Cognitive Recovery With Cannabis Abstinence Among High School-Aged Adolescents

Mass General Brigham

Status: Completed

Conditions: Cognitive Change; Cannabis Use; Adolescent Behavior

Treatments: Behavioral: Abstinence

Study type: Interventional

Funder types: Other

Identifiers

NCT03276221

1K23DA042946

Details and patient eligibility

About

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.

Full 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.

Enrollment: 201 patients

Sex: All

Ages: 10 to 19 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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201 participants in 3 patient groups

Abstinent

Active Comparator group

Description:

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

Treatment:

Behavioral: Abstinence

Monitoring

No Intervention group

Description:

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

Non-Users

No Intervention group

Description:

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