Pilot Trial of Contingency Management for Long-Term Cannabis Abstinence

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03786224
Collaborator
(none)
20
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Study Details

Study Description

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
  • Behavioral: Contingency Management
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
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
Actual Study Start Date :
Jul 1, 2019
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Continuous abstinence via progressive declines in urine THCCOOH [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 19 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Massachusetts General Hospital Boston Massachusetts United States 02114

Sponsors and Collaborators

  • Massachusetts General Hospital

Investigators

  • Principal Investigator: Randi M Schuster, PhD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Randi Melissa Schuster, Assistant Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT03786224
Other Study ID Numbers:
  • 2018P001848
First Posted:
Dec 24, 2018
Last Update Posted:
Aug 24, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 24, 2022