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Buprenorphine as Adjunct to Outpatient Induction Onto Vivitrol

Primary Purpose

Opioid-use Disorder

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Buprenorphine

Naltrexone

Vivitrol

About this trial

This is an interventional treatment trial for Opioid-use Disorder focused on measuring Outpatient detoxification, Opioid dependence, Naltrexone, Vivitrol, Buprenorphine

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Age 18-60.
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.
Voluntarily seeking treatment for opioid dependence.
In otherwise good health based on complete medical history and physical examination within normal ranges (AST or ALT < 3 times normal). )
Able to give written informed consent.

Exclusion Criteria:

Methadone maintenance treatment or regular use of illicit methadone (> 30 mg per week).
Maintenance on, or regular use of buprenorphine or other long-acting narcotic agonists.
Pregnancy, lactation, or failure in a sexually active woman to use adequate contraceptive methods.
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.
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.
Physiologically dependent on alcohol or sedative- hypnotics with impending withdrawal. Other substance use diagnoses are not exclusionary.
History of allergic or adverse reaction to buprenorphine, naltrexone, naloxone, clonidine, or clonazepam.
Chronic organic mental disorder (e.g. AIDS (CD4 count under 200 currently or medically ill with an opportunistic infection) dementia).
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.
Painful medical condition that requires ongoing opioid analgesia or anticipated surgery necessitating opioid medications.

Sites / Locations

New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Procedure 1

Procedure 2

Procedure 3

Arm Description

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.

Outcomes

Primary Outcome Measures

Percentage of Patients Who Receive the Second Injection of XR-NTX.

Percentage of patient who initiated Procedure 1 and completed the study receiving the 2nd injection of XR-NTX

Secondary Outcome Measures

Full Information

NCT ID

NCT03113409

First Posted

April 10, 2017

Last Updated

February 4, 2022

Sponsor

New York State Psychiatric Institute

1. Study Identification

Unique Protocol Identification Number

NCT03113409

Brief Title

Buprenorphine as Adjunct to Outpatient Induction Onto Vivitrol

Official Title

Buprenorphine as Adjunct to Outpatient Induction Onto Vivitrol

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Terminated

Why Stopped

no funding available to continue

Study Start Date

June 1, 2017 (Actual)

Primary Completion Date

December 1, 2020 (Actual)

Study Completion Date

December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

New York State Psychiatric Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Opioid-use Disorder

Keywords

Outpatient detoxification, Opioid dependence, Naltrexone, Vivitrol, Buprenorphine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Procedure 1

Arm Type

Experimental

Arm Description

Arm Title

Procedure 2

Arm Type

Experimental

Arm Description

Arm Title

Procedure 3

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Buprenorphine

Intervention Description

Buprenorphine will be administered daily

Intervention Type

Drug

Intervention Name(s)

Naltrexone

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Vivitrol

Other Intervention Name(s)

XR-NTX

Intervention Description

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

Primary Outcome Measure Information:

Title

Percentage of Patients Who Receive the Second Injection of XR-NTX.

Description

Percentage of patient who initiated Procedure 1 and completed the study receiving the 2nd injection of XR-NTX

Time Frame

4 weeks after 1st injection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18-60. 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. Voluntarily seeking treatment for opioid dependence. In otherwise good health based on complete medical history and physical examination within normal ranges (AST or ALT < 3 times normal). ) Able to give written informed consent. Exclusion Criteria: Methadone maintenance treatment or regular use of illicit methadone (> 30 mg per week). Maintenance on, or regular use of buprenorphine or other long-acting narcotic agonists. Pregnancy, lactation, or failure in a sexually active woman to use adequate contraceptive methods. 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. 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. Physiologically dependent on alcohol or sedative- hypnotics with impending withdrawal. Other substance use diagnoses are not exclusionary. History of allergic or adverse reaction to buprenorphine, naltrexone, naloxone, clonidine, or clonazepam. Chronic organic mental disorder (e.g. AIDS (CD4 count under 200 currently or medically ill with an opportunistic infection) dementia). 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. Painful medical condition that requires ongoing opioid analgesia or anticipated surgery necessitating opioid medications.

Facility Information:

Facility Name

New York State Psychiatric Institute

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

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Buprenorphine as Adjunct to Outpatient Induction Onto Vivitrol

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