Alcohol-dependenceNCT01560013
The Effects of Treatment With Naltrexone in Alcohol and Cannabis-dependent Patients
A study testing Naltrexone in people with Alcohol-dependence, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 64 years
- Conditions the study is for
- Alcohol-dependence
- What is being tested?
- Naltrexone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2012to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 22 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Alcohol dependent patients both males and females age 22-64
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Dept. of Nuclear Medicine, TASMC
Tel Aviv, 64239
Aviv M Weinstein, Ph.D, 97236973536, avivweinstein@yahoo.com
Einat Even-Sapir, MD Ph.D, 97236973536, evensap@tasmc.health.gov.il
About this study
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
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.
Read the 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.
- Conditions
- Alcohol-dependence
- Being tested
- Naltrexone
- Keywords
- Alcohol, naltrexone, cue reactivity, PET
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaltrexoneDrug
Also called Revia
Naltrexone, oral 50 mg per day.
| Study group | Role | What they receive |
|---|---|---|
| Naltrexone | Experimental | Treatment with naltrexone for two months together with psycho-social support Receives: Drug: Naltrexone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verified abstinence from alcohol
Patients will be tested for alcohol at the end of treatment after 2 months
Measured: 2 months
Secondary outcomes (1)
Changes in subjective responses to alcohol-cue reactivity and brain's metabolic rates
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.
Measured: At baseline and after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol-dependenceStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- Ministry of Health, Israel
- Responsible party
- Sponsor
- Investigators
- Aviv M Weinstein, Principal investigator, TASMC Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01560013
- Sponsor's protocol ID
- 112-10-TLV
- Status last verified
- Mar 2012
- First submitted
- 3 Jun 2010
- Last updated
- 21 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01560013
- Acronym / sponsor ID
- 112-10-TLV
- Conditions
- Alcohol-dependence
- Keywords
- Alcohol, naltrexone, cue reactivity, PET
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- Ministry of Health, Israel
- Study start
- Oct 2012
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 21 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Naltrexone | Experimental | Drug: NaltrexoneTreatment with naltrexone for two months together with psycho-social support |
Who may qualify
- Ages
- 22 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Alcohol dependent patients both males and females age 22-64
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| NaltrexoneAlso: ReviaNaltrexone, oral 50 mg per day. | Drug | Naltrexone |
Primary outcome
Verified abstinence from alcohol
Time frame: 2 months
Patients will be tested for alcohol at the end of treatment after 2 months
1 secondary outcome
Changes in subjective responses to alcohol-cue reactivity and brain's metabolic rates
Time frame: At baseline and after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2012.
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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.
Aviv M Weinstein principal investigator
TASMC Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Naltrexone in people with Alcohol-dependence, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 21 Mar 2012. 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 Israel. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aviv M Weinstein, Ph.D (97236973536, avivweinstein@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verified abstinence from alcohol (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Mar 2012.