Effect of Lorcaserin on Cannabis Withdrawal and Self-administration
1 other identifier
interventional
15
1 country
1
Brief Summary
In this study, the investigators are interested in testing how lorcaserin influences the effects of cannabis in a human laboratory model of cannabis use.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Sep 2017
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2017
CompletedFirst Posted
Study publicly available on registry
August 18, 2017
CompletedStudy Start
First participant enrolled
September 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedResults Posted
Study results publicly available
July 26, 2022
CompletedJuly 26, 2022
July 1, 2022
3.7 years
August 14, 2017
May 31, 2022
July 25, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Cannabis Self-administration
Number of cannabis puffs participant chooses to smoke.
14 days
Study Arms (2)
Lorcaserin + Marijuana
EXPERIMENTALPlacebo + Marijuana
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Current cannabis use
- Able to give informed consent and perform study procedures
- Women practicing an effective form of birth control
- English speaking
You may not qualify if:
- Presence of any clinically significant medical diagnoses
- History of heart disease and cardiac risk factors, severe chronic obstructive pulmonary disease, uncontrolled hypertension, or diabetes
- Current parole or probation
- Certain psychiatric diagnoses
- Current pregnancy or lactation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York State Psychiatric Institute
New York, New York, 10032, United States
MeSH Terms
Interventions
Limitations and Caveats
There are several limitations to consider in the current study. First, given the study length, only one dose of lorcaserin was tested, though it was the FDA-approved therapeutic dose for obesity and the dose shown to reduce tobacco cigarette use in a clinical study targeting this population. Second, the sample comprised mostly men, limiting the generalizability of our conclusions.
Results Point of Contact
- Title
- Margaret Haney
- Organization
- New York State Psychiatric Institute
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Neurobiology (in Psychiatry) at CUMC
Study Record Dates
First Submitted
August 14, 2017
First Posted
August 18, 2017
Study Start
September 5, 2017
Primary Completion
May 31, 2021
Study Completion
December 31, 2021
Last Updated
July 26, 2022
Results First Posted
July 26, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share