Alcoholism, Opiate Dependence
Conditions
Brief summary
This was a multicenter extension of Alkermes' Study ALK21-006 (NCT01218997) designed to assess the long-term safety of repeat monthly doses of naltrexone long-acting injection. All subjects received open-label Medisorb® naltrexone 380 mg (VIVITROL®). Planned treatment duration was up to 3 years. Alkermes terminated the study for business purposes in December 2006. The median duration of treatment among all subjects in this extension study was 43 weeks.
Detailed description
From the date of successful completion of Study ALK21-006 (base study \[NCT01218997\])), all subjects, including those who received oral naltrexone during the base study, were given the option to enroll in this extension study. Study investigators ensured that subjects were opioid-free and did not demonstrate evidence of withdrawal prior to administration of VIVITROL therapy. If the investigator suspected recent clinically significant opioid use, a naloxone challenge test was performed. The naloxone challenge was not performed in a subject presenting clinical signs or symptoms of opioid withdrawal or in a subject whose urine contained opioids.
Interventions
Administered via intramuscular (IM) injection once every 4 weeks. Subjects in this dosing group also received this treatment throughout the base study.
DRUGOral naltrexone to Medisorb naltrexone 380 mg
Subjects in this dosing group received oral naltrexone 50 mg in the base study, but received only Medisorb naltrexone 380 mg in this extension study, administered via IM injection once every 4 weeks.
Sponsors
Alkermes, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Primary Inclusion Criteria: * Adults with a diagnosis of alcohol and/or opioid dependence as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) who had satisfactorily completed Alkermes' Study ALK21-006 or other qualifying Medisorb naltrexone study * Willing and able to return for scheduled clinic visits and study assessments * Had a stable address * Agreed to use a contraception for the duration of the study and for 1 month following the last dose if of childbearing potential * Written informed consent Primary
Exclusion criteria
* Pregnancy or lactation * Terminated early from study drug in a previous Medisorb naltrexone clinical trial * Any finding that, in the view of the investigator, would compromise the ability to fulfill the protocol visit schedule and/or visit requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Who Reported at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study. | Up to 3 years | 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). |
Participant flow
Recruitment details
Recruitment was conducted at 17 clinical trial study centers in the United States.
Pre-assignment details
Investigators ensured subjects were opioid-free (ie, had opioid-free urine screening results) prior to initiation of study therapy. For subjects diagnosed with opioid dependence or in whom clinically significant opioid use was suspected, a naloxone challenge test was performed.
Participants by arm
| Arm | Count |
|---|---|
| Medisorb Naltrexone 380 mg (VIVITROL) Subjects in this dosing group received VIVITROL (Medisorb naltrexone 380 mg) via intramuscular (IM) injection once every 4 weeks throughout the base study and continued on the same regimen throughout this extension. | 92 |
| Oral Naltrexone to Medisorb Naltrexone 380 mg (VIVITROL) Subjects in this dosing group switched from oral naltrexone 50 mg daily in the base study to receive VIVITROL (Medisorb naltrexone 380) mg via IM injection once every 4 weeks in this extension study. | 16 |
| Total | 108 |
Baseline characteristics
| Characteristic | Oral Naltrexone to Medisorb Naltrexone 380 mg (VIVITROL) | Medisorb Naltrexone 380 mg (VIVITROL) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 92 Participants | 108 Participants |
| Age Continuous | 45.3 years STANDARD_DEVIATION 11.5 | 42.3 years STANDARD_DEVIATION 10 | 42.7 years STANDARD_DEVIATION 10.3 |
| Region of Enrollment United States | 16 participants | 92 participants | 108 participants |
| Sex: Female, Male Female | 5 Participants | 30 Participants | 35 Participants |
| Sex: Female, Male Male | 11 Participants | 62 Participants | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 62 / 92 | 11 / 16 |
| serious Total, serious adverse events | 9 / 92 | 2 / 16 |
Outcome results
Primary
Number of Subjects Who Reported 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: Up to 3 years
Population: Safety population includes all enrolled subjects who received at least 1 dose of study drug (VIVITROL 380 mg) in this extension study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medisorb Naltrexone 380 mg (VIVITROL) | Number of Subjects Who Reported at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study. | 62 Participants |
| Oral Naltrexone to Medisorb Naltrexone 380 mg (VIVITROL) | Number of Subjects Who Reported at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study. | 11 Participants |