Study to Assess Potential Interactions Between Intravenous Cocaine and Oral Lorcaserin

Study Overview
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Brief Summary
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The primary objective of this study is to determine if there are significant interactions between oral lorcaserin treatment concurrent with 20 and 40 mg intravenous (i.v.) cocaine infusions by measuring adverse events (AEs) and cardiovascular responses including heart rate (HR), blood pressure (BP), and electrocardiogram (ECG) (including QTc).

Official Title
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Phase 1, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess Potential Interactions Between Intravenous Cocaine and Oral Lorcaserin

Conditions
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Cocaine Abuse

Intervention / Treatment
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* Drug: Lorcaserin
* Drug: Placebo
* Drug: Cocaine Infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be volunteers who are not seeking treatment for drug addiction. Be between 18 and 50 years-of-age. Meet Diagnostic and Statistical Manual (DSM-IV) - Text Revision (TR) criteria for current cocaine abuse as assessed using the MINI neuropsychiatric interview (version 6.0). Have a body mass index (BMI) within a range of 18.0 to 34.0 kg/m2 and a minimum weight of at least 50.0 kg at screening. Have experience using cocaine by the smoked or i.v. route at least 6 times in the past 12 months prior to clinic intake (Day -3) and at least one use within the past 30 days. Provide a urine sample positive for cocaine at least once during screening (Days -28 to -4). Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures. Females must have a negative serum pregnancy test at screening and negative urine pregnancy test at intake prior to receiving the first dose of investigational drug. They must also be postmenopausal, have had a hysterectomy, been sterilized, have a partner with a vasectomy, or agree to use one of the following methods of birth control starting at least 14 days prior to clinic intake: diaphragm and condom by partner condom and spermicide by partner intrauterine device and condom by partner sponge and condom by partner complete abstinence from sexual intercourse oral contraceptives, Depo-Provera, Norplant, Patch, and intrauterine progesterone contraceptive Be able to comply with protocol requirements, rules and regulations of the study site and be likely to complete all the study treatments. Exclusion Criteria: Please contact site directly for more information

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lorcaserin<br>Lorcaserin (10mg) will be administered 2 times per day from Days 3 to 9 and only one time on Day 10 | Drug: Lorcaserin<br>* 10 mg 2 times per day from Day 3 to 9 and one time on Day 10<br>Drug: Cocaine Infusion<br>* Screening / Session 1, Study Day -2: 20 mg cocaine, followed by a saline infusion, followed by 40 mg cocaine Baseline/ Session 2, Study Day 1: Saline or 20 mg cocaine followed by either 20 mg cocaine or saline Baseline / Session 3, Study Day 2: Saline or 40 mg cocaine followed by either 40 mg cocaine or saline Treatment / Session 4, Study Day 9: Saline or 20 mg cocaine followed by either 20 mg cocaine or saline Treatment / Session 5, Study Day10: Saline or 40 mg cocaine followed by either 40 mg cocaine or saline<br>|
| Placebo Comparator: Placebo<br>Placebo will be administered 2 times per day from Days 3 to 9 and only one time on Day 10 | Drug: Placebo<br>* 10 mg 2 times per day from Day 3 to 9 and one time on Day 10<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events |  | From intake (day -3) through follow-up (day 26) | 
| Number of Participants with Cardiovascular Responses |  | From screening (day -28 through day -4) through follow-up (day 26) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with an Change in the Pharmacokinetics (PK) of Cocaine by Measuring the Cocaine Concentration in Plasma |  | Day 4, 6, 8 through 12 |