Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Buprenorphine as Adjunct to Outpatient Induction Onto Vivitrol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03113409
Recruitment Status : Recruiting
First Posted : April 13, 2017
Last Update Posted : May 27, 2019
Sponsor:
Information provided by (Responsible Party):
Adam Bisaga, New York State Psychiatric Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Opioid-use Disorder Drug: Buprenorphine Drug: Naltrexone Drug: Vivitrol Phase 2 Phase 3

Detailed 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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Buprenorphine as Adjunct to Outpatient Induction Onto Vivitrol
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Procedure 1
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.
Drug: Buprenorphine
Buprenorphine will be administered daily

Drug: Naltrexone
On study day 2, participants will receive increasing doses of oral naltrexone prior to administration of XR-NTX

Drug: Vivitrol
Participants will receive one 380 i.m. injection on Study day 5 or 10, and another injection 4 weeks later.
Other Name: XR-NTX

Experimental: Procedure 2
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.
Drug: Buprenorphine
Buprenorphine will be administered daily

Drug: Naltrexone
On study day 2, participants will receive increasing doses of oral naltrexone prior to administration of XR-NTX

Drug: Vivitrol
Participants will receive one 380 i.m. injection on Study day 5 or 10, and another injection 4 weeks later.
Other Name: XR-NTX

Experimental: Procedure 3
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.
Drug: Buprenorphine
Buprenorphine will be administered daily

Drug: Naltrexone
On study day 2, participants will receive increasing doses of oral naltrexone prior to administration of XR-NTX

Drug: Vivitrol
Participants will receive one 380 i.m. injection on Study day 5 or 10, and another injection 4 weeks later.
Other Name: XR-NTX




Primary Outcome Measures :
  1. Percentage of patients who receive the second injection of XR-NTX. [ Time Frame: 4 weeks after 1st injection ]
    Percentage of patient who initially received the 1st injection of XR-NTX, who receive the 2nd injection



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03113409


Contacts
Layout table for location contacts
Contact: Adam Bisaga, M.D. 646-774-6155 amb107@columbia.edu
Contact: Kaitlyn Mishlen, M.A. 646-774-6174 kaitlyn.mishlen@nyspi.columbia.edu

Locations
Layout table for location information
United States, New York
New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact: Kaitlyn Mishlen    646-774-6174      
Sponsors and Collaborators
New York State Psychiatric Institute

Layout table for additonal information
Responsible Party: Adam Bisaga, Research Psychiatrist, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT03113409     History of Changes
Other Study ID Numbers: #7456
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: May 27, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Adam Bisaga, New York State Psychiatric Institute:
Outpatient detoxification
Opioid dependence
Naltrexone
Vivitrol
Buprenorphine

Additional relevant MeSH terms:
Layout table for MeSH terms
Buprenorphine
Naltrexone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Alcohol Deterrents