Alcohol Dependence
Conditions
Keywords
Alcohol Dependence
Brief summary
This was a Phase 3 multicenter extension of Alkermes' Study ALK21-003 (NCT01218958 \[the base study\]) that evaluated the safety of Medisorb® naltrexone (VIVITROL®) administered every 4 weeks for 48 weeks (13 injections) in alcohol-dependent adults who had completed Study ALK21-003.
Detailed description
All participants in this study received Medisorb naltrexone at double-blinded dose strengths (ie, 190 mg or 380 mg); no participant received placebo. Participants who had received Medisorb naltrexone in Study ALK21-003 (NCT01218958) continued to receive the same dose strength in this extension study. Those who had received placebo for Medisorb naltrexone 190 mg in the base study were given Medisorb naltrexone 190 mg. Participants who had received placebo for Medisorb naltrexone 380 mg in the base study were given Medisorb naltrexone 380 mg. Neither the identity or dose of the treatment received in the base study, nor the Medisorb naltrexone dose strength (190 mg or 380 mg) received in this extension were revealed to any participant, the investigator, or any blinded member of the clinical study team during the conduct of the base study or this extension. All participants were encouraged to receive standardized biopsychosocial support at each clinic visit throughout the study; however, unlike the base study, participation was not mandatory. Participants eligible for this extension study had received all 6 injections of study drug in the base study; those who received Medisorb naltrexone in the base study who also received all 13 injections in this extension therefore had a duration of exposure of approximately 76 weeks (\ 1.5 years) upon completion of this extension. For participants who had received placebo in the base study, maximum duration of exposure was approx. 48 weeks (1 year).
Interventions
naltrexone for extended-release injectable suspension
naltrexone for extended-release injectable suspension
Sponsors
Alkermes, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Primary Inclusion Criteria: * Completed study drug treatment in Study ALK21-003 (base study \[NCT01218958\]) * Written informed consent for this extension study * Stable address and telephone; reconfirmation of contact's address and phone * Women with childbearing potential must agree to continue to use an approved method of birth control throughout study participation Primary
Exclusion criteria
* Positive urine drug screen for opioids at Visit 1 * Early termination of study drug in the base study * Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While in Study | Up to 48 weeks (13 injections), not including base study | A TEAE is any adverse event, 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
Participants by arm
| Arm | Count |
|---|---|
| Medisorb Naltrexone 380 mg | 175 |
| Medisorb Naltrexone 190 mg | 157 |
| Total | 332 |
Baseline characteristics
| Characteristic | Medisorb Naltrexone 190 mg | Medisorb Naltrexone 380 mg | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 7 Participants | 15 Participants |
| Age, Categorical Between 18 and 65 years | 149 Participants | 168 Participants | 317 Participants |
| Age Continuous | 47.4 years STANDARD_DEVIATION 10.5 | 45.5 years STANDARD_DEVIATION 9.6 | 46.4 years STANDARD_DEVIATION 10 |
| Region of Enrollment United States | 157 participants | 175 participants | 332 participants |
| Sex: Female, Male Female | 53 Participants | 62 Participants | 115 Participants |
| Sex: Female, Male Male | 104 Participants | 113 Participants | 217 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 143 / 175 | 130 / 157 | 51 / 60 | 92 / 115 | 46 / 55 | 84 / 102 |
| serious Total, serious adverse events | 6 / 175 | 12 / 157 | 2 / 60 | 4 / 115 | 2 / 55 | 10 / 102 |
Outcome results
Primary
Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While in Study
A TEAE is any adverse event, 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 48 weeks (13 injections), not including base study
Population: All participants who received at least 1 dose of study drug are included in the safety population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medisorb Naltrexone 380 mg | Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While in Study | 143 Participants |
| Medisorb Naltrexone 190 mg | Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While in Study | 130 Participants |