Cognitive Recovery With Cannabis Abstinence Among High School-Aged Adolescents

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-07

Study Completion Date

2022-11-09

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.

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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.

Conditions

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Cannabis Use Cognitive Change Adolescent Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Abstinent

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

Group Type ACTIVE_COMPARATOR

Abstinence

Intervention Type BEHAVIORAL

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

Monitoring

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Non-Users

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Abstinence

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Contingency Management

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

\- Passive consent for initial school-wide assessment withdrawn by parent or legal guardian or written parental consent not provided prior to screening

Minimum Eligible Age

10 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes