AlcoholismDIAMANCT02242955
Impact of a One-month Long Detoxification Diazepam Treatment on Early Alcohol Relapse
A study testing Diazepam in people with Alcoholism, run by University Hospital, Lille at 2 sites in France.
Trial summary
Alcohol-dependence is a medical condition that can lead to the occurrence of an alcohol withdrawal syndrome (AWS) in case of alcohol drinking cessation. Diazepam is the reference medication for preventing or treating AWS. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Alcoholism
- What is being tested?
- Diazepam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesFrance
- Study dates
- Jul 2014to Jul 2016
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- DSM-IV-Tr criteria for alcohol dependence
- Diazepam-based outpatient detoxification procedure started 5 days prior to inclusion
Who cannot join
- contraindication for outpatient detoxification
- occurrence of delirium tremens or seizures during the pre-inclusion period
- contraindication for using diazepam
- any other DSM-IV-TR criteria for substance abuse or dependence in the preceding year (except from tobacco)
- concurrent axis-I psychiatric disorder
- concurrent neurological pathology or cognitive impairment
- concurrent social risk, i.e., homelessness or social isolation
- liver failure, cancer, or significant breathing disorder
Trial locations and contacts
2 sites in 1 country.
France2 sites
Department of Addiction Medicine
Lille, 59037
Outpatient Addiction Center "CSAPA - Le Pari"
Lille, 59037
About this study
Alcohol-dependence is a medical condition that can lead to the occurrence of an alcohol withdrawal syndrome (AWS) in case of alcohol drinking cessation. Diazepam is the reference medication for preventing or treating AWS. The recommended average diazepam treatment duration is usually around one week, and this duration is generally not considered to impact the subsequent relapse rate in alcohol drinking.
However, several previous studies have found that patients experienced frequent anxious symptoms during the weeks following detoxification. Such symptoms may foster early relapse in alcohol drinking. Furthermore, it has been suggested that this anxiety could pertain to late withdrawal symptoms.
The DIAMA study hypothesizes that extending the diazepam detoxification treatment to one month can significantly reduce the cumulated relapse rate in alcohol drinking over the three following months.
Read the detailed description
- inclusion at Day 5 of the outpatient alcohol detoxification procedure
- randomization in two arms: 1) "10 day - diazepam"; and 2) "30 day - diazepam"
- tapering of diazepam over the 10 days following the beginning of the detoxification procedure in the first arm; tapering of diazepam over the 30 days following the beginning of the detoxification procedure in the second arm.
- 3-month-long follow-up after detoxification. Objective of maintaining abstinence from alcohol. No use of additional anticraving drug. Standardised psychotherapeutic support based on the BRENDA model.
- Longitudinal recording of alcohol consumption using the Alcohol Timeline Follow-Back method.
- Assessment of craving (Obsessive-Compulsive Drinking Scale) and anxiety (State-Trait Anxiety Inventory; Hamilton Anxiety Rating Scale) at Days 5 (baseline), 15, 30, 60 and 90 (final assessment).
- Conditions
- Alcoholism
- Being tested
- Diazepam
- Keywords
- Alcohol-dependence, Relapse, Detoxification, Diazepam, Benzodiazepines, Anxiety
- Medical subject headings
- Alcoholism, Recurrence, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiazepamDrug
40 mg per day.
| Study group | Role | What they receive |
|---|---|---|
| AD = "as-usual diazepam" | Active comparator | Diazepam treatment duration will not exceed 10 days (commonly recommended duration for alcohol detoxification). Receives: Drug: Diazepam |
| PD = "prolonged diazepam" | Experimental | Diazepam will be slowly tapered to be stopped at day 30 Receives: Drug: Diazepam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of relapse in alcohol drinking
Proportion of patients who will have reported any alcohol drinking over the three months following the beginning of the detoxification procedure (using the alcohol timeline follow-back method).
Measured: at 3 months
Secondary outcomes (7)
Occurrence of adverse events
Measured: Over the first month, at 3 months
Rate of relapse in heavy drinking
Proportion of patients who will have reported at least one heavy drinking day, i.e., ≥ 50 g of alcohol in a day, over the first month and the three month following the beginning of the detoxification procedure (using the alcohol timeline follow-back method).
Measured: at 1 month; at 3 months
Ratio of drinking days/heavy drinking days
Measured: over the first month, at 3 months
Level of self-reported anxiety
Score of self-reported anxiety using the State-Trait Anxiety Inventory
Measured: at 1 month; at 3 months
Level of clinician-assessed anxiety
Score of anxiety using the Hamilton Anxiety Rating Scale
Measured: at 1 month; at 3 months
Level of alcohol craving
Level of alcohol craving using the Obsessive-Compulsive Drinking Scale
Measured: at 1 month; at 3 months
Average weekly alcohol consumption
Measured: at 1 month; at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin ROLLAND, MD, PhD, Principal investigator, University Hospital of Lille (CHU Lille), France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02242955
- Sponsor's protocol ID
- 2011_44
- Other IDs
- 2012-003336-23
- Acronym
- DIAMA
- Status last verified
- Sep 2016
- First submitted
- 15 Sep 2014
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Simioni N, Labreuche J, Behal H, Cottencin O, Rolland B. Thirty- Versus Ten-Day Diazepam Treatment for Alcohol Detoxification and a Comparison of Drinking Patterns, Craving, and Anxiety for up to 12 Weeks: A "Proof-of-Concept" Open-Label Randomized Controlled Trial. J Clin Psychopharmacol. 2017 Dec;37(6):722-728. doi: 10.1097/JCP.0000000000000786.
PubMed 28984747
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a One-month Long Detoxification Diazepam Treatment on Early Alcohol Relapse
- ClinicalTrials.gov ID
- NCT02242955
- Acronym / sponsor ID
- DIAMA / 2011_44
- Conditions
- Alcoholism
- Keywords
- Alcohol-dependence, Relapse, Detoxification, Diazepam, Benzodiazepines, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 17 Sep 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.
Alcohol-dependence is a medical condition that can lead to the occurrence of an alcohol withdrawal syndrome (AWS) in case of alcohol drinking cessation. Diazepam is the reference medication for preventing or treating AWS. The recommended average diazepam treatment duration is usually around one week, and this duration is generally not considered to impact the subsequent relapse rate in alcohol drinking.
However, several previous studies have found that patients experienced frequent anxious symptoms during the weeks following detoxification. Such symptoms may foster early relapse in alcohol drinking. Furthermore, it has been suggested that this anxiety could pertain to late withdrawal symptoms.
The DIAMA study hypothesizes that extending the diazepam detoxification treatment to one month can significantly reduce the cumulated relapse rate in alcohol drinking over the three following months.
Detailed description
- inclusion at Day 5 of the outpatient alcohol detoxification procedure
- randomization in two arms: 1) "10 day - diazepam"; and 2) "30 day - diazepam"
- tapering of diazepam over the 10 days following the beginning of the detoxification procedure in the first arm; tapering of diazepam over the 30 days following the beginning of the detoxification procedure in the second arm.
- 3-month-long follow-up after detoxification. Objective of maintaining abstinence from alcohol. No use of additional anticraving drug. Standardised psychotherapeutic support based on the BRENDA model.
- Longitudinal recording of alcohol consumption using the Alcohol Timeline Follow-Back method.
- Assessment of craving (Obsessive-Compulsive Drinking Scale) and anxiety (State-Trait Anxiety Inventory; Hamilton Anxiety Rating Scale) at Days 5 (baseline), 15, 30, 60 and 90 (final assessment).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AD = "as-usual diazepam" | Active comparator | Drug: DiazepamDiazepam treatment duration will not exceed 10 days (commonly recommended duration for alcohol detoxification). |
| PD = "prolonged diazepam" | Experimental | Drug: DiazepamDiazepam will be slowly tapered to be stopped at day 30 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- DSM-IV-Tr criteria for alcohol dependence
- Diazepam-based outpatient detoxification procedure started 5 days prior to inclusion
Key exclusion criteria (8 listed)
- contraindication for outpatient detoxification
- occurrence of delirium tremens or seizures during the pre-inclusion period
- contraindication for using diazepam
- any other DSM-IV-TR criteria for substance abuse or dependence in the preceding year (except from tobacco)
- concurrent axis-I psychiatric disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diazepam40 mg per day. | Drug | AD = "as-usual diazepam", PD = "prolonged diazepam" |
Primary outcome
Rate of relapse in alcohol drinking
Time frame: at 3 months
Proportion of patients who will have reported any alcohol drinking over the three months following the beginning of the detoxification procedure (using the alcohol timeline follow-back method).
7 secondary outcomes
Occurrence of adverse events
Time frame: Over the first month, at 3 months
Rate of relapse in heavy drinking
Time frame: at 1 month; at 3 months
Ratio of drinking days/heavy drinking days
Time frame: over the first month, at 3 months
Level of self-reported anxiety
Time frame: at 1 month; at 3 months
Level of clinician-assessed anxiety
Time frame: at 1 month; at 3 months
Level of alcohol craving
Time frame: at 1 month; at 3 months
Average weekly alcohol consumption
Time frame: at 1 month; at 3 months
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 22 Apr 2026.
- Results publication: PubMed 28984747Simioni N, Labreuche J, Behal H, Cottencin O, Rolland B. Thirty- Versus Ten-Day Diazepam Treatment for Alcohol Detoxification and a Comparison of Drinking Patterns, Craving, and Anxiety for up to 12 Weeks: A "Proof-of-Concept" Open-Label Randomized Controlled Trial. J Clin Psychopharmacol. 2017 Dec;37(6):722-728. doi: 10.1097/JCP.0000000000000786.
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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.
Benjamin ROLLAND, MD, PhD principal investigator
University Hospital of Lille (CHU Lille), France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diazepam in people with Alcoholism, run by University Hospital, Lille at 2 sites 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 2 inclusion and 8 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 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Rate of relapse in alcohol drinking (time frame: at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02242955, which also lists 1 linked publication.
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 22 Apr 2026.