Phase 4
Completed N=31
ALK21-018: Effects of Medisorb® Naltrexone (VIVITROL®) on Alcohol Craving in Treatment-seeking, Alcohol-dependent Adults
Source: ClinicalTrials.gov NCT00511836 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Dec 2010
Primary outcomePrimary: 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. — 0.041; -0.044 Percentage (%) of Change — p=<0.00002
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
0.041; -0.044 | <0.00002 sig |
| PRIMARY Change From Baseline in BOLD Signal Activation Values for the Inferior Frontal Gyrus |
0.001; -0.067 | <0.013 sig |
| PRIMARY Change From Baseline in BOLD Signal Activation Values in the Reward Circuitry |
-0.018; -0.060 | 0.245 |
| SECONDARY Change From Baseline in Obsessive-Compulsive Drinking Scale (OCDS) Score in Alcohol-dependent Subjects |
-8.5; -7.3 | — |
| SECONDARY Change From Baseline in Daily Craving Score in Alcohol-dependent Subjects (Actiwatch Data) |
-0.846; -0.789 | — |
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
Data sourced from ClinicalTrials.gov (NCT00511836). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.