Cognitive Recovery With Cannabis Abstinence Among High School-Aged Adolescents

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cognitive Recovery With Cannabis Abstinence Among High School-Aged Adolescents

Conditions
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Cannabis Use, Cognitive Change, Adolescent Behavior

Intervention / Treatment
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* Behavioral: Abstinence


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Abstinent<br>This group of cannabis users are agree to remain abstinent from cannabis use for 30 days. | Behavioral: Abstinence<br>* Cannabis users randomized to this condition will be enrolled in a contingency management intervention for 30 days of cannabis abstinence.<br>* Other names: Contingency Management;|
| No Intervention: Monitoring<br>This group of cannabis users are not asked to change their cannabis use behavior. | |
| No Intervention: Non-Users<br>This is a group of adolescents with little to no cannabis use history and is non-randomized. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Memory Measured with the CANTAB |  | From Baseline to 30 days | 
| Change in Attention Measured with the CANTAB |  | From Baseline to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Executive Functioning Measured with the CANTAB |  | From Baseline to 30 days |