Study to Assess Potential Interactions Between Intravenous Cocaine and Oral Lorcaserin
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 1/12/2017 |
| Start Date: | May 2015 |
| End Date: | September 2015 |
Phase 1, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess Potential Interactions Between Intravenous Cocaine and Oral Lorcaserin
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).
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).
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:
1. diaphragm and condom by partner
2. condom and spermicide by partner
3. intrauterine device and condom by partner
4. sponge and condom by partner
5. complete abstinence from sexual intercourse
6. 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
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