Study to Assess Potential Interactions Between Intravenous Cocaine and Oral Lorcaserin

Cocaine Abuse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02393599
• Other study ID #: Lorcaserin-Phase 1b-001
• 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

• Cocaine Abuse
• Cocaine-Related Disorders

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