Drug Abuse, Healthy
Conditions
Keywords
Abuse potential
Brief summary
The purpose of this study is to evaluate the abuse potential of lorcaserin in healthy recreational polydrug users.
Interventions
DRUGLorcaserin Dose #3
DRUGPlacebo
DRUGActive Comparator #2
DRUGActive Comparator #3
DRUGLorcaserin Dose #1
DRUGLorcaserin Dose #2
Sponsors
Eisai Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the abuse potential of lorcaserin | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of lorcaserin | — |
Countries
Canada
Outcome results
None listed