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Buprenorphine/Naloxone Stabilization and Induction Onto Injection Naltrexone

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. Read our disclaimer for details. Identifier: NCT02294253
Recruitment Status : Completed
First Posted : November 19, 2014
Results First Posted : March 11, 2020
Last Update Posted : March 11, 2020
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Adam Bisaga, New York State Psychiatric Institute

Brief Summary:
The investigators will randomize 50 opioid-dependent participants who have initially failed outpatient induction onto XR-NTX; participants will receive buprenorphine/naloxone on a weekly basis for 30 days. Buprenorphine/naloxone will be dispensed weekly during the 30-day stabilization and twice weekly during taper phase, and all patients who successfully complete the detoxification will be offered induction onto XR-NTX. All participants will receive weekly therapy with a study psychiatrist. All participants will receive open-label medication. The primary outcome of this study will be percentage of patients successfully inducted onto XR-NTX. Secondary outcomes will be time to relapse, defined as opioid use or dropout.

Condition or disease Intervention/treatment Phase
Opioid Dependence Drug: Buprenorphine/naloxone Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Buprenorphine/Naloxone Stabilization and Induction Onto Injection Naltrexone: An Outpatient Detoxification for Opioid Dependence.
Actual Study Start Date : September 2014
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Buprenorphine/naloxone stabilization
Participants who have initially failed outpatient induction onto XR-NTX will receive buprenorphine/naloxone (BUP) on a weekly basis that they will take daily,
Drug: Buprenorphine/naloxone
30 day oral Buprenorphine/naloxone
Other Name: Suboxone

Primary Outcome Measures :
  1. Successful Induction Onto XR-NTX [ Time Frame: One week after completing 30-day buprenorphone/naloxone stabilization/taper. ]
    Proportion of participants inducted onto XR-NTX at the end of the 30-day buprenorphine/naloxone stabilization/taper.

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.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Age 18-60.
  2. Meets DSM-IV criteria for current opiate dependence disorder 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.
  5. Able to give written informed consent.
  6. Failed outpatient induction onto XR-NTX in Protocol #6374.

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 opioid 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, 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 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 identifier (NCT number): NCT02294253

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United States, New York
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
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Principal Investigator: Elizabeth Evans, M.D. Columbia University
  Study Documents (Full-Text)

Documents provided by Adam Bisaga, New York State Psychiatric Institute:
Study Protocol  [PDF] August 13, 2018
Statistical Analysis Plan  [PDF] August 13, 2018

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Responsible Party: Adam Bisaga, Professor in Psychiatry, New York State Psychiatric Institute Identifier: NCT02294253    
Other Study ID Numbers: 6999
First Posted: November 19, 2014    Key Record Dates
Results First Posted: March 11, 2020
Last Update Posted: March 11, 2020
Last Verified: March 2020
Additional relevant MeSH terms:
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Buprenorphine, Naloxone Drug Combination
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists