Abuse Potential of Single Doses of Lorcaserin in Healthy Recreational Polydrug Users
NCT ID: NCT00828659
Last Updated: 2019-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
35 participants
INTERVENTIONAL
2008-12-31
2009-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
DOUBLE
Study Groups
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Placebo
Placebo
Active Comparator #1
Active Comparator #1
Active Comparator #2
Active Comparator #2
Active Comparator #3
Active Comparator #3
Lorcaserin Dose #1
Lorcaserin Dose #1
Lorcaserin Dose #2
Lorcaserin Dose #2
Lorcaserin Dose #3
Lorcaserin Dose #3
Interventions
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Placebo
Active Comparator #1
Active Comparator #2
Active Comparator #3
Lorcaserin Dose #1
Lorcaserin Dose #2
Lorcaserin Dose #3
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Free from any clinically significant medical or psychiatric abnormality
4. Recreational polydrug user with a history of psychedelic and depressant drug use,and at least one occasion of use in the past 3 months.
5. Female subjects must have a negative serum pregnancy test at Screening and urine pregnancy test at each admission.
6. 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.
7. Willingness to take a drug that might alter perception in a controlled setting.
Exclusion Criteria
2. 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.
3. Use of SSRIs (e.g. fluoxetine, paroxetine, citalopram) within 14 days prior to first drug administration in the qualification phase and throughout the study.
4. History of allergy or hypersensitivity to the study drugs
5. Female subjects who are currently pregnant or lactating or who are planning to become pregnant within 30 days of last study drug administration
6. Treatment with any investigational drug within 30 days prior to first drug administration during the qualification phase.
18 Years
55 Years
ALL
Yes
Sponsors
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Eisai Inc.
INDUSTRY
Responsible Party
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Locations
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Kendle Early Phase, Toronto
Toronto, Ontario, Canada
Countries
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References
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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.
Other Identifiers
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APD356-013
Identifier Type: -
Identifier Source: org_study_id
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