Buprenorphine as Adjunct to Outpatient Induction Onto Vivitrol

Opioid-use Disorder Clinical Trial

Official title:

Buprenorphine as Adjunct to Outpatient Induction Onto Vivitrol

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03113409
• Other study ID #: #7456
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: June 1, 2017
• Est. completion date: December 1, 2020

Study information

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

Clinical Trial Summary

The study will enroll 30 opioid-dependent participants into an open-label pilot outpatient study of methods to facilitate induction and stabilization onto XR-NTX. There will be three different methods of XR-NTX induction using increasing doses of oral naltrexone and buprenophine.

Description:

Procedure 1: 5-day induction with increasing doses of oral naltrexone. Participants will receive XR-NTX on day five together with buprenorphine, and will continue receiving buprenorphine for 4 weeks until they receive 2nd XR-NTX dose.

Procedure 2: 10-day induction with buprenorphine administered daily and increasing daily doses of oral naltrexone beginning on day 2 . On day 10 participants will receive XR-NTX dose, and another one 4 weeks later. No buprenorphine will be given beyond day 10.

Procedure 3: 10-day induction with buprenorphine administered daily and increasing daily doses of oral naltrexone beginning on day 2 . On day 10 participants will receive XR-NTX dose, and another one 4 weeks later. Buprenorphine will continue for 4 weeks until the 2nd XR-NTX dose.

All participants will receive weekly therapy with a study psychiatrist. All participants will receive open-label medication.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Age 18-60.

2. Meets DSM-5 criteria for current opioid use disorder (moderate-severe) of at least six months duration, supported by urine toxicology OR COWS score > or =6 OR Naloxone Challenge.

3. Voluntarily seeking treatment for opioid dependence.

4. In otherwise good health based on complete medical history and physical examination within normal ranges (AST or ALT < 3 times normal). )

5. Able to give written informed consent.

Exclusion Criteria:

1. Methadone maintenance treatment or regular use of illicit methadone (> 30 mg per week).

2. Maintenance on, or regular use of buprenorphine or other long-acting narcotic agonists.

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.

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 organic mental disorder (e.g. AIDS (CD4 count under 200 currently or medically ill with an opportunistic infection) dementia).

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.

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder

Intervention

Drug:
• Buprenorphine
Buprenorphine will be administered daily
• Naltrexone
On study day 2, participants will receive increasing doses of oral naltrexone prior to administration of XR-NTX
• Vivitrol
Participants will receive one 380 i.m. injection on Study day 5 or 10, and another injection 4 weeks later.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients Who Receive the Second Injection of XR-NTX.	Percentage of patient who initiated Procedure 1 and completed the study receiving the 2nd injection of XR-NTX	4 weeks after 1st injection