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Cognitive Recovery With Cannabis Abstinence Among High School-Aged Adolescents

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ClinicalTrials.gov Identifier: NCT03276221
Recruitment Status : Recruiting
First Posted : September 8, 2017
Last Update Posted : September 8, 2017
Sponsor:
Information provided by (Responsible Party):
Randi Melissa Schuster, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Cannabis Use Cognitive Change Adolescent Behavior Behavioral: Abstinence Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Other
Official Title: Cognitive Recovery With Cannabis Abstinence Among High School-Aged Adolescents
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
Active Comparator: Abstinent
This group of cannabis users are agree to remain abstinent from cannabis use for 30 days.
Behavioral: Abstinence
Cannabis users randomized to this condition will be enrolled in a contingency management intervention for 30 days of cannabis abstinence.
Other Name: Contingency Management

No Intervention: Monitoring
This group of cannabis users are not asked to change their cannabis use behavior.
No Intervention: Non-Users
This is a group of adolescents with little to no cannabis use history and is non-randomized.



Primary Outcome Measures :
  1. Change in Memory Measured with the CANTAB [ Time Frame: From Baseline to 30 days ]
  2. Change in Attention Measured with the CANTAB [ Time Frame: From Baseline to 30 days ]

Secondary Outcome Measures :
  1. Change in Executive Functioning Measured with the CANTAB [ Time Frame: From Baseline to 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03276221


Contacts
Contact: Randi M Schuster, PhD 617-643-6673 Rschuster@mgh.harvard.edu

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Randi M Schuster, PhD    617-643-6673    Rschuster@mgh.harvard.edu   
Principal Investigator: Randi M Schuster, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Randi M Schuster, PhD Massachusetts General Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Randi Melissa Schuster, Fellow, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03276221     History of Changes
Other Study ID Numbers: 1K23DA042946 ( U.S. NIH Grant/Contract )
First Posted: September 8, 2017    Key Record Dates
Last Update Posted: September 8, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders