Clinical trial NCT03711318: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Heroin Dependence
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: Alkermes, Inc.
First posted: 2018-10-18
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Heroin-dependent Patients Successfully Inducted Onto Vivitrol
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
References: