Buprenorphine Stabilization and Induction Onto Vivitrol for Heroin-dependent Individuals

Heroin Dependence Clinical Trial

Official title:

Buprenorphine Stabilization and Induction Onto Vivitrol for Heroin-dependent Individuals

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03711318
• Other study ID #: 7699
• Status: Terminated
• Phase: Phase 3
• Start date: November 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2022
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Heroin Dependence

Intervention

Drug:
• Buprenorphine/naloxone
3 week treatment with buprenorphine/naloxone

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	Alkermes, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Heroin-dependent Patients Successfully Inducted Onto Vivitrol	Number of patients who received the first Vivitrol injection among those who initiated the induction	12 weeks