Buprenorphine as Adjunct to Outpatient Induction Onto Vivitrol

February 4, 2022 updated by: Adam Bisaga, New York State Psychiatric Institute
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Procedure 1: 5-day induction with increasing doses of oral naltrexone. Participants will receive XR-NTX on day five together with buprenorphine, and will continue receiving buprenorphine for 4 weeks until they receive 2nd XR-NTX dose.

Procedure 2: 10-day induction with buprenorphine administered daily and increasing daily doses of oral naltrexone beginning on day 2 . On day 10 participants will receive XR-NTX dose, and another one 4 weeks later. No buprenorphine will be given beyond day 10.

Procedure 3: 10-day induction with buprenorphine administered daily and increasing daily doses of oral naltrexone beginning on day 2 . On day 10 participants will receive XR-NTX dose, and another one 4 weeks later. Buprenorphine will continue for 4 weeks until the 2nd XR-NTX dose.

All participants will receive weekly therapy with a study psychiatrist. All participants will receive open-label medication.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • New York State Psychiatric Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18-60.
  2. Meets DSM-5 criteria for current opioid use disorder (moderate-severe) of at least six months duration, supported by urine toxicology OR COWS score > or =6 OR Naloxone Challenge.
  3. Voluntarily seeking treatment for opioid dependence.
  4. In otherwise good health based on complete medical history and physical examination within normal ranges (AST or ALT < 3 times normal). )
  5. Able to give written informed consent.

Exclusion Criteria:

  1. Methadone maintenance treatment or regular use of illicit methadone (> 30 mg per week).
  2. Maintenance on, or regular use of buprenorphine or other long-acting narcotic agonists.
  3. Pregnancy, lactation, or failure in a sexually active woman to use adequate contraceptive methods.
  4. Active medical illness which might make participation hazardous, such as untreated hypertension, acute hepatitis with AST or ALT > 3 times normal, AIDS (CD4 count under 200 currently or medically ill with an opportunistic infection), unstable diabetes.
  5. Active psychiatric disorder which might interfere with participation or make participation hazardous, including DSM-5 Schizophrenia or any psychotic disorder, severe Major Depressive Disorder, or suicide risk or 1 or more suicide attempts within the past year.
  6. Physiologically dependent on alcohol or sedative- hypnotics with impending withdrawal. Other substance use diagnoses are not exclusionary.
  7. History of allergic or adverse reaction to buprenorphine, naltrexone, naloxone, clonidine, or clonazepam.
  8. Chronic organic mental disorder (e.g. AIDS (CD4 count under 200 currently or medically ill with an opportunistic infection) dementia).
  9. History of accidental drug overdose in the last 3 years as defined as an episode of opioid-induced unconsciousness or incapacitation, whether or not medical treatment was sought or received.
  10. Painful medical condition that requires ongoing opioid analgesia or anticipated surgery necessitating opioid medications.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Procedure 1
Procedure 1: 5-day induction with increasing doses of oral naltrexone. Participants will receive XR-NTX on day five together with buprenorphine, and will continue receiving buprenorphine for 4 weeks until they receive 2nd XR-NTX dose.
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.
Other Names:
  • XR-NTX
Experimental: Procedure 2
Procedure 2: 10-day induction with buprenorphine administered daily and increasing daily doses of oral naltrexone beginning on day 2 . On day 10 participants will receive XR-NTX dose, and another one 4 weeks later. No buprenorphine will be given beyond day 10.
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.
Other Names:
  • XR-NTX
Experimental: Procedure 3
Procedure 3: 10-day induction with buprenorphine administered daily and increasing daily doses of oral naltrexone beginning on day 2 . On day 10 participants will receive XR-NTX dose, and another one 4 weeks later. Buprenorphine will continue for 4 weeks until the 2nd XR-NTX dose.
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.
Other Names:
  • XR-NTX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients Who Receive the Second Injection of XR-NTX.
Time Frame: 4 weeks after 1st injection
Percentage of patient who initiated Procedure 1 and completed the study receiving the 2nd injection of XR-NTX
4 weeks after 1st injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

April 10, 2017

First Submitted That Met QC Criteria

April 10, 2017

First Posted (Actual)

April 13, 2017

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 4, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #7456

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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