Pilot Trial of Contingency Management for Long-Term Cannabis Abstinence

NCT03786224 | Completed Results

• 1 other identifier: 2018P001848
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Cannabis Use; Adolescent Behavior

Outcome Measures

Primary Outcomes (1)

• Continuous Abstinence Via Progressive Declines in Urine THCCOOH

  Cannabis abstinence will be indexed by progressively decreasing quantitative levels (ng/mL) 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

Study Arms (1)

Abstinent

EXPERIMENTAL

Behavioral: Contingency Management

Interventions

Contingency Management BEHAVIORAL

Six months of cannabis abstinence will be incentivized using a standard contingency management approach involving an escalating schedule of payment for abstinence and attendance.

Abstinent

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Adolescent Behavior

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Randi Schuster, PhD
• Organization: Massachusetts General Hospital

rschuster@mgh.harvard.edu

617-643-6673

Study Officials

• Randi M Schuster, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 24, 2018
• Study Start: July 1, 2019
• Primary Completion: December 6, 2019
• Study Completion: December 6, 2019
• Last Updated: August 2, 2024
• Results First Posted: August 2, 2024

Record last verified: 2024-02

Locations

US (1)