Buprenorphine/Naloxone Stabilization and Induction Onto Injection Naltrexone

Completed · Phase 2/Phase 3

Conditions studied: Opioid Dependence

In brief

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.

Key facts

Study ID

NCT02294253

Run by

New York State Psychiatric Institute

People needed

30

Starts

2014-09-01

Expected to finish

2017-12-01

Last updated by the study team

2020-03-11

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 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 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.
• Painful medical condition that requires ongoing opioid analgesia or anticipated surgery necessitating opioid medications.

Where it is running

• STARS — New York, New York, United States

Full record on ClinicalTrials.gov

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