Status:
COMPLETED
Nalrexone Facilitated Discontinuation of Buprenorphine
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Stable Opioid Dependence
Eligibility:
All Genders
18-49 years
Phase:
PHASE1
PHASE2
Brief Summary
The efficacy of buprenorphine as a long-term agonist treatment has been offset by the emergence of intolerable withdrawal phenomena in a subset of individuals on chronic maintenance who attempt to dis...
Eligibility Criteria
Inclusion
- Adult, aged 18-49.
- Currently maintained on buprenorphine, with a clinically acceptable interest in tapering or discontinuing it
- Willingness to switch over to naltrexone
- In otherwise good health based on complete medical history, physical examination, vital signs measurement, ECG, and laboratory tests (hematology, blood chemistry, urinalysis) within normal ranges.
- Able to give informed consent and comply with study procedures,
- Currently on 2 mg or less of buprenorphine.
- Voluntarily seeking treatment for opioid dependence.
Exclusion
- Significant current suicidal risk or 1 or more suicide attempts within the past year
- History of accidental drug overdose in the last three years defined as an episode of opioid-induced unconsciousness or incapacitation, whether or not medical treatment was sought or received.
- Positive serum pregnancy test, lactation, or unwillingness to use a satisfactory method of birth control
- Active psychiatric disorder which might interfere with participation or make participation hazardous, including DSM-IV organic mental disorder, psychotic disorder, or bipolar disorder with mania
- History of allergic reaction, adverse reaction, or sensitivity to any study medication.
- Acute hepatitis with SGOT or SGPT \> 3 times the upper end of the laboratory normal range (chronic hepatitis is acceptable as we have found naltrexone treatment well tolerate and safe among patients with chronic hepatitis)
- Currently prescribed or regularly taking opioids for chronic pain
- Current participation in another intensive psychotherapy or substance abuse treatment program, or participation in another treatment study.
- Opioid dependence is not well-managed, and characterized by relapses, slips, or missed doses
- Concurrent treatment with psychotropic medications which may interact adversely with naltrexone, such as duloxetine and valproic acid.
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01895036
Start Date
February 1 2011
End Date
September 1 2013
Last Update
June 15 2018
Active Locations (1)
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1
NYSPI
New York, New York, United States, 10032