NCT02087358

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2014

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 14, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

September 25, 2018

Status Verified

September 1, 2018

Enrollment Period

3 years

First QC Date

February 24, 2014

Last Update Submit

September 24, 2018

Conditions

Alcohol Dependence

Keywords

alcohol dependenceStress- correlationgeneticCRHR1

Outcome Measures

Primary Outcomes (1)

  • Stress level

    correlation between stress and alcohol related craving using a prospective ecological design

    3 weeks follow-up

Secondary Outcomes (1)

  • Genetic association with stress level

    3 weeks follow-up

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Participants without social care insurance
  • Mandatory psychiatric treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Louis Mourier, Service de psychiatrie

Colombes, 92701, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

CRHR1 gene polymorphisisme

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Yann Le Strat, Pr MD

    Psychiatrist Service

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2014

First Posted

March 14, 2014

Study Start

July 1, 2014

Primary Completion

July 1, 2017

Study Completion

December 1, 2017

Last Updated

September 25, 2018

Record last verified: 2018-09

Locations

FR(1)