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

NCT00828659 | Completed Phase 1

• 1 other identifier: APD356-013
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Drug Abuse; Healthy

Keywords

Abuse potential

Outcome Measures

Primary Outcomes (1)

• To evaluate the abuse potential of lorcaserin

Secondary Outcomes (1)

• To evaluate the safety and tolerability of lorcaserin

Study Arms (7)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Active Comparator #1

ACTIVE COMPARATOR

Drug: Active Comparator #1

Active Comparator #2

ACTIVE COMPARATOR

Drug: Active Comparator #2

Active Comparator #3

ACTIVE COMPARATOR

Drug: Active Comparator #3

Lorcaserin Dose #1

EXPERIMENTAL

Drug: Lorcaserin Dose #1

Lorcaserin Dose #2

EXPERIMENTAL

Drug: Lorcaserin Dose #2

Lorcaserin Dose #3

EXPERIMENTAL

Drug: Lorcaserin Dose #3

Interventions

Placebo DRUG

Placebo

Active Comparator #1 DRUG

Active Comparator #1

Active Comparator #2 DRUG

Active Comparator #2

Active Comparator #3 DRUG

Active Comparator #3

Lorcaserin Dose #1 DRUG

Lorcaserin Dose #1

Lorcaserin Dose #2 DRUG

Lorcaserin Dose #2

Lorcaserin Dose #3 DRUG

Lorcaserin Dose #3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (1)

Kendle Early Phase, Toronto

Toronto, Ontario, M5V 2T3, Canada

Location

Related Publications (1)

• 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.

  PMID: 21412231 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2009
• First Posted: January 26, 2009
• Study Start: December 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: September 12, 2019

Record last verified: 2009-07

Locations

CA (1)