Phase 3
N=30
Buprenorphine/Naloxone Stabilization and Induction Onto Injection Naltrexone
Opioid Dependence
Bottom Line
View on ClinicalTrials.gov: NCT02294253 ↗Enrolled (actual)
30
Serious AEs
3.3%
Results posted
Mar 2020
Primary outcome: Primary: Successful Induction Onto XR-NTX — 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Buprenorphine/naloxone (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Successful Induction Onto XR-NTX |
8 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 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 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT02294253). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.