Incubation of Alcohol Craving During Abstinence

Alcohol Dependence Clinical Trial

Official title:

The Neural Mechanisms of the Incubation of Cue-induced Craving in Alcohol Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01991704
• Other study ID #: nidd_peking
• Status: Completed
• Phase: N/A
• First received: November 8, 2013
• Last updated: November 18, 2013
• Start date: October 2011
• Est. completion date: October 2013

Study information

• Verified date: November 2013
• Source: National Institute on Drug Dependence, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Observational

Clinical 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. 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.

Description:

All subjects provided written informed consent after a full explanation of the protocol design.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: October 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National Institute on Drug Dependence, China	National Natural Science Foundation of China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes of alcohol craving measured with visual analogue scales		abstained from alcohol for 7 days, 14 days, 30 days and 60 days	No
Secondary	heart rate changes		7, 14, 30 and 60 days after abstained	No
Secondary	blood pressure changes in different abstinence days		7, 14, 30 and 60 days after abstained	No
Secondary	skin conductance changes in different abstinence days		7, 14, 30 and 60 days after abstained	No
Secondary	changes of Alcohol Urge Questionnaire		7, 14, 30 and 60 days after abstained	No