AzTrials
AzTrials

AlcoholismPhase 3NCT01218958

ALK21-003: Study of Medisorb® Naltrexone (VIVITROL®) in Alcohol-Dependent Adults

A Phase 3 study testing Medisorb naltrexone 190 mg and Medisorb naltrexone 380 mg in people with Alcoholism, run by Alkermes, Inc..

Completed

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

Official record
Search all trials

Trial summary

This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study conducted in subjects diagnosed with alcohol dependence as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Ed. (DSM-IV). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Alcoholism
What is being tested?
Medisorb naltrexone 190 mg and Medisorb naltrexone 380 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
624 participants
Where
No sites listed yet
Study dates
Feb 2002to Sep 2003
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:

  • Diagnosis of alcohol dependence based on Diagnostic and Statistical Manual of Mental Disorders, 4th Ed. (DSM-IV) criteria
  • Male or non-pregnant, non-lactating female
  • Able to provide TimeLine Follow-Back (TLFB) alcohol consumption information for 90-day period before detoxification and/or screening
  • At least 2 episodes of heavy alcohol drinking per week during the 30 days before detoxification and/or screening
  • Negative urine toxicological screen for opiates on day of randomization
  • Noncustodial, stable residence and phone plus 1 contact with verifiable address and phone

Primary Exclusion Criteria:

  • Evidence of hepatic failure including: ascites, prolonged prothrombin time (PT) (international normalized ratio [INR] ≥1.7), bilirubin >10% above upper limit of normal (ULN) and/or esophageal variceal disease
  • Active hepatitis and/or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) higher than 3xULN
  • History of pancreatitis
  • Major depression with suicidal ideation, psychosis, bipolar disorder, or psychiatric disorders that would compromise subject's ability to complete the study
  • Current dependence (within past year) per DSM-IV criteria to benzodiazepines, opioids or cocaine
  • Use of benzodiazepines and/or Ambien® (zolpidem tartrate) within 7 days prior to first dose of study medication
  • Greater than 7 days inpatient treatment for substance use disorders within 30 days of randomization
  • Use of any opioids and/or methadone within 14 days of screening, or likely requiring opioid therapy during study period
  • Use of oral naltrexone or disulfiram within 14 days of screening
  • Known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or polylactide-co-glycolide (PLG)

About this study

Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Medisorb® Naltrexone in Alcohol-Dependent Adults

This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study conducted in subjects diagnosed with alcohol dependence as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Ed. (DSM-IV). Subjects were randomized (2:2:1:1) to receive intramuscular (IM) injections of Medisorb® naltrexone 190 mg, Medisorb naltrexone 380 mg, placebo for Medisorb naltrexone 190 mg, or placebo for Medisorb naltrexone 380 mg (VIVITROL®). Study drug was administered every 4 weeks for a total of 6 injections.

Read the detailed description

All subjects received standardized biopsychosocial support therapy (BRENDA Approach [Volpicelli, JR [2001]; Guilford Press: New York]) at each visit.

Subjects who completed this study (ie, received 6 injections of study drug and completed all study visits) and continued to meet eligibility criteria were given the option to enroll in extension study ALK21-003EXT (NCT01218971). A second extension, Study ALK21-010 (NCT00156923), was conducted subsequent to ALK21-003EXT.

Conditions
Alcoholism
Being tested
Medisorb naltrexone 190 mg, Medisorb naltrexone 380 mg, Placebo matching Medisorb naltrexone 190 mg, Placebo matching Medisorb naltrexone 380 mg
Keywords
Alcoholism
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medisorb naltrexone 190 mgDrug

    Also called naltrexone for extended-release injectable suspension

    Intramuscular (IM) injection once every 4 weeks for a total of 6 administrations.

  • Medisorb naltrexone 380 mgDrug

    Also called VIVITROL 380 mg, naltrexone for extended-release injectable suspension

    IM injection once every 4 weeks for a total of 6 administrations.

  • Placebo matching Medisorb naltrexone 190 mgDrug

    IM injection once every 4 weeks for a total of 6 administrations.

  • Placebo matching Medisorb naltrexone 380 mgDrug

    Also called Placebo matching VIVITROL 380 mg

    IM injection once every 4 weeks for a total of 6 administrations.

Study groups in NCT01218958
Study groupRoleWhat they receive
Medisorb naltrexone 190 mgExperimentalNot described
Receives: Drug: Medisorb naltrexone 190 mg
Medisorb naltrexone 380 mgExperimentalNot described
Receives: Drug: Medisorb naltrexone 380 mg
Placebo for Medisorb naltrexone 190 mgPlacebo comparatorNot described
Receives: Drug: Placebo matching Medisorb naltrexone 190 mg
Placebo for Medisorb naltrexone 380 mgPlacebo comparatorNot described
Receives: Drug: Placebo matching Medisorb naltrexone 380 mg

What is being measured

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

  1. Percentage of Heavy Drinking Days Over the Treatment Period

    Drinking rates were assessed from participants' self-reports using the validated Timeline Follow-Back (TLFB) method. Using a TLFB calendar, participants reported the number of days they had consumed alcohol along with the amount they consumed on each day. A heavy drinking day was defined as ≥5 drinks/day for men and ≥4 drinks/day for women.

    Measured: Baseline through Week 24 (168 days)

Secondary outcomes (1)

  1. Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE)

    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).

    Measured: 24 weeks (Baseline to Week 24)

Timeline

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

  1. First posted13 Oct 2010 (estimated)
  2. Study startFeb 2002
  3. Primary completionSep 2003
  4. Study completionSep 2003

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
624 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01218958
Sponsor's protocol ID
ALK21-003
Status last verified
Jun 2017
First submitted
8 Oct 2010
Last updated
11 Jul 2017
Data monitoring committee
No

Publications

  • Garbutt JC, Kranzler HR, O'Malley SS, Gastfriend DR, Pettinati HM, Silverman BL, Loewy JW, Ehrich EW; Vivitrex Study Group. Efficacy and tolerability of long-acting injectable naltrexone for alcohol dependence: a randomized controlled trial. JAMA. 2005 Apr 6;293(13):1617-25. doi: 10.1001/jama.293.13.1617.

    PubMed 15811981

  • O'Malley SS, Garbutt JC, Gastfriend DR, Dong Q, Kranzler HR. Efficacy of extended-release naltrexone in alcohol-dependent patients who are abstinent before treatment. J Clin Psychopharmacol. 2007 Oct;27(5):507-12. doi: 10.1097/jcp.0b013e31814ce50d.

    PubMed 17873686

  • Gastfriend DR, Garbutt JC, Pettinati HM, Forman RF. Reduction in heavy drinking as a treatment outcome in alcohol dependence. J Subst Abuse Treat. 2007 Jul;33(1):71-80. doi: 10.1016/j.jsat.2006.09.008. Epub 2007 Feb 22.

    PubMed 17588491

  • Lucey MR, Silverman BL, Illeperuma A, O'Brien CP. Hepatic safety of once-monthly injectable extended-release naltrexone administered to actively drinking alcoholics. Alcohol Clin Exp Res. 2008 Mar;32(3):498-504. doi: 10.1111/j.1530-0277.2007.00593.x. Epub 2008 Jan 30.

    PubMed 18241321

  • Ciraulo DA, Dong Q, Silverman BL, Gastfriend DR, Pettinati HM. Early treatment response in alcohol dependence with extended-release naltrexone. J Clin Psychiatry. 2008 Feb;69(2):190-5. doi: 10.4088/jcp.v69n0204.

    PubMed 18348601

  • Pettinati HM, Gastfriend DR, Dong Q, Kranzler HR, O'Malley SS. Effect of extended-release naltrexone (XR-NTX) on quality of life in alcohol-dependent patients. Alcohol Clin Exp Res. 2009 Feb;33(2):350-6. doi: 10.1111/j.1530-0277.2008.00843.x. Epub 2008 Nov 25.

    PubMed 19053979

  • Lapham S, Forman R, Alexander M, Illeperuma A, Bohn MJ. The effects of extended-release naltrexone on holiday drinking in alcohol-dependent patients. J Subst Abuse Treat. 2009 Jan;36(1):1-6. doi: 10.1016/j.jsat.2008.07.001. Epub 2008 Sep 4.

    PubMed 18775624

  • Cisler RA, Silverman BL, Gromov I, Gastfriend DR. Impact of treatment with intramuscular, injectable, extended-release naltrexone on counseling and support group participation in patients with alcohol dependence. J Addict Med. 2010 Sep;4(3):181-5. doi: 10.1097/ADM.0b013e3181c82207.

    PubMed 21769033

  • Pettinati HM, Silverman BL, Battisti JJ, Forman R, Schweizer E, Gastfriend DR. Efficacy of extended-release naltrexone in patients with relatively higher severity of alcohol dependence. Alcohol Clin Exp Res. 2011 Oct;35(10):1804-11. doi: 10.1111/j.1530-0277.2011.01524.x. Epub 2011 May 16.

    PubMed 21575016

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Medisorb naltrexone 190 mg and Medisorb naltrexone 380 mg in people with Alcoholism, 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 11 Jul 2017. 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 7 Dec 2010). 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 Heavy Drinking Days Over the Treatment Period (time frame: Baseline through Week 24 (168 days)). 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 NCT01218958, which also lists 9 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 11 Jul 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in