Back to resultsALK21-006: Long-Term Study of Medisorb® Naltrexone (VIVITROL®)
Primary Purpose
Alcoholism
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Medisorb naltrexone 380 mg
Oral naltrexone 50 mg
Sponsored by
About this trial
This is an interventional treatment trial for Alcoholism focused on measuring Alcoholism, Alcohol dependence
Eligibility Criteria
Primary Inclusion Criteria:
- Current diagnosis of DSM-IV alcohol dependence and/or diagnosis of DSM-IV opiate dependence within 3 months prior to screening
- 18 years or older
- Desire to seek treatment for alcohol and/or opiate abuse/dependence
- Agree to use contraception for the study duration if of childbearing potential
- Written informed consent and willingness to perform study procedures
- Stable address and phone and at least 1 source of contact information (eg, family member, significant other)
Primary Exclusion Criteria:
- Presence of opiates in the urine (as determined by urine drug test) on Day 0 prior to naltrexone treatment
- Clinically significant medical/psychological condition or abnormality at screening (ie, physical examination, electrocardiogram [ECG], hematology or blood chemistry evaluation, or urinalysis findings)
- Clinically significant active hepatitis or hepatic failure evidenced by 1 of the following: aspartate transaminase (AST) or alanine transaminase (ALT) higher than 3 times the upper limit of normal (3xULN), hyperbilirubinemia (bilirubin >10% above ULN), creatine phosphokinase (CPK) higher than 10xULN, prolonged prothrombin time(international normalized ratio ≥1.7), ascites, or esophageal variceal disease
- Manifestation of suicidal ideation, psychotic symptoms (including significant violent behavior), or psychiatric disorders that would compromise ability to complete the study
- Participation in a formal methadone program currently or within prior 3 years
- More than 2 prior medically supervised detoxification treatments in prior 3 years
- Pregnancy or lactation
- Current prescribed opiate therapy, or receipt of opiates within 7 days prior to study drug dosing, or ongoing medical condition likely to require prescribed opiate therapy during study period
- Failed naloxone challenge on Day 0 (the challenge could be repeated up to 2 times, with at least 24 hours between attempts)
- Participation in a clinical trial within 30 days of screening
- Previous enrollment in a VIVITROL clinical trial
- Receipt of any drug product administered as a gluteal injection within 180 days prior to Day 0 or anticipated need for gluteal injections during study period
- Intolerance and/or hypersensitivity to naltrexone, naloxone, or polylactide-co-polymers such as polylactide-co-glycolide (PLG)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Medisorb naltrexone 380 mg (VIVITROL)
Oral naltrexone 50 mg
Arm Description
Outcomes
Primary Outcome Measures
Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study
A TEAE was defined as any adverse event (AE) that started or worsened on or after the administration of the first dose of study medication through 30 days after the end of study treatment.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01218997
Brief Title
ALK21-006: Long-Term Study of Medisorb® Naltrexone (VIVITROL®)
Official Title
A Randomized, Open Label, Long-Term, Multi-Center Study of the Safety of Medisorb® Naltrexone
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
March 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Alkermes, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This was a Phase 3 multicenter randomized, open-label, safety study assessing the safety of repeat doses of Medisorb® naltrexone 380 mg (VIVITROL®) administered for up to 1 year to adults with alcohol and/or opioid dependence as defined by Diagnostic and Statistical Manual of Mental Health Disorders (DSM-IV) criteria. Eligible subjects were randomized in a 6:1 ratio to receive 1 of the following regimens: a single intramuscular (IM) injection of VIVITROL administered once every 4 weeks or oral naltrexone 50 mg administered daily.
Detailed Description
Safety evaluations included physical examinations, electrocardiograms (ECGs), laboratory measures (including plasma concentrations of naltrexone and 6β-naltrexol), assessments of injection sites, and adverse events (AEs).
All subjects received psychosocial support at each study visit for the duration of the study, with interim telephone contact 2 weeks after each monthly visit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism
Keywords
Alcoholism, Alcohol dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
436 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Medisorb naltrexone 380 mg (VIVITROL)
Arm Type
Experimental
Arm Title
Oral naltrexone 50 mg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Medisorb naltrexone 380 mg
Other Intervention Name(s)
VIVITROL® 380 mg, Naltrexone for extended-release injectable suspension
Intervention Description
Administered via intramuscular (IM) injection once every 4 weeks for up to 1 year.
Intervention Type
Drug
Intervention Name(s)
Oral naltrexone 50 mg
Other Intervention Name(s)
Revia®
Intervention Description
Tablet taken orally once daily for up to 1 year
Primary Outcome Measure Information:
Title
Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study
Description
A TEAE was defined as any adverse event (AE) that started or worsened on or after the administration of the first dose of study medication through 30 days after the end of study treatment.
Time Frame
up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Primary Inclusion Criteria:
Current diagnosis of DSM-IV alcohol dependence and/or diagnosis of DSM-IV opiate dependence within 3 months prior to screening
18 years or older
Desire to seek treatment for alcohol and/or opiate abuse/dependence
Agree to use contraception for the study duration if of childbearing potential
Written informed consent and willingness to perform study procedures
Stable address and phone and at least 1 source of contact information (eg, family member, significant other)
Primary Exclusion Criteria:
Presence of opiates in the urine (as determined by urine drug test) on Day 0 prior to naltrexone treatment
Clinically significant medical/psychological condition or abnormality at screening (ie, physical examination, electrocardiogram [ECG], hematology or blood chemistry evaluation, or urinalysis findings)
Clinically significant active hepatitis or hepatic failure evidenced by 1 of the following: aspartate transaminase (AST) or alanine transaminase (ALT) higher than 3 times the upper limit of normal (3xULN), hyperbilirubinemia (bilirubin >10% above ULN), creatine phosphokinase (CPK) higher than 10xULN, prolonged prothrombin time(international normalized ratio ≥1.7), ascites, or esophageal variceal disease
Manifestation of suicidal ideation, psychotic symptoms (including significant violent behavior), or psychiatric disorders that would compromise ability to complete the study
Participation in a formal methadone program currently or within prior 3 years
More than 2 prior medically supervised detoxification treatments in prior 3 years
Pregnancy or lactation
Current prescribed opiate therapy, or receipt of opiates within 7 days prior to study drug dosing, or ongoing medical condition likely to require prescribed opiate therapy during study period
Failed naloxone challenge on Day 0 (the challenge could be repeated up to 2 times, with at least 24 hours between attempts)
Participation in a clinical trial within 30 days of screening
Previous enrollment in a VIVITROL clinical trial
Receipt of any drug product administered as a gluteal injection within 180 days prior to Day 0 or anticipated need for gluteal injections during study period
Intolerance and/or hypersensitivity to naltrexone, naloxone, or polylactide-co-polymers such as polylactide-co-glycolide (PLG)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard L. Silverman, MD
Organizational Affiliation
Alkermes, Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
ALK21-006: Long-Term Study of Medisorb® Naltrexone (VIVITROL®)
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