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NCT01882361
Opioid Relapse & HIV Risk: 48 Versus 24 Weeks of Injectable Extended Release Naltrexone
Phase 2/Phase 3 trial testing injectable naltrexone in Opiate Dependence in 77 participants. Completed in 31 July 2020.
31 July 2020
Quick facts
| Lead sponsor | University of Pennsylvania |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 77 |
| Start date | 1 June 2013 |
| Primary completion | 31 July 2020 |
| Estimated completion | 31 July 2020 |
| Sites | 1 location across Russia |
Drugs / interventions tested
- injectable naltrexone — full drug profile →
- placebo comparator
Conditions studied
- Opiate Dependence — all drugs for Opiate Dependence →
- Human Immunodeficiency Virus — all drugs for Human Immunodeficiency Virus →
Sponsor
University of Pennsylvania
Who can join
18 and older, any sex, with Opiate Dependence or Human Immunodeficiency Virus. 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.
-
Opiate positive urine tests
Time frame: 12 months
Reduction in drug use as seen by the primary urine outcomes will significantly favor the 48-week Vivitrol condition
Sponsor's own description
To address the question of the comparison of two courses of Vivitrol with differing lengths in 130 HIV negative, consenting, opioid addicted patients who have completed inpatient treatment. Participants will be randomized under double blind conditions to a 24 or 48-week course of pharmacotherapy, along with bi-weekly drug counselling, over 48 weeks, with follow-ups at weeks 60 and 72. The 24-week cohort will receive Vivitrol placebo injections in weeks 24 to 48.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01882361
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of injectable naltrexone
Trials testing the same drug.
- NCT04139213 — Medication Maintenance Therapy in Community Pharmacy Settings · Phase 2, PHASE3 · unknown
- NCT03766893 — Medication Maintenance Therapy in Community Pharmacy Settings · EARLY_PHASE1 · completed
Other University of Pennsylvania trials
Trials by the same sponsor.
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- 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)
- Trial protocol + status: ClinicalTrials.gov NCT01882361 (US National Library of Medicine, public domain)
- 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: 5 November 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/NCT01882361.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing