Who is sponsoring NCT01587196?

NCT01587196 is sponsored by University of Pennsylvania.

What drugs are being tested in NCT01587196?

Interventions in NCT01587196: Vivitrol.

What condition does NCT01587196 study?

NCT01587196 studies Prescription Opiate/Medication Dependence.

Is NCT01587196 still recruiting?

NCT01587196 is currently completed. Last updated 9 October 2024.

Are results published for NCT01587196?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-10-09 · How we verify

NCT01587196: fMRI CURE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

CURE Addiction Center of Excellence: Brain Mechanisms of Relapse and Recovery - Prescription Opiates/Medication

Completed Phase 2 Results posted Last updated 9 October 2024

What this trial tests

Phase 2 trial testing Vivitrol in Prescription Opiate/Medication Dependence in 72 participants. Completed in 1 January 2021.

Timeline

1 January 2012

Primary endpoint
1 January 2021

1 January 2021

Quick facts

Lead sponsor	University of Pennsylvania
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	72
Start date	1 January 2012
Primary completion	1 January 2021
Estimated completion	1 January 2021
Sites	1 location across United States

Drugs / interventions tested

Vivitrol — full drug profile →

Conditions studied

Prescription Opiate/Medication Dependence — all drugs for Prescription Opiate/Medication Dependence →

Sponsor

University of Pennsylvania

Who can join

Adults 18 to 60, any sex, with Prescription Opiate/Medication Dependence. 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.

Illicit-positive Urines During Treatment and Follow-up
Time frame: three months

Sponsor's own description

The proposed project will use fMRI and specific probes of reward and inhibition as biomarkers predicting drug use during and after treatment in 72 subjects addicted to prescription opioids/medications. Subjects will be scanned before, during, and after 12 weeks of active medication. The brain fMRI measures will be correlated with the primary clinical outcome of drug use (by urine drug screen) during the treatment and follow-up phase.

Publications & conference data

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

Reduced cigarette smoking during injectable extended-release naltrexone treatment for opioid use disorder.
Wang AL, Shi Z, Elman I, Langleben DD. · · 2020 · cited 7× · PMID 32379516 · DOI 10.1080/00952990.2020.1741001
Brain network segregation is associated with drug use severity in individuals with opioid use disorder.
Hager NM, Wang X, Ramos-Rolón AP, Childress AR, et al · · 2025 · cited 2× · PMID 40945409 · DOI 10.1016/j.drugalcdep.2025.112863

Verify or expand the search:

Other trials of Vivitrol

Trials testing the same drug.

NCT04454411 — Brain Mechanisms of Pharmacotherapy in Opioid Use Disorder · Phase 2 · terminated
NCT04828694 — Pharmacokinetic and Safety Study of Naltrexone Release From Subcutaneous BICX104 Pellets Compared to Vivitrol Injections · Phase 1 · completed
NCT03232346 — A Strategy to Improve Success of Treatment Discontinuation in Buprenorphine Responders · Phase 3 · completed
NCT03113409 — Buprenorphine as Adjunct to Outpatient Induction Onto Vivitrol · Phase 2, PHASE3 · terminated

Other University of Pennsylvania trials

Trials by the same sponsor.

NCT06081153 — Mechanistic Clinical Trial of PCSK9 Inhibition for AAA · EARLY_PHASE1 · not yet recruiting
NCT07415772 — Effect of cTBS on Startle and TMS-evoked BOLD · NA · not yet recruiting
NCT07489430 — DaxibotulinumtoxinA for Blepharospasm · Phase 2 · not yet recruiting
NCT07463131 — Negative Income Tax Trial · NA · not yet recruiting
NCT06645769 — Na-Phenylbutyrate VAscular Trial · EARLY_PHASE1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01587196 (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 University of Pennsylvania
Last refreshed: 9 October 2024

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/NCT01587196.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing