Prescription Opiate/Medication Dependence
Conditions
Keywords
prescription opiates/medications, vivitrol, brain imaging
Brief summary
The proposed project will use fMRI and specific probes of reward and inhibition as biomarkers predicting drug use during and after treatment in 72 subjects addicted to prescription opioids/medications. Subjects will be scanned before, during, and after 12 weeks of active medication. The brain fMRI measures will be correlated with the primary clinical outcome of drug use (by urine drug screen) during the treatment and follow-up phase.
Interventions
DRUGVivitrol
There are monthly injections of depot naltrexone for 3 months.
Sponsors
University of Pennsylvania
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
No
Inclusion criteria
1. Sign an informed consent form; 2. Be between the ages of 18 and 60; 3. Have a diagnosis of opioid dependence according to DSM IV-TR criteria (as assessed by the MINI); 4. Be in good general health as determined by complete physical examination and laboratory tests; 5. Have a negative result for urinary opioids and must self report being at least 3 days opioid free. Participants may have a diagnosis of alcohol dependence so long as they do not have severe alcohol dependence that requires medical supervision for alcohol withdrawal.
Exclusion criteria
1. Current severe alcohol dependence that requires medical supervision for alcohol withdrawal; 2. Current psychosis, dementia, mental retardation, or history of schizophrenia; 3. Significant clinical abnormalities in hematology, chemistry, or urinalysis; 4. Significant clinical cardiovascular, neurological, hepatic, renal, pulmonary, metabolic, endocrine, or gastrointestinal disorders; 5. Female subjects who are pregnant or lactating, or female subjects of childbearing potential who are not using birth control (oral contraceptives, barrier (diaphragm or condom) plus spermicide, or levonorgestrel implant); (Pregnancy testing will be done on all females of child bearing age); and 6. Current diagnosis of chronic pain disorder.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Illicit-positive Urines During Treatment and Follow-up | three months |
Countries
United States
Participant flow
Pre-assignment details
50 individuals were lost to attrition. 4 individuals withdrew from the study.
Participants by arm
| Arm | Count |
|---|---|
| Naltrexone Intervention Eligible participants receive up to three monthly injections of 380 mg of naltrexone contained in dissolvable polymer microspheres and administered by deep intramuscular injection and slowly released over a period of approximately 4 weeks.
Vivitrol: There are monthly injections of depot naltrexone for 3 months. | 72 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 50 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Naltrexone Intervention |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 72 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 67 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized Race African American | 11 Participants |
| Race/Ethnicity, Customized Race Alaskan Native | 0 Participants |
| Race/Ethnicity, Customized Race American Indian | 0 Participants |
| Race/Ethnicity, Customized Race Asian/Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized Race Hispanic (Cuban) | 0 Participants |
| Race/Ethnicity, Customized Race Hispanic (Mexican) | 0 Participants |
| Race/Ethnicity, Customized Race Hispanic (Puerto Rican) | 3 Participants |
| Race/Ethnicity, Customized Race Other | 1 Participants |
| Race/Ethnicity, Customized Race White | 56 Participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 72 |
| other Total, other adverse events | 0 / 72 |
| serious Total, serious adverse events | 0 / 72 |
Outcome results
Primary
Illicit-positive Urines During Treatment and Follow-up
Time frame: three months
Population: Individuals were tested for presence of opioids: buprenorphine, methadone, opioids, and oxycontin within their urine toxicology
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Naltrexone Intervention | Illicit-positive Urines During Treatment and Follow-up | Injection One | Methadone | 0 Participants |
| Naltrexone Intervention | Illicit-positive Urines During Treatment and Follow-up | Injection One | Opioids | 1 Participants |
| Naltrexone Intervention | Illicit-positive Urines During Treatment and Follow-up | Injection One | Oxycontin | 1 Participants |
| Naltrexone Intervention | Illicit-positive Urines During Treatment and Follow-up | Injection One | Buprenorphine | 0 Participants |
| Naltrexone Intervention | Illicit-positive Urines During Treatment and Follow-up | Injection One | Negative Urine Test | 70 Participants |
| Naltrexone Intervention | Illicit-positive Urines During Treatment and Follow-up | Injection Two | Buprenorphine | 2 Participants |
| Naltrexone Intervention | Illicit-positive Urines During Treatment and Follow-up | Injection Two | Methadone | 0 Participants |
| Naltrexone Intervention | Illicit-positive Urines During Treatment and Follow-up | Injection Two | Opioids | 1 Participants |
| Naltrexone Intervention | Illicit-positive Urines During Treatment and Follow-up | Injection Two | Oxycontin | 2 Participants |
| Naltrexone Intervention | Illicit-positive Urines During Treatment and Follow-up | Injection Two | Negative Urine Test | 67 Participants |
| Naltrexone Intervention | Illicit-positive Urines During Treatment and Follow-up | Injection Three | Buprenorphine | 0 Participants |
| Naltrexone Intervention | Illicit-positive Urines During Treatment and Follow-up | Injection Three | Methadone | 0 Participants |
| Naltrexone Intervention | Illicit-positive Urines During Treatment and Follow-up | Injection Three | Opioids | 1 Participants |
| Naltrexone Intervention | Illicit-positive Urines During Treatment and Follow-up | Injection Three | Oxycontin | 0 Participants |
| Naltrexone Intervention | Illicit-positive Urines During Treatment and Follow-up | Injection Three | Negative Urine Test | 71 Participants |