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Completed

NCT Number: NCT00828659

Abuse Potential of Single Doses of Lorcaserin in Healthy Recreational Polydrug Users

The purpose of this study is to evaluate the abuse potential of lorcaserin in healthy recreational polydrug users.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kendle Early Phase, Toronto

Toronto, Ontario, M5V 2T3, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

Active Comparator #1

Drug

Active Comparator #2

Drug

Active Comparator #3

Drug

Lorcaserin Dose #1

Drug

Lorcaserin Dose #2

Drug

Lorcaserin Dose #3

Drug

Primary outcomes

  1. To evaluate the abuse potential of lorcaserin

Secondary outcomes

  1. To evaluate the safety and tolerability of lorcaserin

Sponsors and collaborators

Lead sponsor

Eisai Inc.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Crossover Study to Evaluate the Abuse Potential of Single Doses of Lorcaserin in Healthy Recreational Polydrug Users

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 26, 2009
Registry last updated
Sep 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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