Alcohol DependenceNCT01991704
Incubation of Alcohol Craving During Abstinence
An observational study of Alcohol Dependence, run by National Institute on Drug Dependence, China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Alcohol Dependence
- How many people
- 99 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Oct 2013
- Phase
- Observational
- 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 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Study population: alcohol dependence
Who may be able to join
- met the criteria of DSM-IV for alcohol dependence
- aged 18-60 years,male
Who cannot join
- 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
About this study
Official title: 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.
Read the detailed description
All subjects provided written informed consent after a full explanation of the protocol design.
- Conditions
- Alcohol Dependence
- Keywords
- incubation, Craving, alcohol dependence
- Medical subject headings
- Alcoholism
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of alcohol craving measured with visual analogue scales
Measured: abstained from alcohol for 7 days, 14 days, 30 days and 60 days
Secondary outcomes (4)
heart rate changes
Measured: 7, 14, 30 and 60 days after abstained
blood pressure changes in different abstinence days
Measured: 7, 14, 30 and 60 days after abstained
skin conductance changes in different abstinence days
Measured: 7, 14, 30 and 60 days after abstained
changes of Alcohol Urge Questionnaire
Measured: 7, 14, 30 and 60 days after abstained
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startOct 2011
- Primary completionMar 2013
- Study completionOct 2013
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.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Dependence, China
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Sponsor
- Investigators
- Lin Lu, Prof., Study director, National Institute on Drug Dependence, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01991704
- Sponsor's protocol ID
- nidd_peking
- Status last verified
- Nov 2013
- First submitted
- 8 Nov 2013
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neural Mechanisms of the Incubation of Cue-induced Craving in Alcohol Dependence
- ClinicalTrials.gov ID
- NCT01991704
- Acronym / sponsor ID
- nidd_peking
- Conditions
- Alcohol Dependence
- Keywords
- incubation, Craving, alcohol dependence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- National Institute on Drug Dependence, ChinaUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- Oct 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 25 Nov 2013 (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.
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.
Detailed description
All subjects provided written informed consent after a full explanation of the protocol design.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- alcohol dependence
Key inclusion criteria (2 listed)
- met the criteria of DSM-IV for alcohol dependence
- aged 18-60 years,male
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
changes of alcohol craving measured with visual analogue scales
Time frame: abstained from alcohol for 7 days, 14 days, 30 days and 60 days
4 secondary outcomes
heart rate changes
Time frame: 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
skin conductance changes in different abstinence days
Time frame: 7, 14, 30 and 60 days after abstained
changes of Alcohol Urge Questionnaire
Time frame: 7, 14, 30 and 60 days after abstained
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
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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.
Lin Lu, Prof. study director
National Institute on Drug Dependence, China
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Dependence, run by National Institute on Drug Dependence, China.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes of alcohol craving measured with visual analogue scales (time frame: abstained from alcohol for 7 days, 14 days, 30 days and 60 days). 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 25 Nov 2013.