Buprenorphine/Naloxone Stabilization and Induction Onto Injection Naltrexone

NCT02294253 | Completed Phase 2 Results DMC

• 1 other identifier: 6999
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will randomize 50 opioid-dependent participants who have initially failed outpatient induction onto XR-NTX; participants will receive buprenorphine/naloxone on a weekly basis for 30 days. Buprenorphine/naloxone will be dispensed weekly during the 30-day stabilization and twice weekly during taper phase, and all patients who successfully complete the detoxification will be offered induction onto XR-NTX. All participants will receive weekly therapy with a study psychiatrist. All participants will receive open-label medication. The primary outcome of this study will be percentage of patients successfully inducted onto XR-NTX. Secondary outcomes will be time to relapse, defined as opioid use or dropout.

Conditions

Opioid Dependence

Outcome Measures

Primary Outcomes (1)

• Successful Induction Onto XR-NTX

  Proportion of participants inducted onto XR-NTX at the end of the 30-day buprenorphine/naloxone stabilization/taper.

  One week after completing 30-day buprenorphone/naloxone stabilization/taper.

Study Arms (1)

Buprenorphine/naloxone stabilization

EXPERIMENTAL

Participants who have initially failed outpatient induction onto XR-NTX will receive buprenorphine/naloxone (BUP) on a weekly basis that they will take daily,

Drug: Buprenorphine/naloxone

Interventions

Buprenorphine/naloxone DRUG

30 day oral Buprenorphine/naloxone

Also known as: Suboxone

Buprenorphine/naloxone stabilization

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-IV criteria for current opiate dependence disorder 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.
• Able to give written informed consent.
• Failed outpatient induction onto XR-NTX in Protocol #6374.

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 opioid agonists.
• ) 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, 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 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.
• \) Painful medical condition that requires ongoing opioid analgesia or anticipated surgery necessitating opioid medications.

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

STARS

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

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

adam.bisaga@nyspi.columbia.edu

646-774-6155

Study Officials

• Elizabeth Evans, M.D.

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Psychiatry

Study Record Dates

• First Submitted: November 17, 2014
• First Posted: November 19, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 11, 2020
• Results First Posted: March 11, 2020

Record last verified: 2020-03

Locations

US (1)