Clinical trial NCT02393599: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cocaine Abuse
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2015-03-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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).


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

Primary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: From intake (day -3) through follow-up (day 26)
measure: Number of Participants with Cardiovascular Responses
timeFrame: From screening (day -28 through day -4) through follow-up (day 26)
Secondary outcomes:
measure: Number of Participants with an Change in the Pharmacokinetics (PK) of Cocaine by Measuring the Cocaine Concentration in Plasma
timeFrame: Day 4, 6, 8 through 12
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Vince Associates Clinical Research, Inc.
state: Kansas
Study officials:
affiliation: Vince & Associates Clinical Research, Inc.
name: Debra Kelsh, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: