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Buprenorphine Stabilization and Induction Onto Vivitrol for Heroin-dependent Individuals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03711318
Recruitment Status : Recruiting
First Posted : October 18, 2018
Last Update Posted : December 17, 2018
Alkermes, Inc.
Information provided by (Responsible Party):
Adam Bisaga, New York State Psychiatric Institute

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.

Condition or disease Intervention/treatment Phase
Heroin Dependence Drug: Buprenorphine/naloxone Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Buprenorphine Stabilization and Induction Onto Vivitrol for Heroin-dependent Individuals
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heroin

Arm Intervention/treatment
Experimental: Short-term treatment with buprenorphine
Short-term treatment with buprenorphine
Drug: Buprenorphine/naloxone
3 week treatment with buprenorphine/naloxone

Primary Outcome Measures :
  1. Proportion of heroin-dependent patients successfully inducted onto Vivitrol [ Time Frame: 12 weeks ]
    Number of patients who were successfully inducted onto Vivitrol

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 18 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Individuals between the ages of 18-60
  2. 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
  3. Seeking treatment for opioid use disorder with Vivitrol
  4. Capable of giving informed consent and complying with study procedures
  5. In otherwise good health based on complete medical history and physical examination, laboratory tests, and EKG
  6. BMI between 18-40

Exclusion Criteria:

  1. Reported treatment with methadone in the last 3 months or positive urine toxicology for methadone on the day of consent
  2. Maintenance on, or regular use of buprenorphine or other prescription opioids
  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, cardiovascular disease.
  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 neurocognitive disorder
  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
  11. Fentanyl only use, supported by a urine toxicology that is positive for fentanyl only and negative for all other opioids.
  12. Court mandated to treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03711318

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Contact: Kaitlyn Mishlen, M.A. 646-774-6174

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United States, New York
New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact: Kaitlyn D Mishlen, M.A.    646-774-6174   
Sponsors and Collaborators
New York State Psychiatric Institute
Alkermes, Inc.

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Responsible Party: Adam Bisaga, Professor of Psychiatry, New York State Psychiatric Institute Identifier: NCT03711318     History of Changes
Other Study ID Numbers: 7699
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Buprenorphine, Naloxone Drug Combination
Heroin Dependence
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists