Use of a Mobile Health Sensor in an Open Label Trial of Lorcaserin for the Treatment of Cannabis Use Disorder
Status:
Completed
Trial end date:
2019-01-17
Target enrollment:
Participant gender:
Summary
This is a 10 week, open-label, prospective study, involving 10 volunteer participants with
cannabis use disorder to test the feasibility and safety of using lorcaserin in addition to
the feasibility, likability, and utility of a mobile sensor device in cannabis users. The
study will be entirely outpatient. Upon study entry, participants will begin clinic visits at
the Substance Treatment and Research Service (STARS) clinic. All consented participants will
receive a Fitbit Charge HR device in week 1 to wear for the entire study and receive
lorcaserin beginning in week 2 for a total of 8 weeks (weeks 2-9). At the beginning of week
10 following discontinuation of lorcaserin, the participants will continue to wear the Fitbit
Charge HR device for this final week following completion of the medication trial. All
participants will visit the clinic twice weekly to provide urine toxicology on THC, report on
adverse events, complete additional assessments (outlined below), and upload de-identified
data from the Fitbit Charge HR device to the secure encrypted Fitabase database. Study
assessments will be collected at baseline, throughout the study, and 1 week following
medication discontinuation. All participants will also receive medical management, a
medication adherence focused psychosocial intervention that facilitates compliance with study
medication and other study procedures, including adherence to wearing the Fitbit Charge HR
device, and promotes abstinence from cannabis and other substances. Progressive voucher
incentives will be provided for compliance with visit attendance and study procedures.