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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.
Design Overview: 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 mobile 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 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 device to a secure encrypted 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 device, and promotes abstinence from cannabis and other substances. Progressive voucher incentives will be provided for compliance with visit attendance and study procedures.
The specific aims of the project are:
The primary outcome measures are:
Secondary aims include:
The secondary outcome measures include:
The objective of the pilot is to obtain preliminary data on cannabis use patterns, tolerability of this medication, and sleep, quality of life and activity patterns in individuals with cannabis use disorder before conducting a larger trial with lorcaserin and to inform future applications of mobile sensors to cannabis use disorder treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | Experimental | All participants will receive open label lorcaserin |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lorcaserin | Drug | Open label |
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| Measure | Description | Time Frame |
|---|---|---|
| Cannabis use | urine toxicology | weeks 1-10 |
| Adherence to device | days device is worn | weeks 1-10 |
| Feasibility of implementing mobile health device in treatment trial for CUD | 5 question self-report on likability of device; eg: Question 1: did you like wearing the mobile sensor device to track your progress during treatment? Yes or No; Question 2: Would you continue to wear the mobile sensor device to track your behaviors? Yes or No; etc | assessed once at 10weeks (end of study) |
| Cannabis Use | Timeline Followback | weeks 1-10 |
| adherence to medication | number of pills taken | weeks 1- 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia Substance Treatment and Research Service | New York | New York | 10019 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39021751 | Derived | Brezing CA, Sibai M, Choi CJ, Mitra S, Mariani JJ, Naqvi N, Mahony AL, Brooks D, Pavlicova M, Levin FR. Open Label Pilot of Lorcaserin (a serotonin 2C-receptor agonist) for Cannabis Use Disorder. J Subst Use. 2024;29(4):487-494. doi: 10.1080/14659891.2023.2202760. Epub 2023 May 10. |
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| ID | Term |
|---|---|
| C506658 | lorcaserin |
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| Fitbit Charge HR |
| Other |
This is actually not an intervention- it is a tool to measure activity and sleep; all participants will be receiving one to collect data |
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