- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01991704
Incubation of Alcohol Craving During Abstinence
November 18, 2013 updated by: National Institute on Drug Dependence, China
The Neural Mechanisms of the Incubation of Cue-induced Craving in Alcohol Dependence
In order to determine whether the 'incubation of craving' phenomenon also occurred in alcoholics, investigators employed an experimental approach to investigate the time course of cue-induced craving in alcoholism.
Eighty male participants were randomly divided into Four groups, and they were assessed at 7, 14, 30, and 60 days of abstinence for cue-induced alcohol craving .
Another group including 19 patients was repeatedly tested for the cue-induced alcohol craving at the above abstinence days.
Other psychological and physiological measures were administered at the four abstinence time points.
Study Overview
Status
Completed
Conditions
Detailed Description
All subjects provided written informed consent after a full explanation of the protocol design.
Study Type
Observational
Enrollment (Actual)
99
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Probability Sample
Study Population
alcohol dependence
Description
Inclusion Criteria:
- met the criteria of DSM-IV for alcohol dependence
- aged 18-60 years,male
Exclusion Criteria:
- current or past history of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) axis I disorders
- with other serious physical diseases (respiratory disorders, cardiovascular disease and so on)
- other drug abuse except for nicotine
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
changes of alcohol craving measured with visual analogue scales
Time Frame: abstained from alcohol for 7 days, 14 days, 30 days and 60 days
|
abstained from alcohol for 7 days, 14 days, 30 days and 60 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
heart rate changes
Time Frame: 7, 14, 30 and 60 days after abstained
|
7, 14, 30 and 60 days after abstained
|
blood pressure changes in different abstinence days
Time Frame: 7, 14, 30 and 60 days after abstained
|
7, 14, 30 and 60 days after abstained
|
skin conductance changes in different abstinence days
Time Frame: 7, 14, 30 and 60 days after abstained
|
7, 14, 30 and 60 days after abstained
|
changes of Alcohol Urge Questionnaire
Time Frame: 7, 14, 30 and 60 days after abstained
|
7, 14, 30 and 60 days after abstained
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Lin Lu, Prof., National Institute on Drug Dependence, China
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
October 1, 2013
Study Registration Dates
First Submitted
November 8, 2013
First Submitted That Met QC Criteria
November 18, 2013
First Posted (Estimate)
November 25, 2013
Study Record Updates
Last Update Posted (Estimate)
November 25, 2013
Last Update Submitted That Met QC Criteria
November 18, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- nidd_peking
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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