The Effects of Treatment With Naltrexone in Alcohol and Cannabis-dependent Patients
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
1 other identifier
interventional
24
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 3, 2010
CompletedFirst Posted
Study publicly available on registry
March 21, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedMarch 21, 2012
March 1, 2012
2 years
June 3, 2010
March 20, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Verified abstinence from alcohol
Patients will be tested for alcohol at the end of treatment after 2 months
2 months
Secondary Outcomes (1)
Changes in subjective responses to alcohol-cue reactivity and brain's metabolic rates
At baseline and after treatment
Study Arms (1)
Naltrexone
EXPERIMENTALTreatment with naltrexone for two months together with psycho-social support
Interventions
Eligibility Criteria
You may qualify if:
- Alcohol dependent patients both males and females age 22-64
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tel-Aviv Sourasky Medical Centerlead
- Ministry of Health, Israelcollaborator
Study Sites (1)
Dept. of Nuclear Medicine, TASMC
Tel Aviv, 64239, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aviv M Weinstein
TASMC Israel
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2010
First Posted
March 21, 2012
Study Start
October 1, 2012
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
March 21, 2012
Record last verified: 2012-03