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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00828659
• Other study ID #: APD356-013
• Status: Completed
• Phase: Phase 1
• Start date: December 2008
• Est. completion date: April 2009

Study information

• Verified date: July 2009
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

INCLUSION CRITERIA

1. Healthy male or female subjects 18 to 55 years of age, inclusive.

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

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

1. A history or presence of drug or alcohol dependence (excluding nicotine and caffeine).

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.

Related Conditions & MeSH terms

• Drug Abuse
• Healthy
• Substance-Related Disorders

Intervention

Drug:
• Placebo

• Active Comparator #1

• Active Comparator #2

• Active Comparator #3

• Lorcaserin Dose #1

• Lorcaserin Dose #2

• Lorcaserin Dose #3

Locations

Country	Name	City	State
Canada	Kendle Early Phase, Toronto	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the abuse potential of lorcaserin
Secondary	To evaluate the safety and tolerability of lorcaserin