ALK21-018: Effects of Medisorb® Naltrexone (VIVITROL®) on Alcohol Craving in Treatment-seeking, Alcohol-dependent Adults

This study has been completed.
Sponsor:
Information provided by:
Alkermes, Inc.
ClinicalTrials.gov Identifier:
NCT00511836
First received: August 2, 2007
Last updated: December 9, 2010
Last verified: December 2010
  Purpose

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.


Condition Intervention Phase
Alcohol Dependence
Drug: VIVITROL 380 mg
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of VIVITROL® on Alcohol-Related Cue-Induced Craving and BOLD [Blood Oxygen-level-dependent] Functional Magnetic Resolution Imaging (fMRI) Signal Activation Patterns

Resource links provided by NLM:


Further study details as provided by Alkermes, Inc.:

Primary Outcome Measures:
  • 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. [ Time Frame: 14 days (Baseline to Day 14) ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in BOLD Signal Activation Values for the Inferior Frontal Gyrus [ Time Frame: 14 days (Baseline to Day 14) ] [ Designated as safety issue: No ]
  • Change From Baseline in BOLD Signal Activation Values in the Reward Circuitry [ Time Frame: 14 days (Baseline to Day 14) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change From Baseline in Obsessive-Compulsive Drinking Scale (OCDS) Score in Alcohol-dependent Subjects [ Time Frame: 28 days (Baseline to Day 28) ] [ Designated as safety issue: No ]
    There are 14 items on the Obsessive Compulsive Drinking Scale (OCDS). The scale is scored from 0 to 40 (units). A score of 0 units indicates no obsession-compulsion with respect to alcohol (best score). A score of 40 units indicates maximum obsession-compulsion with respect to alcohol (worst score). A negative Change from Baseline value indicates an improvement. For scoring methods, see: Anton RF, Moak DH, Latham P (1995), The Obsessive Compulsive Drinking Scale: A self-rated instrument for the quantification of thoughts about alcohol and drinking behavior. Alcohol Clin Exp Res 19:92-9.

  • Change From Baseline in Daily Craving Score in Alcohol-dependent Subjects (Actiwatch Data) [ Time Frame: 28 days (Baseline to Day 28) ] [ Designated as safety issue: No ]
    The Actiwatch-Score device (MiniMitter Co.) was used to collect data on daily alcohol craving. The Actiwatch device is a wrist-worn, battery-operated monitor programmed to beep every 3 hours ±20 minutes, to signal the subjects to enter their alcohol craving or desire to use alcohol at that exact moment on a scale of 0 to 10 units: 0 indicates no craving at all (best score) and 10 indicates extreme craving (worst score). A negative result for Change in Baseline at Day 28 indicates an improvement in daily craving as of 1 month after study drug administration.


Enrollment: 31
Study Start Date: July 2007
Study Completion Date: October 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VIVITROL 380 mg Drug: VIVITROL 380 mg
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.
Other Names:
  • naltrexone for extended-release injectable suspension
  • Medisorb® naltrexone
Placebo Comparator: Placebo Drug: Placebo
Placebo matching VIVITROL 380 mg was administered by IM injection once during the double-blind phase, only.

Detailed Description:

The double-blind phase consisted of 6 visits over a 5- to 6-week period and included 2 telephone contacts and 2 functional magnetic resonance imaging (fMRI) scans.

The optional open-label extension included 2 visits approximately 1 month apart. Subjects who completed both phases participated in a total of 8 scheduled visits (including 2 fMRI scans and 2 telephone contacts) over a period of up to 14 weeks.

At screening, eligible, consenting subjects were given an Actiwatch®-Score device. They were instructed to record their alcohol craving using this device throughout the double-blind phase. The Actiwatch was programmed to beep every 3 hours ±20 minutes, thereby signaling the subjects to enter their craving or desire to use alcohol, at that exact moment, on a scale of 0 to 10 (with 0 being no craving at all and 10 being extreme craving). In addition, subjects entered any drug and/or alcohol use at the time of occurrence. The Actiwatch was not utilized in the open-label portion of the study.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Primary Inclusion Criteria:

  • 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

Primary Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00511836

Locations
United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Alkermes, Inc.
Investigators
Principal Investigator: Scott E. Lukas, PhD Mclean Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Scott E. Lukas, PhD, McLean Hospital
ClinicalTrials.gov Identifier: NCT00511836     History of Changes
Other Study ID Numbers: ALK21-018
Study First Received: August 2, 2007
Results First Received: June 10, 2010
Last Updated: December 9, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Alkermes, Inc.:
alcoholism
addiction
alcohol detoxification

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Naltrexone
Central Nervous System Agents
Narcotic Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014