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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00828659
• Date of registration: 22/01/2009
• Prospective Registration: No
• Primary sponsor: Eisai Inc.
• Public title: Abuse Potential of Single Doses of Lorcaserin in Healthy Recreational Polydrug Users
• Scientific 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
• Date of first enrolment: December 2008
• Target sample size: 35
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00828659
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

Canada

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Healthy

Drug Abuse

Intervention(s)

Drug: Active Comparator #3

Drug: Lorcaserin Dose #3

Drug: Lorcaserin Dose #1

Drug: Placebo

Drug: Active Comparator #1

Drug: Active Comparator #2

Drug: Lorcaserin Dose #2

Primary Outcome(s)

To evaluate the abuse potential of lorcaserin

Secondary Outcome(s)

To evaluate the safety and tolerability of lorcaserin

Secondary ID(s)

APD356-013

Source(s) of Monetary Support

Please refer to primary and secondary sponsors