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NCT02932215 · ClinicalTrials.gov registry record · Phase 1
Use of a Mobile Health Sensor in an Open Label Trial of Lorcaserin for the Treatment of Cannabis Use Disorder
A Phase 1 study, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT02932215 is a Phase 1 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 17 participants.
The verdict
NCT02932215, a Phase 1 study, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study 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.
Interventions
- DRUG lorcaserin
- OTHER Fitbit Charge HR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2016-10 |
| Est. Completion | 2019-01-17 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02932215
The ClinicalTrials.gov registry entry for NCT02932215 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York State Psychiatric Institute, which has 364 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which lorcaserin is the first listed.
NCT02932215 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02932215 about?
NCT02932215 is a clinical study titled "Use of a Mobile Health Sensor in an Open Label Trial of Lorcaserin for the Treatment of Cannabis Use Disorder". 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 outp...
What is the current status of trial NCT02932215?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2016-10. Estimated completion is 2019-01-17.
What interventions are being tested in trial NCT02932215?
The interventions under investigation include: lorcaserin (DRUG), Fitbit Charge HR (OTHER).
Who is sponsoring clinical trial NCT02932215?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
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