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

NCT03143543 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 171

Last updated 2020-04-27

No results posted yet for this study

Summary

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.

Conditions

  • Cocaine-Related Disorders
  • Opioid-Related Disorders

Interventions

DRUG

Group A Lorcaserin (10mg)

10 mg lorcaserin orally for 7 days

DRUG

Group A2 Lorcaserin (20 mg)

20 mg lorcaserin orally for 7 days

OTHER

Group B Parallel Placebo

Oral placebo vs 10 mg lorcaserin

OTHER

Group B2 Parallel Placebo

Oral placebo vs 20 mg lorcaserin

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • James Bjork, PhD · Virginia Commonwealth University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2019-12-06
Completion
2019-12-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03143543 on ClinicalTrials.gov