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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: Clinical Trial Early Phase 1 study, sponsored by New York State Psychiatric Institute.
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, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
descriptive of cannabis use per day captured in daily quartiles based on self report as collected by the Time Line Follow back. The quartiles defined as follows: 12AM-6AM; 6AM-12PM; 12PM-6PM;6PM-12AM. Participants would report if they used during each of these times.
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 |
Why NCT03637842 stopped before completion
NCT03637842 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo oral capsule is the first listed.
NCT03637842 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03637842's enrollment target sits among peer trials
5 1887th of 2000 higher than 80 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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