Buprenorphine Stabilization and Induction Onto Vivitrol for Heroin-dependent Individuals
NCT ID: NCT03711318
Last Updated: 2022-12-22
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
8 participants
INTERVENTIONAL
2018-11-01
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Short-term treatment with buprenorphine
Short-term treatment with buprenorphine
Buprenorphine/naloxone
3 week treatment with buprenorphine/naloxone
Interventions
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Buprenorphine/naloxone
3 week treatment with buprenorphine/naloxone
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
60 Years
ALL
Yes
Sponsors
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Alkermes, Inc.
INDUSTRY
New York State Psychiatric Institute
OTHER
Responsible Party
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Adam Bisaga
Professor of Psychiatry
Locations
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New York State Psychiatric Institute
New York, New York, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Informed Consent Form
Document Type: Statistical Analysis Plan
Other Identifiers
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7699
Identifier Type: -
Identifier Source: org_study_id