Abuse Potential of Single Doses of Lorcaserin in Healthy Recreational Polydrug Users - Full Text View

Sponsored by:	Arena Pharmaceuticals
Information provided by:	Arena Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00828659

Purpose

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

Condition	Intervention	Phase
Drug Abuse Healthy	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	Phase I

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Pharmacodynamics Study
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

Further study details as provided by Arena Pharmaceuticals:

Primary Outcome Measures:

To evaluate the abuse potential of lorcaserin [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate the safety and tolerability of lorcaserin [ Designated as safety issue: Yes ]

Estimated Enrollment:	35
Study Start Date:	December 2008
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

INCLUSION CRITERIA

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.

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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00828659

Locations

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

Sponsors and Collaborators

Arena Pharmaceuticals

More Information

No publications provided

Responsible Party:	Arena Pharmaceuticals, Inc. ( Christen Anderson, MD, PhD )
Study ID Numbers:	APD356-013
Study First Received:	January 22, 2009
Last Updated:	July 27, 2009
ClinicalTrials.gov Identifier:	NCT00828659 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Arena Pharmaceuticals:

Abuse potential

Study placed in the following topic categories:

Mental Disorders
Substance-Related Disorders
Disorders of Environmental Origin
Healthy

Additional relevant MeSH terms:

Mental Disorders
Substance-Related Disorders
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on September 10, 2009