The importance of one initial month of abstinence in the treatment of alcohol dependence with a goal of controlled drinking: effects on alcohol consumption and health at short- and long-term follow-up
| ISRCTN | ISRCTN14315625 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14315625 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Beroendecentrum Stockholm |
| Funders | ALF medicin, Vetenskapsrådet |
- Submission date
- 31/03/2023
- Registration date
- 27/06/2023
- Last edited
- 05/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Many patients with alcohol problems wish to reduce their drinking without abstaining totally. It is unclear whether it would be beneficial for these patients to start treatment with a month of abstinence. The aim of this study is to test whether a month of abstinence before treatment with an aim of controlled drinking results in better treatment outcomes.
Who can participate?
Patients aged over 18 years with alcohol dependence seeking treatment with a goal of controlled drinking
What does the study involve?
Participants are randomly allocated to 1 month of initial abstinence or to treatment as usual without such initial abstinence. All participants have a treatment goal of controlled drinking. They are offered the same treatment options: cognitive behavioural therapy (CBT) combined with pharmacological treatment.
What are the possible benefits and risks of participating?
One month of sobriety may be beneficial for health. Both treatments are likely to reduce alcohol consumption. The risks of participating are small as participants are alcohol-dependent with long-standing heavy drinking.
There is now good evidence that treatment aiming for controlled drinking, as opposed to abstinence, has good effects for persons with mild to moderate dependence severity, while persons with severe dependence are recommended abstinence. There are however several good reasons to abstain from alcohol for a period for this group as well. There is evidence that a month of sobriety is beneficial for mental, cardiovascular and metabolic health, after 1 and 6 months of follow-up. These studies however have been performed with moderate drinkers, where dependence has been an exclusion criterion. What the outcomes are for alcohol-dependent persons with higher levels of consumption has not been investigated. Even when the treatment aim is controlled drinking, an initial month of abstinence is frequently recommended. The assumption here is that the toxic effects of alcohol, which often manifest in high levels of craving, are reduced after a month of sobriety, and that this improves the prerequisites for the following treatment. This seems reasonable for persons with long-standing heavy drinking. Whether it also applies for the larger group with mild to moderate dependence has not been studied however.
Where is the study run from?
Stockholm Centre for Dependency Disorders (Sweden)
When is the study starting and how long is it expected to run for?
January 2021 to December 2025
Who is funding the study?
1. ALF medicin (Sweden)
2. Swedish Research Council (Sweden)
Who is the main contact?
Dr Sven Andréasson, sven.andreasson@ki.se
Contact information
Principal investigator
Mottagningen för alkohol och hälsa
Riddargatan 1
Stockholm
11435
Sweden
 ORCID ID |
0000-0003-0258-5762 |
|---|---|
| Phone | +46 (0)708625946 |
| sven.andreasson@ki.se |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled trial between-groups design |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | The importance of one initial month of abstinence in the treatment of alcohol dependence with a goal of controlled drinking: effects on alcohol consumption and health at short and long term follow-up |
| Study acronym | VM (Vit Månad - "white month") |
| Study objectives | This study will test the hypothesis that 1 month of abstinence will improve treatment outcomes for patients with a goal of controlled drinking. |
| Ethics approval(s) | Approved 27/05/2021, The Swedish Ethical Review Authority (Etikprövningsmyndigheten, Box 2110, 75002 Uppsala, Sweden; +46 (0)10 475 08 00; registrator@etikprovning.se), ref: 2021-01959 |
| Health condition(s) or problem(s) studied | Alcohol dependence |
| Intervention | All study participants have a treatment goal of controlled drinking. They are offered the same treatment options: cognitive behavioural therapy (CBT) combined with pharmacological treatment. In addition to this, they will be randomized to either start their treatment with 1 month of abstinence or start with controlled drinking treatment right away. Randomisation is done through computer-generated randomization in blocks of 10; allocation 1:1. Randomisation is performed for each inclusion, where the study participant is given a study ID which conforms to the number of inclusion. The allocation is unknown to the study coordinator and other study staff up until the point of study inclusion and the start of treatment. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Alcohol consumption measured by the Timeline Follow Back method, where drinks per week can be calculated, at baseline, 1, 6 and 12 months |
| Key secondary outcome measure(s) |
Heavy drinking days measured by the Timeline Follow Back method, where the number of days per week with heavy drinking, defined as 5 or more Swedish standard drinks for men and 4 or more for women can be calculated, at baseline, 1, 6 and 12 months |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 200 |
| Key inclusion criteria | 1. Alcohol dependence according to ICD-10 criteria 2. Male and female >18 years of age 3. Housing in Stockholm county |
| Key exclusion criteria | 1. Severe mental illness 2. Abuse or dependence of other substances apart from alcohol and/or nicotine 3. Severe somatic illness 4. Non-Swedish speaking |
| Date of first enrolment | 01/04/2023 |
| Date of final enrolment | 28/02/2025 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Stockholm
11435
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Sven Andreasson (sven.andreasson@ki.se). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
05/02/2025: The overall end date was changed from 25/08/2031 to 31/12/2025.
24/01/2025: The recruitment end date was changed from 31/01/2025 to 28/02/2025.
27/12/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 31/03/2024 to 31/01/2025.
2. The overall study end date was changed from 31/12/2024 to 25/08/2031.
3. The intention to publish date was changed from 01/06/2025 to 25/12/2031.
4. The target number of participants was changed from 320 to 200.
03/04/2023: Trial's existence confirmed by the Swedish Ethical Review Authority.
