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NCT03637842 · ClinicalTrials.gov registry record · Early Phase 1
Lorcaserin for Cannabis Use Disorder
A Early Phase 1 study, sponsored by New York State Psychiatric Institute.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 5
- Enrollment target
NCT03637842 is a Early Phase 1 study that was terminated before completion, run by New York State Psychiatric Institute. The registered enrollment target is 5 participants.
The verdict
NCT03637842, a Early Phase 1 study, was terminated before completion, sponsored by New York State Psychiatric Institute.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
The primary purpose of this study is to investigate the effect of lorcaserin on reductions in cannabis use and multiple constructs of impulsivity in outpatient treatment-seeking individuals with cannabis use disorder (CUD). Additionally, the investigators will make use of the technological application of ecological momentary assessments (EMA), to collect real-time data at key time intervals during the study on participants' use of cannabis and other substances in addition to measuring impulsive traits through self-initiated, fixed and random phone prompts. This will be a 13-week randomized, double-blind, placebo-controlled trial, with week 1 focused on baseline assessments of impulsivity (through EMA in vivo and at study visits), weeks 2- 3 of medication lead-in, and week 4 targeting a reduced cannabis use/quit day through week 13. The primary aims are to (1) Examine the effect of lorcaserin compared to placebo, on reductions in cannabis use among treatment-seeking outpatients with CUD, (2) Examine the effect of lorcaserin compared to placebo on behavioral and self-report measures of impulsivity among individuals with CUD during the medication lead-in phase (weeks 2-3). The secondary aim is to examine whether reductions in impulsivity (during weeks 2-3) mediates the effect of lorcaserin on cannabis use (during weeks 8-13), if the primary hypotheses are supported. Finally, the investigators will explore the effect of lorcaserin compared to placebo on (1) drop-out rates, (2) time to discontinuation from study, (3) treatment adherence, and (4) nicotine use.
Interventions
- DRUG Placebo oral capsule
- DRUG Lorcaserin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2019-08-01 |
| Est. Completion | 2020-02-29 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03637842
The ClinicalTrials.gov registry entry for NCT03637842 describes a study currently listed as terminated, categorized as Early Phase 1. The registered enrollment target is 5 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 Placebo oral capsule is the first listed.
NCT03637842 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03637842 about?
NCT03637842 is a clinical study titled "Lorcaserin for Cannabis Use Disorder". The primary purpose of this study is to investigate the effect of lorcaserin on reductions in cannabis use and multiple constructs of impulsivity in outpatient treatment-seeking individuals with cannabis use disorder (CUD). Additionally, the investigators will make use of the technological applicati...
What is the current status of trial NCT03637842?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 5 participants. The study started on 2019-08-01. Estimated completion is 2020-02-29.
What interventions are being tested in trial NCT03637842?
The interventions under investigation include: Placebo oral capsule (DRUG), Lorcaserin (DRUG).
Who is sponsoring clinical trial NCT03637842?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
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