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

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

VIVITROL 380 mg

Placebo

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring alcoholism, addiction, alcohol detoxification

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

McLean Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

VIVITROL 380 mg

Placebo

Arm Description

Outcomes

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.

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

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

Secondary Outcome Measures

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

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)

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.

Full Information

NCT ID

NCT00511836

First Posted

August 2, 2007

Last Updated

June 8, 2017

Sponsor

Alkermes, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00511836

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

July 2007 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alkermes, Inc.

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

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.

6. Conditions and Keywords

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

Alcohol Dependence

Keywords

alcoholism, addiction, alcohol detoxification

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

VIVITROL 380 mg

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

VIVITROL 380 mg

Other Intervention Name(s)

naltrexone for extended-release injectable suspension, Medisorb® naltrexone

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

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.

Description

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.

Time Frame

14 days (Baseline to Day 14)

Title

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

Time Frame

14 days (Baseline to Day 14)

Title

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

Time Frame

14 days (Baseline to Day 14)

Secondary Outcome Measure Information:

Title

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

Description

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.

Time Frame

28 days (Baseline to Day 28)

Title

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

Description

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.

Time Frame

28 days (Baseline to Day 28)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Scott E. Lukas, PhD

Organizational Affiliation

Mclean Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

McLean Hospital

City

Belmont

State/Province

Massachusetts

ZIP/Postal Code

02478

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

23571420

Citation

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.

Results Reference

result

Links:

URL

http://www.psych.org/Departments/EDU/Library/APAOfficialDocumentsandRelated/Conference-Publications/Annual-Meeting-New-Research-Abstracts/2010.aspx

Description

American Psychiatric Association - 2010 Annual Meeting - New Research Abstract # NR1-49

Alcohol Dependence

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial