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NCT03143543

Phase I Functional Magnetic Resonance Imaging (fMRI) Pharmacodynamic Studies of Compounds for Opioid Use Disorder and Cocaine Use Disorder

Terminated Phase 1 Last updated 23 April 2020
What this trial tests

Phase 1 trial testing Group A Lorcaserin (10mg) in Cocaine-Related Disorders in 171 participants. Terminated before completion.

Timeline
1 July 2015
Primary endpoint
6 December 2019
6 December 2019

Quick facts

Lead sponsorVirginia Commonwealth University
PhasePhase 1
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment171
Start date1 July 2015
Primary completion6 December 2019
Estimated completion6 December 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Virginia Commonwealth University

Who can join

Adults 18 to 55, any sex, with Cocaine-Related Disorders or Opioid-Related Disorders. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

The purpose of Project 2 is to execute phase I functional magnetic resonance imaging (fMRI) studies to assess the effects of lorcaserin on brain target engagement (measured by fMRI brain activation and neural connectivity) in cocaine use disorder (CocUD) subjects and/or opioid use disorder.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The behavioral pharmacology and therapeutic potential of lorcaserin for substance use disorders.
    Collins GT, Gerak LR, France CP. · · 2018 · cited 27× · PMID 29246856 · DOI 10.1016/j.neuropharm.2017.12.023
  2. Converging vulnerability factors for compulsive food and drug use.
    Serafine KM, O'Dell LE, Zorrilla EP. · · 2021 · cited 17× · PMID 33862029 · DOI 10.1016/j.neuropharm.2021.108556
  3. Improving Translational Research Outcomes for Opioid Use Disorder Treatments.
    Jones JD, Varshneya NB, Hudzik TJ, Huhn AS. · · 2021 · cited 10× · PMID 37377692 · DOI 10.1007/s40429-020-00353-5

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