NCT02680288

Brief Summary

This is a randomized, cross-over, single-blind, placebo-controlled, single-center, multiple-panel evaluation of the potential for oral lorcaserin to modify cocaine self-administration in a laboratory setting. To prevent unauthorized drug use, study medications will be administered as participants are confined during overnight stays at the Medical Center. Non-treatment-seeking, regular cocaine users will receive oral treatment with single doses of placebo, lorcaserin 10 mg (Panel 1), or lorcaserin 20 mg (Panel 2). Afterwards, the subjective and reinforcing effects of intravenous cocaine will be measured in a laboratory setting.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2015

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 11, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

March 18, 2016

Status Verified

March 1, 2016

Enrollment Period

2.8 years

First QC Date

February 5, 2016

Last Update Submit

March 16, 2016

Conditions

Cocaine Use Disorders

Keywords

Psychostimulant, Craving, Cocaine.

Outcome Measures

Primary Outcomes (1)

  • Cocaine-Induced 'High'

    Visual analogue scale rating of 'high' after receiving cocaine

    Day 1 of Lorcaserin Treatment

Secondary Outcomes (1)

  • Cocaine-Induced Craving

    Day 1 of Lorcaserin treatment.

Study Arms (3)

Oral Placebo

PLACEBO COMPARATOR

Oral inert treatment

Other: Oral Placebo

Active Treatment, Low-Dose

EXPERIMENTAL

Lorcaserin 10 mg, single dose

Drug: Lorcaserin, 10 mg

Active Treatment, High-Dose

EXPERIMENTAL

Lorcaserin 20 mg, single dose

Drug: Lorcaserin, 20 mg

Interventions

Lorcaserin, 10 mgDRUG

Oral type 2C serotonergic agonist, low-dose

Also known as: Belviq
Active Treatment, Low-Dose
Lorcaserin, 20 mgDRUG

Oral type 2C serotonergic agonist, high-dose

Also known as: Belviq
Active Treatment, High-Dose
Oral PlaceboOTHER

Oral inert treatment

Oral Placebo

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Is non-treatment-seeking and has used cocaine regularly for at least six months.
  • Has used cocaine by a rapid route of administration (smoked or intravenous injection), at least three times per week, for three of the preceding six weeks.
  • Is male or female, between 21 and 50 years old.
  • Is able to verbalize understanding of the consent form, able to provide written informed consent, and verbalize willingness to complete study procedures.
  • Is agreeable to the study schedule and likely to complete all interventions and measures.
  • Has a medical history, physical exam, and screening laboratory results that demonstrate no contraindication to participation.

You may not qualify if:

  • Has a history of a medical adverse reaction to cocaine or other psycho stimulants, including loss of consciousness, chest pain, cardiac ischemia, or seizure.
  • Has any current Axis I psychiatric disorder other than drug abuse or dependence.
  • Meets DSM-IV-TR criteria for dependence on opiates, benzodiazepines, alcohol, or other sedative-hypnotics.
  • Has received opiate-substitution therapy within two months prior to enrollment.
  • Has a current or past history of seizure disorder other than febrile seizures, including alcohol- or psycho stimulant- related seizures, or family history of seizure disorder.
  • Has a diagnosis of adult asthma or chronic obstructive pulmonary disease.
  • Has had head trauma that resulted in neurological sequelae (e.g., loss of memory for greater than 5 minutes).
  • Has a history of valvular heart disease, congestive heart failure, syncope, bradycardia, or any other cardiac condition.
  • Has a condition that increases the risk of cocaine-induced hypertension or ischemic heart disease, such as hypertension, hypercholesterolemia, renal disease (serum creatinine \> 1.4 mg/dl), diabetes (fasting glucose level ≥ 100 mg/dl).
  • Has a history of jaundice, hepatitis, or laboratory evidence of hepatic insufficiency (total bilirubin ≥ 2.0, serum albumin ≤ 3.5 gm./dl); or current abnormalities of liver function testing with serologic evidence of hepatitis (serology and coagulation will be evaluated in individuals with aspartate transaminase or Alaine aminotransferase \> 40 IU/L).
  • History of priapism or conditions that would predispose to priapism (sickle cell anemia, multiple myeloma, leukemia, Peyronie's disease, or other anatomical deformation of the penis).
  • Currently being treated for erectile dysfunction.
  • Has an unstable medical condition, which, in the judgment of investigators, would make participation hazardous, such as AIDS or active TB.
  • If female, is pregnant or lactating (nursing), not practicing adequate methods of contraception, or planning to become pregnant within one month of conclusion of the study.
  • Has current suicidal ideation as assessed by the SCID interview.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kansas City VA Medical Center

Kansas City, Missouri, 64128, United States

RECRUITING

Related Publications (3)

  • Burmeister JJ, Lungren EM, Kirschner KF, Neisewander JL. Differential roles of 5-HT receptor subtypes in cue and cocaine reinstatement of cocaine-seeking behavior in rats. Neuropsychopharmacology. 2004 Apr;29(4):660-8. doi: 10.1038/sj.npp.1300346.

    PMID: 14627998BACKGROUND

  • Cunningham KA, Fox RG, Anastasio NC, Bubar MJ, Stutz SJ, Moeller FG, Gilbertson SR, Rosenzweig-Lipson S. Selective serotonin 5-HT(2C) receptor activation suppresses the reinforcing efficacy of cocaine and sucrose but differentially affects the incentive-salience value of cocaine- vs. sucrose-associated cues. Neuropharmacology. 2011 Sep;61(3):513-23. doi: 10.1016/j.neuropharm.2011.04.034. Epub 2011 May 11.

    PMID: 21575646BACKGROUND

  • Pirtle JL, Hickman MD, Boinpelly VC, Surineni K, Thakur HK, Grasing KW. The serotonin-2C agonist Lorcaserin delays intravenous choice and modifies the subjective and cardiovascular effects of cocaine: A randomized, controlled human laboratory study. Pharmacol Biochem Behav. 2019 May;180:52-59. doi: 10.1016/j.pbb.2019.02.010. Epub 2019 Feb 24.

    PMID: 30811963DERIVED

MeSH Terms

Interventions

lorcaserin

Study Officials

  • Kenneth W Grasing, MD

    Midwest Biomedical Research Foundation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Midwest Biomedical Research Foundation KCVA

CONTACT

(816) 499-1614Kenneth.Grasing@va.gov

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician

Study Record Dates

First Submitted

February 5, 2016

First Posted

February 11, 2016

Study Start

November 1, 2015

Primary Completion

September 1, 2018

Study Completion

November 1, 2019

Last Updated

March 18, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)