Alcohol DependencePhase 3NCT00501631
ALK21-014: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) After Enforced Abstinence
A Phase 3 study testing VIVITROL 380 mg in people with Alcohol Dependence, run by Alkermes, Inc..
Trial summary
VIVITROL is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL. This Phase 3B trial was designed to evaluate the efficacy and safety of VIVITROL versus placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Dependence
- What is being tested?
- VIVITROL 380 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Mar 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Primary Inclusion Criteria:
- Current diagnosis of alcohol dependence, meeting at least 5 of DSM-IV criteria
- Expected to complete inpatient treatment for alcohol dependence within 24 hours of randomization
- Must have 7-21 days, inclusive, of inpatient treatment for alcohol dependence prior to first dose
- Negative urine toxicological screen for opioids on the day of randomization
- Women of childbearing potential must agree to use an approved method of contraception for the study duration
Primary Exclusion Criteria:
- Pregnancy or lactation
- Evidence of hepatic failure including: ascites, bilirubin >10% above upper limit of normal and/or esophageal variceal disease
- Current dependence (within the past year) to benzodiazepines, opioids or cocaine by DSM-IV criteria
- Use of any opioids and/or methadone within 14 days prior to the screening visit, or subjects likely to require opioid therapy during the study period
- Use of oral naltrexone, acamprosate, or disulfiram within 14 days prior to screening
- Known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or PLG
- Parole, probation, or pending legal proceedings having the potential for incarceration during the study period
About this study
Official title: Efficacy and Safety of VIVITROL® in Adults Completing Inpatient Treatment for Alcohol Dependence
VIVITROL is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL. This Phase 3B trial was designed to evaluate the efficacy and safety of VIVITROL versus placebo. Injections were administered to patients in whom abstinence was enforced by a period of inpatient hospitalization of 7 to 21 days.
Read the detailed description
The study consisted of 2 parts, Part A and Part B. Part A was a double-blind, placebo-controlled assessment of safety and efficacy of VIVITROL versus placebo for 3 months. Part B was an open-label extension to assess longer-term safety, durability of effect, and health economics of VIVITROL when administered for up to 9 additional months.
- Conditions
- Alcohol Dependence
- Being tested
- VIVITROL 380 mg, Placebo for VIVITROL 380 mg
- Keywords
- Addiction, Alcoholism, Inpatient detoxification
- Medical subject headings
- Alcoholism, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIVITROL 380 mgDrug
Also called naltrexone for extended-release injectable suspension, Medisorb naltrexone
Administered via IM injection once every 4 weeks.
Placebo for VIVITROL 380 mgDrug
Administered via IM injection once every 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| VIVITROL 380 mg | Active comparator | Administered via intramuscular (IM) injection once every 4 weeks. Receives: Drug: VIVITROL 380 mg |
| Placebo for VIVITROL 380 mg | Placebo comparator | Administered via IM injection once every 4 weeks. Receives: Drug: Placebo for VIVITROL 380 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Percentage of Participants by Heavy Drinking Rate
Cumulative percentage (%) of subjects reporting heavy drinking by category reflecting the various cut-offs for percentage of days that were heavy drinking days. A "heavy drinking day" was defined as 4 or more alcohol drinks in 1 day for women, and 5 or more alcohol drinks in 1 day for men. The Timeline Follow-Back (TLFB) method (Sobell \& Sobell: Humana Press, 1992) was utilized to collect subjects' daily drinking information (ie, the number of drinks consumed per day per subject which was retrospectively recalled and recorded in a diary).
Measured: up to 12 weeks
Secondary outcomes (1)
Longer-term Safety of VIVITROL
Number of subjects reporting at least 1 treatment-emergent adverse event (TEAE) while on study.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionJan 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alkermes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bernard L. Silverman, MD, Study director, Alkermes, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00501631
- Sponsor's protocol ID
- ALK21-014
- Status last verified
- Sep 2011
- First submitted
- 12 Jul 2007
- Last updated
- 22 Sep 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of VIVITROL® in Adults Completing Inpatient Treatment for Alcohol Dependence
- ClinicalTrials.gov ID
- NCT00501631
- Acronym / sponsor ID
- ALK21-014
- Conditions
- Alcohol Dependence
- Keywords
- Addiction, Alcoholism, Inpatient detoxification
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 16 Jul 2007 (estimated)
- Results
- Posted 13 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
VIVITROL is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL. This Phase 3B trial was designed to evaluate the efficacy and safety of VIVITROL versus placebo. Injections were administered to patients in whom abstinence was enforced by a period of inpatient hospitalization of 7 to 21 days.
Detailed description
The study consisted of 2 parts, Part A and Part B. Part A was a double-blind, placebo-controlled assessment of safety and efficacy of VIVITROL versus placebo for 3 months. Part B was an open-label extension to assess longer-term safety, durability of effect, and health economics of VIVITROL when administered for up to 9 additional months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VIVITROL 380 mg | Active comparator | Drug: VIVITROL 380 mgAdministered via intramuscular (IM) injection once every 4 weeks. |
| Placebo for VIVITROL 380 mg | Placebo comparator | Drug: Placebo for VIVITROL 380 mgAdministered via IM injection once every 4 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIVITROL 380 mgAlso: naltrexone for extended-release injectable suspension, Medisorb naltrexoneAdministered via IM injection once every 4 weeks. | Drug | VIVITROL 380 mg |
| Placebo for VIVITROL 380 mgAdministered via IM injection once every 4 weeks. | Drug | Placebo for VIVITROL 380 mg |
Primary outcome
Cumulative Percentage of Participants by Heavy Drinking Rate
Time frame: up to 12 weeks
Cumulative percentage (%) of subjects reporting heavy drinking by category reflecting the various cut-offs for percentage of days that were heavy drinking days. A "heavy drinking day" was defined as 4 or more alcohol drinks in 1 day for women, and 5 or more alcohol drinks in 1 day for men. The Timeline Follow-Back (TLFB) method (Sobell \& Sobell: Humana Press, 1992) was utilized to collect subjects' daily drinking information (ie, the number of drinks consumed per day per subject which was retrospectively recalled and recorded in a diary).
1 secondary outcome
Longer-term Safety of VIVITROL
Time frame: up to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard L. Silverman, MD study director
Alkermes, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VIVITROL 380 mg in people with Alcohol Dependence, run by Alkermes, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Percentage of Participants by Heavy Drinking Rate (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2011.