Buprenorphine as Adjunct to Outpatient Induction Onto Vivitrol
Opioid-use Disorder
About this trial
This is an interventional treatment trial for Opioid-use Disorder focused on measuring Outpatient detoxification, Opioid dependence, Naltrexone, Vivitrol, Buprenorphine
Eligibility Criteria
Inclusion Criteria:
- Age 18-60.
- 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.
- Voluntarily seeking treatment for opioid dependence.
- In otherwise good health based on complete medical history and physical examination within normal ranges (AST or ALT < 3 times normal). )
- Able to give written informed consent.
Exclusion Criteria:
- Methadone maintenance treatment or regular use of illicit methadone (> 30 mg per week).
- Maintenance on, or regular use of buprenorphine or other long-acting narcotic agonists.
- Pregnancy, lactation, or failure in a sexually active woman to use adequate contraceptive methods.
- 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.
- 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.
- Physiologically dependent on alcohol or sedative- hypnotics with impending withdrawal. Other substance use diagnoses are not exclusionary.
- History of allergic or adverse reaction to buprenorphine, naltrexone, naloxone, clonidine, or clonazepam.
- Chronic organic mental disorder (e.g. AIDS (CD4 count under 200 currently or medically ill with an opportunistic infection) dementia).
- 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.
- Painful medical condition that requires ongoing opioid analgesia or anticipated surgery necessitating opioid medications.
Sites / Locations
- New York State Psychiatric Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Procedure 1
Procedure 2
Procedure 3
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.