Pilot Trial of Contingency Management for Long-Term Cannabis Abstinence

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.

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Key information

Conditions

Cannabis Use Adolescent Behavior Behavior

Age range

13 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

Continuous Abstinence Via Progressive Declines in Urine THCCOOH

Time frame: Six months

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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Pilot Trial on the Efficacy of Contingency Management for Six Months of Cannabis Abstinence Among Adolescents

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: Dec 24, 2018
Registry last updated: Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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