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Trial record 1 of 1 for:    NCT02537873
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Drug Interaction and Self Administration Studies of Compounds for Cocaine Use Disorder

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Virginia Commonwealth University
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT02537873
First received: August 25, 2015
Last updated: June 6, 2017
Last verified: June 2017
  Purpose
The overall goal of this project is to develop initial human data on effects of novel compounds on safety (interactions with cocaine) and efficacy (subjective response to cocaine and self administration data) in non-treatment seeking cocaine use disorder subjects. The compound to be studied will be the 5-HT2CR agonist lorcaserin. Lorcaserin and other 5-HT2CR agonists have been shown to reduce cocaine self-administration and cue reactivity in rodents. In addition there is human safety data in non-cocaine using subjects for lorcaserin as it is currently FDA approved for obesity, and safety data from a cocaine interaction study in rodents , but there is no human cocaine interaction/PK data and no PD data to support potential dosages for phase II clinical trials.

Condition Intervention Phase
Cocaine Use Disorder Drug: Lorcaserin Drug: Cocaine Intravenous (IV) Drug: Placebo comparator Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Basic Science
Official Title: Phase I Drug Interaction and Self Administration Studies of Compounds for Cocaine Use Disorder

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 4 days (Study days 1, 2, 6, 12) ]
    Heart rate (HR) and blood pressure (BP) measures during saline infusions will be compared to HR and BP after each cocaine infusion (20 mg and 40 mg doses). Changes in HR and BP induced by cocaine infusion along with lorcaserin will be compared to those without lorcaserin, by cocaine dose level (20 mg and 40 mg doses), using repeated measures analysis of variance (ANOVA). Changes in ECG readings during saline infusion as compared to those taken during cocaine infusions will be reported as summary statistics. Adverse event data will be compiled for lorcaserin and placebo cohorts and presented as summary statistics.

  • Cocaine Self-administration Choice Selection [ Time Frame: 3 days (Study days 3, 9, 13) ]
    Repeated measures ANOVA (Analysis of Variance) with cocaine dose (0mg, 25mg) and lorcaserin dose (0mg, 10mg, 20mg) as within subject factors will be used to examine differences in mean cocaine choice selection. In addition, a Bayesian analysis will be carried out.

  • Subjective response to cocaine measured by Visual Analog Scale [ Time Frame: 4 days (Study days 1, 2, 6, 12) ]
    Subjective response measures (VAS or Visual Analog Scale) obtained during saline infusions will be compared between lorcaserin and placebo subjects to those during cocaine infusions by cocaine dose level (10, 20, 40 mg) to determine the extent to which these measures are modified by the administration of lorcaserin using repeated measures ANOVA.

  • Cocaine PK with Placebo [ Time Frame: 1 day (Study day 2) ]
    Plasma concentration-time profiles of cocaine after cocaine infusion during placebo administration (Day 2) will be analyzed to obtain pharmacokinetic parameter estimates of cocaine (Tmax, AUC, apparent t½, CL) by individual. These parameters will be compared within subjects on sessions with lorcaserin (Days 6 and 12).

  • Cocaine PK with Lorcaserin [ Time Frame: 2 days (Study days 6, 12) ]
    Plasma concentration-time profiles of cocaine after cocaine infusion during placebo administration (Day 2) will be analyzed to obtain pharmacokinetic parameter estimates of cocaine (Tmax, AUC, apparent t½, CL) by individual. These parameters will be compared within subjects on sessions with lorcaserin (Days 6 and 12).


Secondary Outcome Measures:
  • Response inhibition during Immediate Memory Task (IMT) [ Time Frame: 3 days (Study days 1, 8, 11) ]
    Commission errors on the IMT (Immediate Memory Task) will be compared between lorcaserin and placebo subjects to determine the extent to which this measure is modified by the administration of lorcaserin using repeated measures ANOVA.


Estimated Enrollment: 18
Study Start Date: July 2015
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: Lorcaserin and Cocaine IV

Lorcaserin 10 mg administered orally once daily for 6 days then increasing to twice daily for 3 days.

Cocaine IV (intravenous) administered in ascending doses of 0, 10, 20, 40 mg on study days 1, 2, 6 and 12.

Drug: Lorcaserin
Lorcaserin HCL 10mg tablets (Belviq, Arena Pharmaceuticals)
Other Name: Belviq
Drug: Cocaine Intravenous (IV)
Cocaine IV administered at doses of 10, 20 and 40 mg during 4 dosing sessions
Placebo Comparator: Arm 2: Placebo Comparator and Cocaine IV
Dextrose placebo in gelatin capsule identical to experimental drug. Cocaine IV (intravenous) administered in ascending doses of 0, 10, 20, 40 mg on study days 1, 2, 6 and 12.
Drug: Cocaine Intravenous (IV)
Cocaine IV administered at doses of 10, 20 and 40 mg during 4 dosing sessions
Drug: Placebo comparator
Dextrose in gelatin capsule

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

In order to participate in this study, subjects must:

  1. Males and females between 18 and 59 years-of-age.
  2. Understand the study procedures and provide written informed consent.
  3. Meet current DSM-5 criteria for cocaine use disorder, at least moderate severity, and current DSM-IV diagnosis of cocaine dependence, but are not seeking treatment.
  4. Currently using cocaine by smoking or intravenous route of administration as determined by self-report and have a positive urine drug screen for cocaine during screening.
  5. Have vital signs as follows: resting pulse below 95 bpm, blood pressures below 140 mm Hg systolic and 90 mm Hg diastolic.
  6. Have no clinically significant abnormalities in the judgment of the study physician in hematology and chemistry laboratory tests including liver function tests.
  7. Have sinus rhythm with normal conduction (including QTcF less than 440 ms) by ECG.
  8. Have no contraindications for study participation as determined by medical history and physical examination.
  9. Be able to demonstrate an understanding of study procedures and follow instructions including behavioral laboratory testing.
  10. No pregnant or nursing women will be permitted in the study, and women must either be unable to conceive (i.e., surgically sterilized, sterile, or postmenopausal) or be using a reliable form of contraception (e.g., abstinence, birth control pills, intrauterine device with spermicide, or condoms). Men will be advised to use condoms. All females must provide negative pregnancy urine tests before study entry, at each visit during the study, and at the end of study participation.
  11. Have hemoglobin/hematocrit values within normal limits based on age and gender.

In order to participate in the study, subjects must not:

  1. Meet current DSM-5 diagnosis of any psychoactive substance use disorder other than cocaine, opiates, marijuana, or nicotine. Diagnosis of mild to moderate use disorder for alcohol will not be considered exclusionary.
  2. Have a DSM-5 axis I psychiatric disorder other than substance use disorder including but not limited to Bipolar Disorder, Major Depressive Disorder, ADHD, or Schizophrenia or a neurological disorder requiring ongoing treatment and/or making study participation unsafe.
  3. Have any previous medically adverse reaction to cocaine, including loss of consciousness, chest pain, or epileptic seizure.
  4. Have any clinically significant medical disorder including cardiovascular (including hypertension), pulmonary, CNS, hepatic, or renal disorder.
  5. Have a history of seizures (excluding childhood febrile seizures), or loss of consciousness for more than 20 minutes.
  6. Have significant current suicidal or homicidal ideation or a history of suicide attempt within the past 6 months.
  7. Have conditions of probation or parole requiring reports of drug use to officers of the court.
  8. Have impending incarceration.
  9. Have a positive HIV test by self-report or history.
  10. Be pregnant or nursing or not using a reliable form of contraception if able to conceive. All females must provide negative pregnancy urine tests at screening, and daily after hospital admission.
  11. Have any other illness, or condition, which in the opinion of the PI would preclude safe and/or successful completion of the study.
  12. Have a positive breath alcohol test or urine drug screening positive for drugs of abuse with the exception of cocaine, opiates, cocaine metabolites, and marijuana.
  13. Have a score greater than 5 on the Clinical Opiates Withdrawal Scale (COWS) on any screening, monitoring or hospital study visit.
  14. Subjects who are allergic to lorcaserin.
  15. Subjects who have taken any investigational drug within 90 days prior to baseline.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02537873

Contacts
Contact: Sade Johns, PhD 804-828-3210 sejohns@vcu.edu

Locations
United States, Virginia
Virginia Commonwealth University, Institute for Drug and Alcohol Studies Recruiting
Richmond, Virginia, United States, 23219
Contact: Sade Johns, PhD    804-828-3210    sejohns@vcu.edu   
Principal Investigator: Frederick G Moeller, MD         
Sponsors and Collaborators
Virginia Commonwealth University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Frederick G Moeller, MD Virginia Commonwealth University
  More Information

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT02537873     History of Changes
Other Study ID Numbers: HM20003768
1U54DA038999 ( US NIH Grant/Contract Award Number )
Study First Received: August 25, 2015
Last Updated: June 6, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Virginia Commonwealth University:
Cocaine Use Disorder

Additional relevant MeSH terms:
Disease
Substance-Related Disorders
Pathologic Processes
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

ClinicalTrials.gov processed this record on June 23, 2017