The Effects of Treatment With Naltrexone in Alcohol and Cannabis-dependent Patients
Alcohol dependence is a major health problem worldwide and recently in Israel and it has major health care costs. Cannabis dependence is also a major health issue and many cannabis users find it difficult to quit. Similar to dependence on heavy drugs, alcohol and cannabis-dependent patients find it difficult to quit drinking and smoking cannabis and they relapse to drinking alcohol and using cannabis during treatment. Craving for alcohol and cannabis and withdrawal during detoxification are major factors for relapse to drinking and using cannabis. The cue-exposure and priming paradigms have been used in order to induce craving for alcohol and cannabis in the laboratory. Several studies have delineated the brain mechanisms responsible for cue-induced craving for alcohol using functional Magnetic Resonance Imaging (fMRI), a method that can be useful in monitoring progress of treatment. A proven useful medication for treatment of alcohol dependence is the opiate antagonist naltrexone commonly used for treatment of opiate dependence. We have found that cannabis-dependent patients in treatment for cannabis dependence who also were heavy users of alcohol have dropped early from treatment.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Brain Imaging Study on the Effects of Treatment With Naltrexone on Cue-induced Craving and Brain's Metabolic Changes in Alcohol and Cannabis-dependent Patients|
- Verified abstinence from alcohol [ Time Frame: 2 months ] [ Designated as safety issue: No ]Patients will be tested for alcohol at the end of treatment after 2 months
- Changes in subjective responses to alcohol-cue reactivity and brain's metabolic rates [ Time Frame: At baseline and after treatment ] [ Designated as safety issue: No ]Alcohol and cannabis-dependent patients undergoing treatment with naltrexone will be assessed before and after treatment by the alcohol-cue exposure together with measures of the brain's metabolism using [18F] Fluoro-dioxyglucose (FDG) as the radiotracer in Positron Emission Tomography (PET) and subjective craving responses to the cues.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||October 2014|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Treatment with naltrexone for two months together with psycho-social support
Naltrexone, oral 50 mg per day.
Other Name: Revia
We propose to use naltexone to reduce craving for alcohol and cannabis in alcohol and cannabis-dependent patients. We also propose to use established techniques of priming and cue-exposure for alcoholic drinks and cannabis together with measures of [18F] Fluorodeoxyglucose (FDG) in Positron Emission Tomography (PET) imaging in 24 alcohol and cannabis-dependent patients before and after 35 day treatment with naltrexone. We predict that in those who will be successful in quitting alcohol drinking and using cannabis there would be a reduction in alcohol and cannabis cue-induced brain activity in the meso-limbic reward circuit that is responsible for craving for alcohol and cannabis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01560013
|Contact: Aviv M Weinstein, Ph.Dfirstname.lastname@example.org|
|Contact: Einat Even-Sapir, MD Ph.Demail@example.com|
|Dept. of Nuclear Medicine, TASMC||Not yet recruiting|
|Tel Aviv, Israel, 64239|
|Contact: Aviv M Weinstein, Ph.D 97236973536 firstname.lastname@example.org|
|Contact: Einat Even-Sapir, MD Ph.D 97236973536 email@example.com|
|Principal Investigator: Aviv M Weinstein, Ph.D|
|Principal Investigator: Einat Even-Sapir, MD Ph.D|
|Sub-Investigator: Isachar Herman, MD|
|Principal Investigator:||Aviv M Weinstein||TASMC Israel|