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

Primary Purpose

Alcoholism

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Medisorb naltrexone 190 mg

Medisorb naltrexone 380 mg

Placebo matching Medisorb naltrexone 190 mg

Placebo matching Medisorb naltrexone 380 mg

About this trial

This is an interventional treatment trial for Alcoholism focused on measuring Alcoholism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Medisorb naltrexone 190 mg

Medisorb naltrexone 380 mg

Placebo for Medisorb naltrexone 190 mg

Placebo for Medisorb naltrexone 380 mg

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

NCT ID

NCT01218958

First Posted

October 8, 2010

Last Updated

June 8, 2017

Sponsor

Alkermes, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01218958

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

February 2002 (undefined)

Primary Completion Date

September 2003 (Actual)

Study Completion Date

September 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Alkermes, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcoholism

Keywords

Alcoholism

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

624 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Medisorb naltrexone 190 mg

Arm Type

Experimental

Arm Title

Medisorb naltrexone 380 mg

Arm Type

Experimental

Arm Title

Placebo for Medisorb naltrexone 190 mg

Arm Type

Placebo Comparator

Arm Title

Placebo for Medisorb naltrexone 380 mg

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Medisorb naltrexone 190 mg

Other Intervention Name(s)

naltrexone for extended-release injectable suspension

Intervention Description

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

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

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

Intervention Type

Drug

Intervention Name(s)

Placebo matching Medisorb naltrexone 190 mg

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo matching Medisorb naltrexone 380 mg

Other Intervention Name(s)

Placebo matching VIVITROL 380 mg

Intervention Description

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

Primary Outcome Measure Information:

Title

Percentage of Heavy Drinking Days Over the Treatment Period

Description

Time Frame

Baseline through Week 24 (168 days)

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

24 weeks (Baseline to Week 24)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bernard Silverman, MD

Organizational Affiliation

Alkermes, Inc.

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

15811981

Citation

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. Erratum In: JAMA. 2005 Apr 27;293(16):1978. JAMA. 2005 Jun 15:293(23):2864.

Results Reference

result

PubMed Identifier

17873686

Citation

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.

Results Reference

result

PubMed Identifier

17588491

Citation

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.

Results Reference

result

PubMed Identifier

18241321

Citation

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.

Results Reference

result

PubMed Identifier

18348601

Citation

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.

Results Reference

result

PubMed Identifier

19053979

Citation

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.

Results Reference

result

PubMed Identifier

18775624

Citation

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.

Results Reference

result

PubMed Identifier

21769033

Citation

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.

Results Reference

result

PubMed Identifier

21575016

Citation

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.

Results Reference

result

Learn more about this trial

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

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