Opiate Dependence
Conditions
Keywords
opioid dependence, VIVITROL, opioid-related disorders
Brief summary
The purpose of this study is to determine the safety and tolerability of Medisorb® naltrexone (VIVITROL®) when administered over a period of 24 months to health care professionals who have a history of opioid dependence.
Interventions
Intramuscular (IM) injection administered once every 4 weeks for up to 2 years
Sponsors
Alkermes, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Primary Inclusion Criteria: * Health care professional (eg, physician, osteopath, nurse, pharmacist) * 18 years of age or older * Enrolled or enrolling in an extended outpatient treatment program for opioid dependence * Women of childbearing potential must agree to use an approved method of contraception for the duration of the study Primary
Exclusion criteria
* Pregnancy and/or lactation * Evidence of hepatic failure * Active hepatitis * Any psychiatric disorder that would compromise ability to complete study requirements * Recent history of suicidal ideation or attempt * Current dependence to any drugs other than prescription opioids or heroin, benzodiazepines, caffeine, marijuana, alcohol, or nicotine * Positive urine drug test or self-reported use of opioids, cocaine, or amphetamines at screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study. | 2 years (Baseline to end of study) | A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period). |
Countries
United States
Participant flow
Recruitment details
This study had a 12 month recruitment period (May 2009 through April 2010). A total of 11 sites in the United States participated. Principal Investigators were addiction specialists who had contact with health care professionals in need of treatment for opioid dependence.
Pre-assignment details
Potential subjects must have participated in a detoxification program for opioid dependence. Subjects participated in psychosocial treatment throughout their study participation.
Participants by arm
| Arm | Count |
|---|---|
| VIVITROL, 380mg | 38 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 7 |
| Overall Study | Lost to Follow-up | 7 |
| Overall Study | Other - False positive tests of the UDS | 1 |
| Overall Study | Other - Pregnancy | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Subject Relocated | 1 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | VIVITROL, 380mg |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 38 Participants |
| Age, Continuous | 42.4 years STANDARD_DEVIATION 10.39 |
| Region of Enrollment United States | 38 participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 37 / 38 |
| serious Total, serious adverse events | 2 / 38 |
Outcome results
Primary
Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study.
A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).
Time frame: 2 years (Baseline to end of study)
Population: The Safety Population, defined as all subjects who received at least 1 dose (injection) of study drug, was used for presentation and analysis of both safety and efficacy data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VIVITROL | Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study. | 37 participants |