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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02393599
Other study ID # Lorcaserin-Phase 1b-001
Secondary ID
Status Completed
Phase Phase 1
First received March 4, 2015
Last updated January 10, 2017
Start date May 2015
Est. completion date September 2015

Study information

Verified date October 2015
Source National Institute on Drug Abuse (NIDA)
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date September 2015
Est. primary completion date August 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Drug:
Lorcaserin
10 mg 2 times per day from Day 3 to 9 and one time on Day 10
Placebo
10 mg 2 times per day from Day 3 to 9 and one time on Day 10
Cocaine Infusion
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

Locations

Country Name City State
United States Vince Associates Clinical Research, Inc. Overland Park Kansas

Sponsors (1)

Lead Sponsor Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants with Adverse Events From intake (day -3) through follow-up (day 26) Yes
Primary Number of Participants with Cardiovascular Responses From screening (day -28 through day -4) through follow-up (day 26) Yes
Secondary 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 No
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