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Buprenorphine as Adjunct to Outpatient Induction Onto Vivitrol

NCT03113409 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-03-02

Study results available
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Summary

The study will enroll 30 opioid-dependent participants into an open-label pilot outpatient study of methods to facilitate induction and stabilization onto XR-NTX. There will be three different methods of XR-NTX induction using increasing doses of oral naltrexone and buprenophine.

Conditions

  • Opioid-use Disorder

Interventions

DRUG

Buprenorphine

Buprenorphine will be administered daily

DRUG

Naltrexone

On study day 2, participants will receive increasing doses of oral naltrexone prior to administration of XR-NTX

DRUG

Vivitrol

Participants will receive one 380 i.m. injection on Study day 5 or 10, and another injection 4 weeks later.

Sponsors & Collaborators

  • New York State Psychiatric Institute

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-01
Primary Completion
2020-12-01
Completion
2020-12-01
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 NCT03113409 on ClinicalTrials.gov