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NCT03143543
Phase I Functional Magnetic Resonance Imaging (fMRI) Pharmacodynamic Studies of Compounds for Opioid Use Disorder and Cocaine Use Disorder
Phase 1 trial testing Group A Lorcaserin (10mg) in Cocaine-Related Disorders in 171 participants. Terminated before completion.
6 December 2019
Quick facts
| Lead sponsor | Virginia Commonwealth University |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 171 |
| Start date | 1 July 2015 |
| Primary completion | 6 December 2019 |
| Estimated completion | 6 December 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Group A Lorcaserin (10mg) — full drug profile →
- Group A2 Lorcaserin (20 mg) — full drug profile →
- Group B Parallel Placebo
- Group B2 Parallel Placebo
Conditions studied
- Cocaine-Related Disorders — all drugs for Cocaine-Related Disorders →
- Opioid-Related Disorders — all drugs for Opioid-Related Disorders →
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.
-
Target engagement by lorcaserin
Time frame: Seven Days
To determine target engagement by lorcaserin in a cocaine-Stroop and/or opioid-Stroop cue-reactivity fMRI task in cocaine use disorder (CocUD) and/or Opioid Use Disorder Subjects
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):
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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 -
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 -
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
Verify or expand the search:
- PubMed search for NCT03143543
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03143543 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Virginia Commonwealth University
- Last refreshed: 23 April 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03143543.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing