Adolescent Behavior, Cannabis Use
Conditions
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.
Interventions
BEHAVIORALContingency 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.
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 19 Years
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Continuous Abstinence Via Progressive Declines in Urine THCCOOH | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Abstinent 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. | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Abstinent |
|---|---|
| Age, Continuous | 19 years STANDARD_DEVIATION 1.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 4 Participants |
| Urine THCCOOH | 281.9 ng/mL STANDARD_DEVIATION 262.6 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 5 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
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.
Time frame: Six months
Population: 6 subjects enrolled in this pilot study and were included in the analysis. However, no participants completed data collection at the 6-month time point.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Abstinent | Continuous Abstinence Via Progressive Declines in Urine THCCOOH | NA ng/mL |