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

Alcoholism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01218958
• Other study ID #: ALK21-003
• Status: Completed
• Phase: Phase 3
• First received: October 8, 2010
• Last updated: December 9, 2010
• Start date: February 2002
• Est. completion date: September 2003

Study information

• Verified date: December 2010
• Source: Alkermes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 624
• Est. completion date: September 2003
• Est. primary completion date: September 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholism

Intervention

Drug:
• Medisorb naltrexone 190 mg
Intramuscular (IM) injection once every 4 weeks for a total of 6 administrations.
• Medisorb naltrexone 380 mg
IM injection once every 4 weeks for a total of 6 administrations.
• Placebo matching Medisorb naltrexone 190 mg
IM injection once every 4 weeks for a total of 6 administrations.
• Placebo matching Medisorb naltrexone 380 mg
IM injection once every 4 weeks for a total of 6 administrations.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

References & Publications (1)

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 Ap — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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).	24 weeks (Baseline to Week 24)	No