Buprenorphine as Adjunct to Outpatient Induction Onto Vivitrol

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: Opioid-use Disorder
• Intervention / Treatment: Drug: Buprenorphine; Drug: Naltrexone; Drug: Vivitrol

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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.	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

• Sponsor: New York State Psychiatric Institute

Study record dates

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: Naltrexone; Vivitrol; Buprenorphine; Opioid dependence; Outpatient detoxification
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Alcohol Deterrents; Buprenorphine; Naltrexone
• 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