Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: | Exclusion Criteria: |
Written, informed consent | Current or history of a major psychiatric illness, other than drug dependence or disorders secondary to drug abuse |
18 years of age or older | Meets DSM-IV criteria for dependence on any drugs other than cocaine, |
Current diagnosis of opioid dependence, based on Diagnostic and Statistical Manual of Mental Health Disorders, 4th Ed. (DSM-IV-TR) criteria | Physiologically dependent on alcohol and requires medical detoxification |
Voluntarily seeking treatment for opioid dependence | Use of prescription drugs within 14 days prior to study entry |
Completing or recently completed up to 30 days of inpatient treatment for opioid detoxification, and off all opioids (including buprenorphine and methadone) for at least 7 days | Use of non-prescription drugs within 7 days prior to study entry |
Noncustodial, stable residence and phone, plus 1 contact with verifiable address and phone | If female, used an oral contraceptive, Depo-Provera, Norplant, or intrauterine progesterone contraceptive system, within 30 days prior to study entry |
Significant other (eg, spouse, relative) willing to supervise compliance with the study visit schedule and procedures | Pregnant or breastfeeding |
able to provide written informed consent | History of liver disease and evidence of hepatic failure |
able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study | Active hepatitis and/or current elevated aspartate aminotransferase or alanine aminotransferase levels |
| Participated in any other clinical investigation within 4 weeks prior to study entry |
| History of any illness or behavior that, in the opinion of the investigator, might interfere with the study |
| Family history of early significant cardiovascular disease |
| Current major depression with suicidal ideation, psychosis, bipolar disorder, or any psychiatric disorder that would compromise the ability to complete the study |
| Dependence within prior year based on DSM-IV-TR, to any drugs other than prescription opioids or heroin, caffeine, marijuana, or nicotine |
| Active alcohol or stimulant dependence within prior 6 months |
| Current alcohol use disorder that would, in the Investigator’s opinion, preclude successful completion of the study |
| Positive urine drug test for cocaine, benzodiazepines, or amphetamines at the screening |
| Clinically significant medical condition or observed abnormalities (eg: physical exam, electrocardiogram (ECG), lab and/or urinalysis findings) |
| Known intolerance and/or hypersensitivity to naltrexone, nalmefene or polylactide-co-glycolide (PLG) |