NCT00511836

Brief Summary

This was a study of the effects of VIVITROL® on alcohol cue-induced craving and the associated brain activation patterns in alcohol-dependent adults who had recently completed alcohol detoxification and were seeking further treatment for their alcohol dependence. The study was powered to to detect whether VIVITROL attenuates or blocks the BOLD signal increases in response to alcohol-related cues. In the double-blind portion, subjects received a single administration of study drug (VIVITROL 380 mg or placebo). Subjects who completed the double-blind portion could opt to continue to the open-label portion and receive 2 additional months of treatment with VIVITROL 380 mg.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2007

Typical duration for phase_4

Geographic Reach
1 country

1 active site

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

July 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 2, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
1.2 years 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

1.9 years

First QC Date

August 2, 2007

Results QC Date

June 10, 2010

Last Update Submit

June 8, 2017

Conditions

Alcohol Dependence

Keywords

alcoholismaddictionalcohol detoxification

Outcome Measures

Primary Outcomes (3)

  • Change From Baseline in Blood Oxygen-level-dependent (BOLD) Signal Activation Values Detected in the Reward Circuitry of the Brain in Alcohol-dependent Subjects After Presentation of Alcohol-related Cues.

    As was standard among fMRI studies conducted at the study site at the time, a change in BOLD signal in the range of 5% to 6% in anterior cingulate as measured using a 3T magnet,is considered highly significant in block-designed experiments.

    14 days (Baseline to Day 14)

  • Change From Baseline in BOLD Signal Activation Values for the Inferior Frontal Gyrus

    14 days (Baseline to Day 14)

  • Change From Baseline in BOLD Signal Activation Values in the Reward Circuitry

    14 days (Baseline to Day 14)

Secondary Outcomes (2)

  • Change From Baseline in Obsessive-Compulsive Drinking Scale (OCDS) Score in Alcohol-dependent Subjects

    28 days (Baseline to Day 28)

  • Change From Baseline in Daily Craving Score in Alcohol-dependent Subjects (Actiwatch Data)

    28 days (Baseline to Day 28)

Study Arms (2)

VIVITROL 380 mg

EXPERIMENTAL
Drug: VIVITROL 380 mg

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

VIVITROL 380 mgDRUG

Administered via intramuscular (IM) injection once during the double-blind phase and for 2 additional injections, 4 weeks apart, during the optional open-label extension.

Also known as: naltrexone for extended-release injectable suspension, Medisorb® naltrexone
VIVITROL 380 mg
PlaceboDRUG

Placebo matching VIVITROL 380 mg was administered by IM injection once during the double-blind phase, only.

Placebo

Eligibility Criteria

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

You may qualify if:

  • Current diagnosis of alcohol dependence, meeting at least 3 criteria from the Diagnostic and Statistical Manual of Mental Disorders, 4th Ed. (DSM-IV)
  • Recently completed alcohol detoxification and seeking treatment for alcohol dependence
  • Women of childbearing potential must agree to use an approved method of contraception for study duration

You may not qualify if:

  • Pregnancy or lactation
  • Evidence of hepatic failure including: ascites, bilirubin \>10% above upper limit of normal (ULN) and/or esophageal variceal disease
  • Current dependence (within the past year) to benzodiazepines or cocaine, or current or history of opioid dependence according to DSM-IV criteria
  • Use of any opioids and/or methadone within 14 days prior to the screening visit, or likely to require opioid therapy during the study period
  • Previous enrollment in a VIVITROL clinical trial or previous VIVITROL experience
  • Known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or polylactide-co-glycolide (PLG)
  • Parole, probation, or pending legal proceedings having the potential for incarceration during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Related Publications (1)

  • Lukas SE, Lowen SB, Lindsey KP, Conn N, Tartarini W, Rodolico J, Mallya G, Palmer C, Penetar DM. Extended-release naltrexone (XR-NTX) attenuates brain responses to alcohol cues in alcohol-dependent volunteers: a bold FMRI study. Neuroimage. 2013 Sep;78:176-85. doi: 10.1016/j.neuroimage.2013.03.055. Epub 2013 Apr 6.

    PMID: 23571420RESULT

MeSH Terms

Conditions

AlcoholismBehavior, Addictive

Interventions

vivitrolNaltrexone

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersCompulsive BehaviorImpulsive BehaviorBehavior

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

The study was powered to detect whether VIVITROL blocks the fMRI BOLD signal increase in response to alcohol-related cues as compared to placebo. Results of the secondary endpoints should be interpreted with caution.

Results Point of Contact

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

Study Officials

  • Scott E. Lukas, PhD

    Mclean Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2007

First Posted

August 6, 2007

Study Start

July 1, 2007

Primary Completion

June 1, 2009

Study Completion

October 1, 2009

Last Updated

July 11, 2017

Results First Posted

December 7, 2010

Record last verified: 2017-06

Locations

US(1)