Opioid-use Disorder
Conditions
Keywords
Outpatient detoxification, Opioid dependence, Naltrexone, Vivitrol, Buprenorphine
Brief summary
The study will enroll 30 opioid-dependent participants into an open-label pilot outpatient study of methods to facilitate induction and stabilization onto XR-NTX. There will be three different methods of XR-NTX induction using increasing doses of oral naltrexone and buprenophine.
Detailed description
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. All participants will receive weekly therapy with a study psychiatrist. All participants will receive open-label medication.
Interventions
DRUGBuprenorphine
Buprenorphine will be administered daily
DRUGNaltrexone
On study day 2, participants will receive increasing doses of oral naltrexone prior to administration of XR-NTX
DRUGVivitrol
Participants will receive one 380 i.m. injection on Study day 5 or 10, and another injection 4 weeks later.
Sponsors
New York State Psychiatric Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 18-60. 2. 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. 3. Voluntarily seeking treatment for opioid dependence. 4. In otherwise good health based on complete medical history and physical examination within normal ranges (AST or ALT \< 3 times normal). ) 5. Able to give written informed consent.
Exclusion criteria
1. Methadone maintenance treatment or regular use of illicit methadone (\> 30 mg per week). 2. Maintenance on, or regular use of buprenorphine or other long-acting narcotic 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 (CD4 count under 200 currently or medically ill with an opportunistic infection), 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 (CD4 count under 200 currently or medically ill with an opportunistic infection) 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Who Receive the Second Injection of XR-NTX. | 4 weeks after 1st injection | Percentage of patient who initiated Procedure 1 and completed the study receiving the 2nd injection of XR-NTX |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Procedure 1 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.
Buprenorphine: Buprenorphine will be administered daily
Naltrexone: On study day 2, participants will receive increasing doses of oral naltrexone prior to administration of XR-NTX
Vivitrol: Participants will receive one 380 i.m. injection on Study day 5 or 10, and another injection 4 weeks later. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 5 | 0 | 0 |
Baseline characteristics
| Characteristic | Procedure 1 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Age, Continuous | 34.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Percentage of Patients Who Receive the Second Injection of XR-NTX.
Percentage of patient who initiated Procedure 1 and completed the study receiving the 2nd injection of XR-NTX
Time frame: 4 weeks after 1st injection
Population: all participants enrolled in the study (Procedure 1)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Procedure 1 | Percentage of Patients Who Receive the Second Injection of XR-NTX. | 6 Participants |