Status:
COMPLETED
Buprenorphine/Naloxone Stabilization and Induction Onto Injection Naltrexone
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Opioid Dependence
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
PHASE3
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 ...
Detailed Description
Buprenorphine induction/stabilization/taper: Buprenorphine induction will be conducted at our STARS clinic and according to current clinical guidelines. Participants who have initially failed outpatie...
Eligibility Criteria
Inclusion
- Age 18-60.
- 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.
- Voluntarily seeking treatment for opioid dependence.
- In otherwise good health based on complete medical history and physical examination.
- Able to give written informed consent.
- Failed outpatient induction onto XR-NTX in Protocol #6374.
Exclusion
- Methadone maintenance treatment or regular use of illicit methadone (\> 30 mg per week).
- Maintenance on, or regular use of, buprenorphine or other long-acting opioid agonists.
- ) 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.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02294253
Start Date
September 1 2014
End Date
December 1 2017
Last Update
March 11 2020
Active Locations (1)
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1
STARS
New York, New York, United States, 10032