8, 2017
• Study Start: August 7, 2017
• Primary Completion: November 9, 2022
• Study Completion: November 9, 2022
• Last Updated: February 1, 2024
• Results First Posted: February 1, 2024

Record last verified: 2024-01

Locations

US (1)