- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03786224
Pilot Trial of Contingency Management for Long-Term Cannabis Abstinence
December 20, 2023 updated by: Randi Melissa Schuster, Massachusetts General Hospital
Pilot Trial on the Efficacy of Contingency Management for Six Months of Cannabis Abstinence Among Adolescents
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 19 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Abstinent
|
Six months of cannabis abstinence will be incentivized using a standard contingency management approach involving an escalating schedule of payment for abstinence and attendance.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Randi M Schuster, PhD, Massachusetts General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2019
Primary Completion (Actual)
December 6, 2019
Study Completion (Actual)
December 6, 2019
Study Registration Dates
First Submitted
December 17, 2018
First Submitted That Met QC Criteria
December 21, 2018
First Posted (Actual)
December 24, 2018
Study Record Updates
Last Update Posted (Actual)
December 21, 2023
Last Update Submitted That Met QC Criteria
December 20, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018P001848
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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