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Trial record 27 of 95 for:    Recruiting, Not yet recruiting, Active, not recruiting Studies | marijuana | United States

Pilot Trial of Contingency Management for Long-Term Cannabis Abstinence

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ClinicalTrials.gov Identifier: NCT03786224
Recruitment Status : Not yet recruiting
First Posted : December 24, 2018
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Randi Melissa Schuster, Massachusetts General Hospital

Brief Summary:
This study is a critically important first-of-its-kind investigation of the potential research utility of using contingency management to examine long-term changes in cannabis use with six months of abstinence. These pilot data will inform a later trial which will focus on testing the longitudinal relationships between adolescent cognition and cannabis use, questions of high and growing public health significance given adolescents' increased access to cannabis with legalization.

Condition or disease Intervention/treatment Phase
Cannabis Use Adolescent Behavior Behavioral: Contingency Management Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pilot Trial on the Efficacy of Contingency Management for Six Months of Cannabis Abstinence Among Adolescents
Estimated Study Start Date : July 1, 2019
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
Experimental: Abstinent Behavioral: Contingency Management
Six months of cannabis abstinence will be incentivized using a standard contingency management approach involving an escalating schedule of payment for abstinence and attendance.




Primary Outcome Measures :
  1. Continuous abstinence via progressive declines in urine THCCOOH [ Time Frame: Six months ]
    Cannabis abstinence will be indexed by progressively decreasing quantitative levels of 11-nor-delta-9-THC-9-carboxylic acid (THCCOOH), the primary cannabis metabolite, in urine. Residual cannabinoid excretion will be differentiated from new cannabis exposure using a statistical model developed by Schwilke and colleagues (2011). This model was empirically derived from urine CN-THCCOOH concentration ratios of consecutively collected specimen pairs (current specimen/prior specimen). This model takes into account the time between collection of specimens, which enhances the accuracy of prediction of new cannabis use. This formula yields an expected CN-THCCOOH ratio associated with specimen pairs during abstinence, and observed ratios that exceed this expected value are interpreted as new cannabis use.



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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

Inclusion Criteria:

  • Male and female adolescents actively enrolled in a middle or high school in the Boston area who are between the ages of 13 and 19 (inclusive);
  • Average use of cannabis at least 3 times per week during the 3 months prior to study enrollment;
  • Cannabis use reported within 7 days of study enrollment;
  • No immediate plan to discontinue cannabis use;
  • Have a parent or legal guardian who is competent 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 willing to provide written informed consent (if age 18 or older);
  • Able to communicate in English language;
  • Have a parent/guardian who can communicate in English language;
  • Able to commit to 27 study visits in approximately 6 months;
  • Able to safely participate in the protocol and appropriate for outpatient level of care, in the opinion of the investigator.

Exclusion Criteria:

- Any severe developmental delays (including, but not limited to, Autism Spectrum Disorder, Intellectual Disability, and Down Syndrome).


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): NCT03786224


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

Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Randi M Schuster, PhD Massachusetts General Hospital

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Responsible Party: Randi Melissa Schuster, Assistant Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03786224     History of Changes
Other Study ID Numbers: 2018P001848
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019

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

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