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Study to Assess Potential Interactions Between Intravenous Cocaine and Oral Lorcaserin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02393599
Recruitment Status : Completed
First Posted : March 19, 2015
Last Update Posted : January 11, 2017
Sponsor:
Information provided by (Responsible Party):
National Institute on Drug Abuse (NIDA)

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).

Condition or disease Intervention/treatment Phase
Cocaine Abuse Drug: Lorcaserin Drug: Placebo Drug: Cocaine Infusion Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Official Title: Phase 1, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess Potential Interactions Between Intravenous Cocaine and Oral Lorcaserin
Study Start Date : May 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : September 2015

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Arm Intervention/treatment
Experimental: Lorcaserin
Lorcaserin (10mg) will be administered 2 times per day from Days 3 to 9 and only one time on Day 10
Drug: Lorcaserin
10 mg 2 times per day from Day 3 to 9 and one time on Day 10

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

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




Primary Outcome Measures :
  1. Number of Participants with Adverse Events [ Time Frame: From intake (day -3) through follow-up (day 26) ]
  2. Number of Participants with Cardiovascular Responses [ Time Frame: From screening (day -28 through day -4) through follow-up (day 26) ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02393599


Locations
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United States, Kansas
Vince Associates Clinical Research, Inc.
Overland Park, Kansas, United States, 66212
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Debra Kelsh, Ph.D. Vince & Associates Clinical Research, Inc.
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Responsible Party: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT02393599    
Other Study ID Numbers: Lorcaserin-Phase 1b-001
First Posted: March 19, 2015    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: October 2015
Additional relevant MeSH terms:
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Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Cocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents