search
Back to results

Study to Assess Potential Interactions Between Intravenous Cocaine and Oral Lorcaserin

Primary Purpose

Cocaine Abuse

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lorcaserin
Placebo
Cocaine Infusion
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cocaine Abuse

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Vince Associates Clinical Research, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lorcaserin

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of Participants with Adverse Events
Number of Participants with Cardiovascular Responses

Secondary Outcome Measures

Number of Participants with an Change in the Pharmacokinetics (PK) of Cocaine by Measuring the Cocaine Concentration in Plasma

Full Information

First Posted
March 4, 2015
Last Updated
January 10, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
search

1. Study Identification

Unique Protocol Identification Number
NCT02393599
Brief Title
Study to Assess Potential Interactions Between Intravenous Cocaine and Oral Lorcaserin
Official Title
Phase 1, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess Potential Interactions Between Intravenous Cocaine and Oral Lorcaserin
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Abuse

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lorcaserin
Arm Type
Experimental
Arm Description
Lorcaserin (10mg) will be administered 2 times per day from Days 3 to 9 and only one time on Day 10
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo will be administered 2 times per day from Days 3 to 9 and only one time on Day 10
Intervention Type
Drug
Intervention Name(s)
Lorcaserin
Intervention Description
10 mg 2 times per day from Day 3 to 9 and one time on Day 10
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
10 mg 2 times per day from Day 3 to 9 and one time on Day 10
Intervention Type
Drug
Intervention Name(s)
Cocaine Infusion
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events
Time Frame
From intake (day -3) through follow-up (day 26)
Title
Number of Participants with Cardiovascular Responses
Time Frame
From screening (day -28 through day -4) through follow-up (day 26)
Secondary Outcome Measure Information:
Title
Number of Participants with an Change in the Pharmacokinetics (PK) of Cocaine by Measuring the Cocaine Concentration in Plasma
Time Frame
Day 4, 6, 8 through 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debra Kelsh, Ph.D.
Organizational Affiliation
Vince & Associates Clinical Research, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vince Associates Clinical Research, Inc.
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study to Assess Potential Interactions Between Intravenous Cocaine and Oral Lorcaserin

We'll reach out to this number within 24 hrs