The Effects of Treatment With Naltrexone in Alcohol and Cannabis-dependent Patients

This study is not yet open for participant recruitment.
Verified March 2012 by Tel-Aviv Sourasky Medical Center
Sponsor:
Collaborator:
Ministry of Health, Israel
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01560013
First received: June 3, 2010
Last updated: March 20, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Alcohol-dependence
Drug: Naltrexone

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 24
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)
Arms Assigned Interventions
Experimental: Naltrexone
Treatment with naltrexone for two months together with psycho-social support
Drug: Naltrexone
Naltrexone, oral 50 mg per day.
Other Name: Revia

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   22 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Alcohol dependent patients both males and females age 22-64

Exclusion Criteria:

  • subjects who are diagnosed as suffering from psychotic illness according to DSM-IV (Axis 1) (American Psychiatric Association, 1994) or with a history of CNS disease, a history of infection that might affect CNS (HIV, syphilis, cytomegalovirus, herpes), a history of head injury with loss of consciousness, history of other substance abuse taking psychoactive medications (shown by urine test). Abnormal liver test results (150% above average) will be excluded. Pregnancy is also an exclusion criterion, as radiation exposure is risky for the fetus.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01560013

Contacts
Contact: Aviv M Weinstein, Ph.D 97236973536 avivweinstein@yahoo.com
Contact: Einat Even-Sapir, MD Ph.D 97236973536 evensap@tasmc.health.gov.il

Locations
Israel
Dept. of Nuclear Medicine, TASMC Not yet recruiting
Tel Aviv, Israel, 64239
Contact: Aviv M Weinstein, Ph.D    97236973536    avivweinstein@yahoo.com   
Contact: Einat Even-Sapir, MD Ph.D    97236973536    evensap@tasmc.health.gov.il   
Principal Investigator: Aviv M Weinstein, Ph.D         
Principal Investigator: Einat Even-Sapir, MD Ph.D         
Sub-Investigator: Isachar Herman, MD         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Ministry of Health, Israel
Investigators
Principal Investigator: Aviv M Weinstein TASMC Israel
  More Information

No publications provided

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01560013     History of Changes
Other Study ID Numbers: 112-10-TLV
Study First Received: June 3, 2010
Last Updated: March 20, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
Alcohol
naltrexone
cue reactivity
PET

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014