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Pilot Trial of Contingency Management for Long-Term Cannabis Abstinence

Primary Purpose

Cannabis Use, Adolescent Behavior

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Contingency Management
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cannabis Use

Eligibility Criteria

13 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Abstinent

Arm Description

Outcomes

Primary Outcome Measures

Continuous abstinence via progressive declines in urine THCCOOH
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.

Secondary Outcome Measures

Full Information

First Posted
December 17, 2018
Last Updated
August 23, 2022
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03786224
Brief Title
Pilot Trial of Contingency Management for Long-Term Cannabis Abstinence
Official Title
Pilot Trial on the Efficacy of Contingency Management for Six Months of Cannabis Abstinence Among Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use, Adolescent Behavior

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Abstinent
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management
Intervention Description
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 Measure Information:
Title
Continuous abstinence via progressive declines in urine THCCOOH
Description
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.
Time Frame
Six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Randi M Schuster, PhD
Phone
617-643-6673
Email
Rschuster@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randi M Schuster, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Randi M Schuster, PhD
Phone
617-643-6673
Email
Rschuster@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Randi M Schuster, PhD

12. IPD Sharing Statement

Learn more about this trial

Pilot Trial of Contingency Management for Long-Term Cannabis Abstinence

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