Study to Assess Potential Interactions Between Intravenous Cocaine and Oral Lorcaserin

NCT ID: NCT02393599

Last Updated: 2017-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2015-09-30

Brief 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).

Conditions

Cocaine Abuse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

Lorcaserin

Lorcaserin (10mg) will be administered 2 times per day from Days 3 to 9 and only one time on Day 10

Group Type: EXPERIMENTAL

Lorcaserin

Intervention Type: DRUG

10 mg 2 times per day from Day 3 to 9 and one time on Day 10

Cocaine Infusion

Intervention Type: DRUG

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

Placebo

Placebo will be administered 2 times per day from Days 3 to 9 and only one time on Day 10

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

10 mg 2 times per day from Day 3 to 9 and one time on Day 10

Interventions

Lorcaserin

10 mg 2 times per day from Day 3 to 9 and one time on Day 10

Intervention Type: DRUG

Placebo

10 mg 2 times per day from Day 3 to 9 and one time on Day 10

Intervention Type: DRUG

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Debra Kelsh, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Vince & Associates Clinical Research, Inc.

Locations

Vince Associates Clinical Research, Inc.

Overland Park, Kansas, United States

Countries

United States

Other Identifiers

Lorcaserin-Phase 1b-001

Identifier Type: -

Identifier Source: org_study_id