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Opiate DependencePhase 3NCT00678418

ALK21-013: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) in Adults With Opioid Dependence

A Phase 3 study testing VIVITROL® 380 mg in people with Opiate Dependence, run by Alkermes, Inc. at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase 3 multi-center trial designed to evaluate the clinical efficacy and safety of VIVITROL® (Medisorb® naltrexone 380 mg) versus placebo when administered to adults upon discharge from inpatient treatment for opioid dependence. The study was conducted in 2 parts, Part A and Part B. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Opiate 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
250 participants
Where
1 siteRussia
Study dates
Jun 2008to Nov 2010
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Primary Inclusion Criteria:

  • Written, informed consent
  • 18 years of age or older
  • Current diagnosis of opioid dependence, based on Diagnostic and Statistical Manual of Mental Health Disorders, 4th Ed. (DSM-IV-TR) criteria
  • Voluntarily seeking treatment for opioid dependence
  • Completing or recently completed up to 30 days of inpatient treatment for opioid detoxification, and off all opioids (including buprenorphine and methadone) for at least 7 days
  • Noncustodial, stable residence and phone, plus 1 contact with verifiable address and phone
  • Significant other (eg, spouse, relative) willing to supervise compliance with the study visit schedule and procedures
  • Agree to use contraception for study duration if of childbearing potential

Primary Exclusion Criteria:

  • Pregnancy or lactation
  • Clinically significant medical condition or observed abnormalities (eg: physical exam, electrocardiogram (ECG), lab and/or urinalysis findings)
  • Positive naloxone challenge test at randomization (Day 0)
  • Evidence of hepatic failure including: ascites, bilirubin >10% above upper limit of normal (ULN) and/or esophageal variceal disease
  • Past or present history of an acquired immunodeficiency syndrome (AIDS)-indicator disease in HIV-infected subjects
  • Active hepatitis and/or aspartate aminotransferase (AST), alanine aminotransferase(ALT) >3xULN
  • Current major depression with suicidal ideation, psychosis, bipolar disorder, or any psychiatric disorder that would compromise ability to complete the study
  • Recent history (within 6 months prior to screening) of suicidal ideation or attempt
  • Dependence within prior year based on DSM-IV-TR, to any drugs other than prescription opioids or heroin, caffeine, marijuana, or nicotine
  • Active alcohol dependence within prior 6 months
  • Current alcohol use disorder that would, in the Investigator's opinion, preclude successful completion of the study
  • Positive urine drug test for cocaine, benzodiazepines, or amphetamines at screening
  • Use of oral naltrexone for 7 consecutive days within 60 days prior to screening
  • Known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or polylactide-co-glycolide (PLG)

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • Ethics Committee within the Federal Authority for Healthcare and Social Development Regulation

    Moscow, 109074

Other trials in Russia

About this study

Official title: Efficacy and Safety of VIVITROL® (Naltrexone for Extended-release Injectable Suspension) in Adults With Opioid Dependence

This is a Phase 3 multi-center trial designed to evaluate the clinical efficacy and safety of VIVITROL® (Medisorb® naltrexone 380 mg) versus placebo when administered to adults upon discharge from inpatient treatment for opioid dependence.

The study was conducted in 2 parts, Part A and Part B. The clinical portion of both parts has completed. Results for Part B are not yet available.

Read the detailed description

Part A was a double-blind, randomized, placebo-controlled assessment of the efficacy and safety of 24 weeks of monthly treatment with VIVITROL compared to placebo in opioid-dependent adults.

Subjects who completed Part A could choose to continue to Part B, which was an open-label extension to assess longer-term safety, durability of effect, health economics, and quality of life (QOL) in the continuing study population for up to 1 year.

At the conclusion of both parts, each completing subject will have received a total of up to 19 injections of study drug over approximately 1.5 years.

Dosing was performed by the principal investigator or designated study staff member.

All subjects received standardized, manual-based psychosocial support at each scheduled visit. Opioid use was tracked through urine drug testing and subjects' self reports. Other evaluations for efficacy and safety, health economics, and quality of life were routinely conducted throughout the study.

Being tested
VIVITROL® 380 mg, Placebo
Keywords
Addiction, Opiate dependence, Inpatient detoxification, opioid dependence, heroin dependence
Medical subject headings
Opioid-Related Disorders, Behavior, Addictive, Heroin Dependence

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 intramuscular (IM) injection once every 4 weeks for 24 weeks during Part A, followed by once every 4 weeks for 52 weeks in Part B.

  • PlaceboDrug

    Administered via IM injection once every 4 weeks for 24 weeks during Part A, followed by VIVITROL® 380 mg via IM injection once every 4 weeks for 52 weeks in Part B.

Study groups in NCT00678418
Study groupRoleWhat they receive
VIVITROL® 380 mgExperimentalNot described
Receives: Drug: VIVITROL® 380 mg
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage (%) of Opioid-free Weeks Per Subject in Double-blind Period (Part A)

    Included are data from the last 20 weeks of the 24-week double-blind treatment period (Part A). Response profiles for each Arm are based on subjects' individual rates of weekly opioid-free data, including negative urine test results, attendance at study visits, and self-reports of opioid use/non-use.

    Measured: 20 weeks

Secondary outcomes (4)

  1. Days to Discontinuation During Part A

    Defined as the duration of study participation and calculated as the number of days from Dose 1 to the day of study discontinuation.

    Measured: 168 days (24 weeks)

  2. Craving Score: Change From Baseline

    Measured using subjects' response on a validated Visual Analog Scale at prespecified weekly visits throughout Part A, with comparison of baseline to end of Part A. The scale ranged from 0 ("No craving") to 100 ("highest possible craving").

    Measured: Baseline to 6 months (24 weeks)

  3. Incidence of Subjects Who Relapsed to Physiologic Opioid Dependence During the 24-week Treatment Period (Part A)

    Assessment of relapse to physiologic opioid dependence was based on individual subjects' results on the naloxone challenge test. A positive naloxone challenge test result was considered as a relapse to physiologic opioid dependence.

    Measured: 24 Weeks

  4. Change in Percentage of Self-reported Opioid-free Days From Baseline to Week 24

    Opioid use was measured using subjects' entries on a validated Timeline FollowBack (TLFB) calendar in which they recorded their use/non-use of opioids each day.

    Measured: 24 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionOct 2009
  4. Study completionNov 2010

Resources

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
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00678418
Sponsor's protocol ID
ALK21-013
Status last verified
Dec 2016
First submitted
14 May 2008
Last updated
10 Feb 2017
Data monitoring committee
No

Publications

  • Krupitsky E, Nunes EV, Ling W, Gastfriend DR, Memisoglu A, Silverman BL. Injectable extended-release naltrexone (XR-NTX) for opioid dependence: long-term safety and effectiveness. Addiction. 2013 Sep;108(9):1628-37. doi: 10.1111/add.12208. Epub 2013 May 24.

    PubMed 23701526

  • Nunes EV, Krupitsky E, Ling W, Zummo J, Memisoglu A, Silverman BL, Gastfriend DR. Treating Opioid Dependence With Injectable Extended-Release Naltrexone (XR-NTX): Who Will Respond? J Addict Med. 2015 May-Jun;9(3):238-43. doi: 10.1097/ADM.0000000000000125.

    PubMed 25901451

  • Mitchell MC, Memisoglu A, Silverman BL. Hepatic safety of injectable extended-release naltrexone in patients with chronic hepatitis C and HIV infection. J Stud Alcohol Drugs. 2012 Nov;73(6):991-7. doi: 10.15288/jsad.2012.73.991.

    PubMed 23036218

  • Kornor H, Lobmaier PPK, Kunoe N. Sustained-release naltrexone for opioid dependence. Cochrane Database Syst Rev. 2025 May 9;5(5):CD006140. doi: 10.1002/14651858.CD006140.pub3.

    PubMed 40342086

  • Krupitsky E, Zvartau E, Blokhina E, Verbitskaya E, Wahlgren V, Tsoy-Podosenin M, Bushara N, Burakov A, Masalov D, Romanova T, Tyurina A, Palatkin V, Slavina T, Pecoraro A, Woody GE. Randomized trial of long-acting sustained-release naltrexone implant vs oral naltrexone or placebo for preventing relapse to opioid dependence. Arch Gen Psychiatry. 2012 Sep;69(9):973-81. doi: 10.1001/archgenpsychiatry.2012.1a.

    PubMed 22945623

  • Krupitsky E, Nunes EV, Ling W, Illeperuma A, Gastfriend DR, Silverman BL. Injectable extended-release naltrexone for opioid dependence: a double-blind, placebo-controlled, multicentre randomised trial. Lancet. 2011 Apr 30;377(9776):1506-13. doi: 10.1016/S0140-6736(11)60358-9.

    PubMed 21529928

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing VIVITROL® 380 mg in people with Opiate Dependence, run by Alkermes, Inc. at 1 site in Russia.

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 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

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 21 Jan 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?

Percentage (%) of Opioid-free Weeks Per Subject in Double-blind Period (Part A) (time frame: 20 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00678418, which also lists 6 linked publications.

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 10 Feb 2017.

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