Abuse Potential of Single Doses of Lorcaserin in Healthy... | NCT00828659

NCT00828659

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Placebo	Placebo Comparator	Drug: Placebo
Active Comparator #1	Active Comparator	Drug: Active Comparator #1
Active Comparator #2	Active Comparator	Drug: Active Comparator #2
Active Comparator #3	Active Comparator	Drug: Active Comparator #3
Lorcaserin Dose #1	Experimental	Drug: Lorcaserin Dose #1
Lorcaserin Dose #2	Experimental	Drug: Lorcaserin Dose #2
Lorcaserin Dose #3	Experimental	Drug: Lorcaserin Dose #3

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug		Placebo
Active Comparator #1

Measure	Description	Time Frame
To evaluate the abuse potential of lorcaserin

Measure	Description	Time Frame
To evaluate the safety and tolerability of lorcaserin

Eligibility Module

Eligibility Criteria

INCLUSION CRITERIA

Healthy male or female subjects 18 to 55 years of age, inclusive.
Body mass index (BMI) within the range of 18 to 33 kg/m2, inclusive, and a minimum weight of at least 50 kg at Screening.
Free from any clinically significant medical or psychiatric abnormality
Recreational polydrug user with a history of psychedelic and depressant drug use,and at least one occasion of use in the past 3 months.
Female subjects must have a negative serum pregnancy test at Screening and urine pregnancy test at each admission.
Female subjects of childbearing potential must be practising abstinence or using and willing to continue using a medically acceptable form of birth control for at least 1 month after the last study drug administration. Male subjects who have female partners of childbearing potential must ensure that their partner use an acceptable method of contraception.
Willingness to take a drug that might alter perception in a controlled setting.

EXCLUSION CRITERIA

A subject will not be considered eligible to participate in this study, if any one of the following exclusion criteria is satisfied:

A history or presence of drug or alcohol dependence (excluding nicotine and caffeine).
Use of non-prescription, prescription medication or natural health products (except acetaminophen, vitamin or mineral supplements, acceptable forms of birth control, and hormone replacement) within 7 days prior to first drug administration in the qualification phase and throughout the study.
Use of SSRIs (e.g. fluoxetine, paroxetine, citalopram) within 14 days prior to first drug administration in the qualification phase and throughout the study.
History of allergy or hypersensitivity to the study drugs
Female subjects who are currently pregnant or lactating or who are planning to become pregnant within 30 days of last study drug administration
Treatment with any investigational drug within 30 days prior to first drug administration during the qualification phase.

Facility	Status	City	State	ZIP	Country	Contacts
Kendle Early Phase, Toronto		Toronto	Ontario	M5V 2T3	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21412231	Derived	Shram MJ, Schoedel KA, Bartlett C, Shazer RL, Anderson CM, Sellers EM. Evaluation of the abuse potential of lorcaserin, a serotonin 2C (5-HT2C) receptor agonist, in recreational polydrug users. Clin Pharmacol Ther. 2011 May;89(5):683-92. doi: 10.1038/clpt.2011.20. Epub 2011 Mar 16.

ID	Term
D064419	Chemically-Induced Disorders
D001523	Mental Disorders