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

Primary Purpose

Drug Abuse, Healthy

Status

Completed

Phase

Phase 1

Locations

Canada

Study Type

Interventional

Intervention

Placebo

Active Comparator #1

Active Comparator #2

Active Comparator #3

Lorcaserin Dose #1

Lorcaserin Dose #2

Lorcaserin Dose #3

About this trial

This is an interventional other trial for Drug Abuse focused on measuring Abuse potential

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Kendle Early Phase, Toronto

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Placebo Comparator

Active Comparator

Experimental

Arm Label

Placebo

Active Comparator #1

Active Comparator #2

Active Comparator #3

Lorcaserin Dose #1

Lorcaserin Dose #2

Lorcaserin Dose #3

Arm Description

Outcomes

Primary Outcome Measures

To evaluate the abuse potential of lorcaserin

Secondary Outcome Measures

To evaluate the safety and tolerability of lorcaserin

Full Information

NCT ID

NCT00828659

First Posted

January 22, 2009

Last Updated

September 11, 2019

Sponsor

Eisai Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00828659

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Completed

Study Start Date

December 2008 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eisai Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Drug Abuse, Healthy

Keywords

Abuse potential

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

Active Comparator #1

Arm Type

Active Comparator

Arm Title

Active Comparator #2

Arm Type

Active Comparator

Arm Title

Active Comparator #3

Arm Type

Active Comparator

Arm Title

Lorcaserin Dose #1

Arm Type

Experimental

Arm Title

Lorcaserin Dose #2

Arm Type

Experimental

Arm Title

Lorcaserin Dose #3

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Type

Drug

Intervention Name(s)

Active Comparator #1

Intervention Type

Drug

Intervention Name(s)

Active Comparator #2

Intervention Type

Drug

Intervention Name(s)

Active Comparator #3

Intervention Type

Drug

Intervention Name(s)

Lorcaserin Dose #1

Intervention Type

Drug

Intervention Name(s)

Lorcaserin Dose #2

Intervention Type

Drug

Intervention Name(s)

Lorcaserin Dose #3

Primary Outcome Measure Information:

Title

To evaluate the abuse potential of lorcaserin

Secondary Outcome Measure Information:

Title

To evaluate the safety and tolerability of lorcaserin

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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 Information:

Facility Name

Kendle Early Phase, Toronto

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5V 2T3

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

21412231

Citation

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.

Results Reference

derived

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

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