NCT01218958

Brief 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). 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
624

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2002

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
7.1 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 13, 2010

Completed
2 months until next milestone

Results Posted

Study results publicly available

December 7, 2010

Completed
Last Updated

July 11, 2017

Status Verified

June 1, 2017

Enrollment Period

1.6 years

First QC Date

October 8, 2010

Results QC Date

November 5, 2010

Last Update Submit

June 8, 2017

Conditions

Alcoholism

Keywords

Alcoholism

Outcome Measures

Primary Outcomes (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.

    Baseline through Week 24 (168 days)

Secondary Outcomes (1)

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

    24 weeks (Baseline to Week 24)

Study Arms (4)

Medisorb naltrexone 190 mg

EXPERIMENTAL
Drug: Medisorb naltrexone 190 mg

Medisorb naltrexone 380 mg

EXPERIMENTAL
Drug: Medisorb naltrexone 380 mg

Placebo for Medisorb naltrexone 190 mg

PLACEBO COMPARATOR
Drug: Placebo matching Medisorb naltrexone 190 mg

Placebo for Medisorb naltrexone 380 mg

PLACEBO COMPARATOR
Drug: Placebo matching Medisorb naltrexone 380 mg

Interventions

Medisorb naltrexone 190 mgDRUG

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

Also known as: naltrexone for extended-release injectable suspension
Medisorb naltrexone 190 mg
Medisorb naltrexone 380 mgDRUG

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

Also known as: VIVITROL 380 mg, naltrexone for extended-release injectable suspension
Medisorb naltrexone 380 mg
Placebo matching Medisorb naltrexone 190 mgDRUG

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

Placebo for Medisorb naltrexone 190 mg
Placebo matching Medisorb naltrexone 380 mgDRUG

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

Also known as: Placebo matching VIVITROL 380 mg
Placebo for Medisorb naltrexone 380 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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.

    PMID: 15811981RESULT

  • 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.

    PMID: 17873686RESULT

  • 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.

    PMID: 17588491RESULT

  • 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.

    PMID: 18241321RESULT

  • 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.

    PMID: 18348601RESULT

  • 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.

    PMID: 19053979RESULT

  • 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.

    PMID: 18775624RESULT

  • 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.

    PMID: 21769033RESULT

  • 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.

    PMID: 21575016RESULT

MeSH Terms

Conditions

Alcoholism

Interventions

Naltrexonevivitrol

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

NaloxoneMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Results Point of Contact

Title
Bernard L. Silverman, VP, Clinical Development
Organization
Alkermes, Inc.
bernard.silverman@alkermes.com
781-609-6000

Study Officials

  • Bernard Silverman, MD

    Alkermes, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 8, 2010

First Posted

October 13, 2010

Study Start

February 1, 2002

Primary Completion

September 1, 2003

Study Completion

September 1, 2003

Last Updated

July 11, 2017

Results First Posted

December 7, 2010

Record last verified: 2017-06