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Cognitive Recovery With Cannabis Abstinence Among High School-Aged Adolescents

Primary Purpose

Cannabis Use, Cognitive Change, Adolescent Behavior

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Abstinence
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cannabis Use

Eligibility Criteria

13 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

General Inclusion Criteria:

  • Male and female adolescents from the Boston area who are between the ages of 13 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

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

Non-Using Group Inclusion Criteria:

- Use of cannabis less than 5 times in lifetime

General Exclusion Criteria:

  • 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.

Non-Using Group Exclusion Criteria:

  • No cannabis use in the past year
  • No cannabis use before age 16

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

No Intervention

Arm Label

Abstinent

Monitoring

Non-Users

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Change in Memory Measured with the CANTAB
Change in Attention Measured with the CANTAB

Secondary Outcome Measures

Change in Executive Functioning Measured with the CANTAB

Full Information

First Posted
September 6, 2017
Last Updated
May 23, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03276221
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 7, 2017 (Actual)
Primary Completion Date
November 9, 2022 (Actual)
Study Completion Date
November 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use, Cognitive Change, Adolescent Behavior

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
238 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Abstinent
Arm Type
Active Comparator
Arm Description
This group of cannabis users are agree to remain abstinent from cannabis use for 30 days.
Arm Title
Monitoring
Arm Type
No Intervention
Arm Description
This group of cannabis users are not asked to change their cannabis use behavior.
Arm Title
Non-Users
Arm Type
No Intervention
Arm Description
This is a group of adolescents with little to no cannabis use history and is non-randomized.
Intervention Type
Behavioral
Intervention Name(s)
Abstinence
Other Intervention Name(s)
Contingency Management
Intervention Description
Cannabis users randomized to this condition will be enrolled in a contingency management intervention for 30 days of cannabis abstinence.
Primary Outcome Measure Information:
Title
Change in Memory Measured with the CANTAB
Time Frame
From Baseline to 30 days
Title
Change in Attention Measured with the CANTAB
Time Frame
From Baseline to 30 days
Secondary Outcome Measure Information:
Title
Change in Executive Functioning Measured with the CANTAB
Time Frame
From Baseline to 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
General Inclusion Criteria: Male and female adolescents from the Boston area who are between the ages of 13 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 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 Non-Using Group Inclusion Criteria: - Use of cannabis less than 5 times in lifetime General Exclusion Criteria: 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. Non-Using Group Exclusion Criteria: No cannabis use in the past year No cannabis use before age 16
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randi M Schuster, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31535597
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.
Results Reference
derived
PubMed Identifier
30408351
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.
Results Reference
derived

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Cognitive Recovery With Cannabis Abstinence Among High School-Aged Adolescents

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