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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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In this study, the investigators are interested in testing how lorcaserin influences the effects of cannabis in a human laboratory model of cannabis use.
In order to improve treatment outcome for cannabis use disorder (CUD), the investigators have developed a laboratory model to investigate the effects of potential treatment medications on cannabis withdrawal and on the subjective and reinforcing effects of cannabis in non treatment-seeking cannabis smokers. In this study, the investigators are interested in testing how lorcaserin influences the effects of cannabis in a human laboratory model of cannabis use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lorcaserin + Marijuana | Experimental |
| |
| Placebo + Marijuana | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lorcaserin | Drug | Lorcaserin 10mg BID |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Cannabis Self-administration | Number of cannabis puffs participant chooses to smoke. | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
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Participants were enrolled in this study comprising two 13-day inpatient phases, each of which was preceded by two medication administration outpatient days to achieve steady-state levels prior to key behavioral measures. Each phase tested a different medication condition (lorcaserin 10 mg or placebo BID) in a within-subject design, with at least one medication-free week between phases to allow for medication clearance.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lorcaserin + Marijuana First, Then Placebo + Marijuana | Lorcaserin: Lorcaserin 10mg or 0mg BID Marijuana: Smoked marijuana cigarette |
| FG001 | Placebo + Marijuana First, Then Lorcaserin + Marijuana | Lorcaserin: Lorcaserin 10mg or 0mg BID Marijuana: Smoked marijuana cigarette |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lorcaserin + Marijuana | Lorcaserin: Lorcaserin 10mg or 0mg BID Marijuana: Smoked marijuana cigarette |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cannabis Self-administration | Number of cannabis puffs participant chooses to smoke. | Participants were randomly counterbalanced into each condition, such that all participants contributed to all conditions. | Posted | Mean | Standard Error | puffs of cannabis chosen | 14 days |
|
Data reflect the number of participants reporting an adverse event during the inpatient phase (11 days) as a function of lorcaserin dose (0 mg or 10 mg BID). No serious adverse events were reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lorcaserin + Marijuana | Lorcaserin: Lorcaserin 10mg BID Marijuana: Smoked marijuana cigarette |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Product Issues | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Margaret Haney | New York State Psychiatric Institute | 646-774-6153 | mh235@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 12, 2018 | May 31, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 29, 2022 | Jul 25, 2022 | SAP_004.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 9, 2017 | May 31, 2022 | ICF_002.pdf |
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| ID | Term |
|---|---|
| C506658 | lorcaserin |
| C587251 | nabiximols |
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| Drug |
Placebo capsule BID |
|
| Marijuana | Drug | Smoked marijuana cigarette |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 15 |
| 15 |
| EG001 | Placebo + Marijuana | Placebo: Placebo capsule BID Marijuana: Smoked marijuana cigarette | 0 | 15 | 0 | 15 | 8 | 15 |
| Gastrointestinal upset | Product Issues | Systematic Assessment |
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| Body pain | Product Issues | Systematic Assessment |
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| Anxiety/Jittery | Product Issues | Systematic Assessment |
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| Eye dryness/discomfort | Product Issues | Systematic Assessment |
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| Trouble sleeping | Product Issues | Systematic Assessment |
|
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