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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy; Drug Abuse
• Intervention / Treatment: Drug: Placebo; Drug: Active Comparator #1; Drug: Active Comparator #2; Drug: Active Comparator #3; Drug: Lorcaserin Dose #1; Drug: Lorcaserin Dose #2; Drug: Lorcaserin Dose #3

• Study Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5V 2T3
      • Kendle Early Phase, Toronto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo
ACTIVE_COMPARATOR: Active Comparator #1	Drug: Active Comparator #1
ACTIVE_COMPARATOR: Active Comparator #2	Drug: Active Comparator #2
ACTIVE_COMPARATOR: Active Comparator #3	Drug: Active Comparator #3
EXPERIMENTAL: Lorcaserin Dose #1	Drug: Lorcaserin Dose #1
EXPERIMENTAL: Lorcaserin Dose #2	Drug: Lorcaserin Dose #2
EXPERIMENTAL: Lorcaserin Dose #3	Drug: Lorcaserin Dose #3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To evaluate the abuse potential of lorcaserin

Secondary Outcome Measures

Outcome Measure
To evaluate the safety and tolerability of lorcaserin

Collaborators and Investigators

• Sponsor: Eisai Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (ACTUAL): April 1, 2009
• Study Completion (ACTUAL): April 1, 2009

Study Registration Dates

• First Submitted: January 22, 2009
• First Submitted That Met QC Criteria: January 23, 2009
• First Posted (ESTIMATE): January 26, 2009

Study Record Updates

• Last Update Posted (ACTUAL): September 12, 2019
• Last Update Submitted That Met QC Criteria: September 11, 2019
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: Abuse potential
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: APD356-013