Alcohol Consumption and Stress at Patients Alcohol-depend... | NCT02087358

Studies
Alcohol Consumption and Stress at Patients Alcohol-dependants

NCT02087358

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Sep 25, 2018Actual

Enrollment

42Actual

Phase

Not provided

Conditions

Alcohol Dependence

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2014

Primary Completion Date

Jul 2017Actual

Completion Date

Dec 2017Actual

First Submitted Date

Feb 24, 2014

First Submission Date that Met QC Criteria

Mar 12, 2014

First Posted Date

Mar 14, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 24, 2018

Last Update Posted Date

Sep 25, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This 3 weeks study examines the correlation between stress and alcohol using an ecological, prospective design.

Detailed Description

This 3 weeks study examines the correlation between stress and alcohol using an ecological, prospective design. Participants will be given phone calls 4 times a day for 3 weeks, assessing perceived stress and alcohol related craving.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stress and craving		This 3 weeks study examines the correlation between stress and alcohol using an ecological, prospective design. Participants will be given phone calls 4 times a day for 3 weeks, assessing perceived stress and alcohol related craving.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stress level	correlation between stress and alcohol related craving using a prospective ecological design	3 weeks follow-up

Secondary Outcomes

Measure	Description	Time Frame
Genetic association with stress level	Correlation between stress and alcohol related craving using a prospective ecological design stratified for CRHR1 variant	3 weeks follow-up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Males or Females aged 18-65 years
Alcohol use disorder defined by DSM 5 criteria
Fluent in French
Hospitalized for alcohol withdrawal for at least 7 days
Viable (working) telephone number

Exclusion criteria:

Participants without social care insurance
Any DSM Axis I disorder not defined in the inclusion criteria
Mandatory psychiatric treatment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

This study includes alcohol dependent inpatients participating in a 3 weeks detoxification program.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yann Le Strat, Pr MD	Psychiatrist Service	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Louis Mourier, Service de psychiatrie		Colombes		92701	France

Condition Browse Module

MeSH Terms

ID	Term
D000437	Alcoholism

Ancestor Terms

ID	Term
D019973	Alcohol-Related Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided