Back to resultsBuprenorphine Stabilization and Induction Onto Vivitrol for Heroin-dependent Individuals
Primary Purpose
Heroin Dependence
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine/naloxone
Sponsored by
About this trial
This is an interventional treatment trial for Heroin Dependence
Eligibility Criteria
Inclusion Criteria:
- Individuals between the ages of 18-60
- Meets DSM-5 criteria of current opioid use disorder with six consecutive months of reported heroin use, supported by a positive urine for opiates indicating regular use of heroin
- Seeking treatment for opioid use disorder with Vivitrol
- Capable of giving informed consent and complying with study procedures
- In otherwise good health based on complete medical history and physical examination, laboratory tests, and EKG
- BMI between 18-40
Exclusion Criteria:
- Reported treatment with methadone in the last 3 months or positive urine toxicology for methadone on the day of consent
- Maintenance on, or regular use of buprenorphine or other prescription opioids
- 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, cardiovascular disease.
- 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 neurocognitive disorder
- 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
- Fentanyl only use, supported by a urine toxicology that is positive for fentanyl only and negative for all other opioids.
- Court mandated to treatment
Sites / Locations
- New York State Psychiatric Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Short-term treatment with buprenorphine
Arm Description
Short-term treatment with buprenorphine
Outcomes
Primary Outcome Measures
Proportion of Heroin-dependent Patients Successfully Inducted Onto Vivitrol
Number of patients who received the first Vivitrol injection among those who initiated the induction
Secondary Outcome Measures
Full Information
NCT ID
NCT03711318
First Posted
October 16, 2018
Last Updated
November 30, 2022
Sponsor
New York State Psychiatric Institute
Collaborators
Alkermes, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03711318
Brief Title
Buprenorphine Stabilization and Induction Onto Vivitrol for Heroin-dependent Individuals
Official Title
Buprenorphine Stabilization and Induction Onto Vivitrol for Heroin-dependent Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
continuing study was no longer feasible
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
Alkermes, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A short-term treatment with buprenorphine prior to initiating treatment with naltrexone may increase the proportion of heroin-dependent patients successfully inducted onto Vivitrol.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heroin Dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Short-term treatment with buprenorphine
Arm Type
Experimental
Arm Description
Short-term treatment with buprenorphine
Intervention Type
Drug
Intervention Name(s)
Buprenorphine/naloxone
Intervention Description
3 week treatment with buprenorphine/naloxone
Primary Outcome Measure Information:
Title
Proportion of Heroin-dependent Patients Successfully Inducted Onto Vivitrol
Description
Number of patients who received the first Vivitrol injection among those who initiated the induction
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Individuals between the ages of 18-60
Meets DSM-5 criteria of current opioid use disorder with six consecutive months of reported heroin use, supported by a positive urine for opiates indicating regular use of heroin
Seeking treatment for opioid use disorder with Vivitrol
Capable of giving informed consent and complying with study procedures
In otherwise good health based on complete medical history and physical examination, laboratory tests, and EKG
BMI between 18-40
Exclusion Criteria:
Reported treatment with methadone in the last 3 months or positive urine toxicology for methadone on the day of consent
Maintenance on, or regular use of buprenorphine or other prescription opioids
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, cardiovascular disease.
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 neurocognitive disorder
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
Fentanyl only use, supported by a urine toxicology that is positive for fentanyl only and negative for all other opioids.
Court mandated to treatment
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 Stabilization and Induction Onto Vivitrol for Heroin-dependent Individuals
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