Alcohol DependenceCASPANCT02087358
Alcohol Consumption and Stress at Patients Alcohol-dependants
An observational study of Alcohol Dependence, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This 3 weeks study examines the correlation between stress and alcohol using an ecological, prospective design. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Dependence
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2014to Dec 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study includes alcohol dependent inpatients participating in a 3 weeks detoxification program.
Who may be able to join
- 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
Who cannot join
- Participants without social care insurance
- Any DSM Axis I disorder not defined in the inclusion criteria
- Mandatory psychiatric treatment
Trial locations and contacts
1 site in 1 country.
About this study
This 3 weeks study examines the correlation between stress and alcohol using an ecological, prospective design.
Read the 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.
- Conditions
- Alcohol Dependence
- Keywords
- alcohol dependence, Stress- correlation, genetic, CRHR1
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress level
correlation between stress and alcohol related craving using a prospective ecological design
Measured: 3 weeks follow-up
Secondary outcomes (1)
Genetic association with stress level
Correlation between stress and alcohol related craving using a prospective ecological design stratified for CRHR1 variant
Measured: 3 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2017
- Study completionDec 2017
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.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yann Le Strat, Pr MD, Principal investigator, Psychiatrist Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087358
- Sponsor's protocol ID
- P110908
- Acronym
- CASPA
- Status last verified
- Sep 2018
- First submitted
- 24 Feb 2014
- Last updated
- 25 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol Consumption and Stress at Patients Alcohol-dependants
- ClinicalTrials.gov ID
- NCT02087358
- Acronym / sponsor ID
- CASPA / P110908
- Conditions
- Alcohol Dependence
- Keywords
- alcohol dependence, Stress- correlation, genetic, CRHR1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jul 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 14 Mar 2014 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study includes alcohol dependent inpatients participating in a 3 weeks detoxification program.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Participants without social care insurance
- Any DSM Axis I disorder not defined in the inclusion criteria
- Mandatory psychiatric treatment
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
Stress level
Time frame: 3 weeks follow-up
correlation between stress and alcohol related craving using a prospective ecological design
1 secondary outcome
Genetic association with stress level
Time frame: 3 weeks follow-up
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 Sep 2018.
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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.
Yann Le Strat, Pr MD principal investigator
Psychiatrist Service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Dependence, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 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 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Stress level (time frame: 3 weeks follow-up). 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 Sep 2018.