Alcohol DependencePhase 4NCT00511836
ALK21-018: Effects of Medisorb® Naltrexone (VIVITROL®) on Alcohol Craving in Treatment-seeking, Alcohol-dependent Adults
A Phase 4 study testing VIVITROL 380 mg in people with Alcohol Dependence, run by Alkermes, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Dependence
- What is being tested?
- VIVITROL 380 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Oct 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Alcohol Dependence
- Being tested
- VIVITROL 380 mg, Placebo
- Keywords
- alcoholism, addiction, alcohol detoxification
- Medical subject headings
- Alcoholism, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIVITROL 380 mgDrug
Also called naltrexone for extended-release injectable suspension, Medisorb® naltrexone
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.
PlaceboDrug
Placebo matching VIVITROL 380 mg was administered by IM injection once during the double-blind phase, only.
| Study group | Role | What they receive |
|---|---|---|
| VIVITROL 380 mg | Experimental | Not described Receives: Drug: VIVITROL 380 mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days (Baseline to Day 14)
Change From Baseline in BOLD Signal Activation Values for the Inferior Frontal Gyrus
Measured: 14 days (Baseline to Day 14)
Change From Baseline in BOLD Signal Activation Values in the Reward Circuitry
Measured: 14 days (Baseline to Day 14)
Secondary outcomes (2)
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.
Measured: 28 days (Baseline to Day 28)
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.
Measured: 28 days (Baseline to Day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionJun 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alkermes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott E. Lukas, PhD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00511836
- Sponsor's protocol ID
- ALK21-018
- Status last verified
- Jun 2017
- First submitted
- 2 Aug 2007
- Last updated
- 11 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 23571420
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00511836
- Acronym / sponsor ID
- ALK21-018
- Conditions
- Alcohol Dependence
- Keywords
- alcoholism, addiction, alcohol detoxification
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 6 Aug 2007 (estimated)
- Results
- Posted 7 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VIVITROL 380 mg | Experimental | Drug: VIVITROL 380 mg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIVITROL 380 mgAlso: naltrexone for extended-release injectable suspension, Medisorb® naltrexoneAdministered via intramuscular (IM) injection once during the double-blind phase and for 2 additional injections, 4 weeks apart, during the optional open-label extension. | Drug | VIVITROL 380 mg |
| PlaceboPlacebo matching VIVITROL 380 mg was administered by IM injection once during the double-blind phase, only. | Drug | Placebo |
Primary outcome
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)
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)
Change From Baseline in BOLD Signal Activation Values in the Reward Circuitry
Time frame: 14 days (Baseline to Day 14)
2 secondary outcomes
Change From Baseline in Obsessive-Compulsive Drinking Scale (OCDS) Score in Alcohol-dependent Subjects
Time frame: 28 days (Baseline to Day 28)
Change From Baseline in Daily Craving Score in Alcohol-dependent Subjects (Actiwatch Data)
Time frame: 28 days (Baseline to Day 28)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23571420Lukas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott E. Lukas, PhD principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing VIVITROL 380 mg in people with Alcohol Dependence, run by Alkermes, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00511836, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.