Heroin Dependence
Conditions
Brief summary
A short-term treatment with buprenorphine prior to initiating treatment with naltrexone may increase the proportion of heroin-dependent patients successfully inducted onto Vivitrol.
Interventions
DRUGBuprenorphine/naloxone
3 week treatment with buprenorphine/naloxone
Sponsors
Alkermes, Inc.
New York State Psychiatric Institute
Study design
Allocation
NA
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. Individuals between the ages of 18-60 2. Meets DSM-5 criteria of current opioid use disorder with six consecutive months of reported heroin use, supported by a positive urine for opiates indicating regular use of heroin 3. Seeking treatment for opioid use disorder with Vivitrol 4. Capable of giving informed consent and complying with study procedures 5. In otherwise good health based on complete medical history and physical examination, laboratory tests, and EKG 6. BMI between 18-40
Exclusion criteria
1. Reported treatment with methadone in the last 3 months or positive urine toxicology for methadone on the day of consent 2. Maintenance on, or regular use of buprenorphine or other prescription opioids 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, cardiovascular disease. 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 neurocognitive disorder 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 11. Fentanyl only use, supported by a urine toxicology that is positive for fentanyl only and negative for all other opioids. 12. Court mandated to treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Heroin-dependent Patients Successfully Inducted Onto Vivitrol | 12 weeks | Number of patients who received the first Vivitrol injection among those who initiated the induction |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Short-term Treatment With Buprenorphine Short-term treatment with buprenorphine
Buprenorphine/naloxone: 3 week treatment with buprenorphine/naloxone followed by initiation of XR-naltrexone | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Short-term Treatment With Buprenorphine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age, Continuous | 44.5 years STANDARD_DEVIATION 10.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 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 | 1 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 | 1 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 1 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Proportion of Heroin-dependent Patients Successfully Inducted Onto Vivitrol
Number of patients who received the first Vivitrol injection among those who initiated the induction
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Short-term Treatment With Buprenorphine | Proportion of Heroin-dependent Patients Successfully Inducted Onto Vivitrol | 3 Participants |