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OpenTrials
Completed

NCT Number: NCT02393599

Study to Assess Potential Interactions Between Intravenous Cocaine and Oral Lorcaserin

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).

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Key information

Conditions

Cocaine Abuse Chemically-Induced Disorders Cocaine-Related Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Vince Associates Clinical Research, Inc.

Overland Park, Kansas, 66212, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lorcaserin

Drug

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

Placebo

Drug

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

Cocaine Infusion

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 19, 2015
Registry last updated
Jan 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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