Buprenorphine as Adjunct to Outpatient Induction Onto Vivitrol

NCT03113409 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: #7456
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid-use Disorder

Keywords

Outpatient detoxification; Opioid dependence; Naltrexone; Vivitrol; Buprenorphine

Outcome Measures

Primary Outcomes (1)

• 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

  4 weeks after 1st injection

Study Arms (3)

Procedure 1

EXPERIMENTAL

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; Drug: Naltrexone; Drug: Vivitrol

Procedure 2

EXPERIMENTAL

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; Drug: Naltrexone; Drug: Vivitrol

Procedure 3

EXPERIMENTAL

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; Drug: Naltrexone; Drug: Vivitrol

Interventions

Buprenorphine DRUG

Buprenorphine will be administered daily

Procedure 1; Procedure 2; Procedure 3

Naltrexone DRUG

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

Procedure 1; Procedure 2; Procedure 3

Vivitrol DRUG

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

Also known as: XR-NTX

Procedure 1; Procedure 2; Procedure 3

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine; Naltrexone; vivitrol

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Naloxone

Results Point of Contact

• Title: Adam Bisaga MD
• Organization: NYS Psychiatric Institute

adam.bisaga@nyspi.columbia.edu

646-774-6155

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Psychiatrist

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: April 13, 2017
• Study Start: June 1, 2017
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 2, 2022
• Results First Posted: March 2, 2022

Record last verified: 2022-02

Locations

US (1)