Buprenorphine Stabilization and Induction Onto Vivitrol for Heroin-dependent Individuals

• Sponsor: New York State Psychiatric Institute (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03711318
• Collaborator: Alkermes, Inc. (Industry)
• Enrollment: 8
• Location: 1
• Arm: 1
• Actual Duration (Months): 38
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Heroin Dependence	Drug: Buprenorphine/naloxone	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: N/A
• 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: Nov 1, 2018
• Actual Primary Completion Date: Dec 31, 2021
• Actual Study Completion Date: Dec 31, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Proportion of heroin-dependent patients successfully inducted onto Vivitrol [12 weeks]

   Number of patients who were successfully inducted onto Vivitrol

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 18 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York State Psychiatric Institute	New York	New York	United States	10032

Sponsors and Collaborators

• New York State Psychiatric Institute
• Alkermes, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Adam Bisaga, Professor of Psychiatry, New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT03711318
• Other Study ID Numbers: 7699
• First Posted: Oct 18, 2018
• Last Update Posted: Feb 22, 2022
• Last Verified: Feb 1, 2022

• 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
• Additional relevant MeSH terms: Heroin Dependence; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone

Study Results

No Results Posted as of Feb 22, 2022