The importance of an initial sober month of in the treatment of alcohol dependence with a focus on controlled drinking: short- and long-term effects on alcohol consumption and health status
| ISRCTN | ISRCTN47033189 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47033189 |
| Secondary identifying numbers | 2021-01959 |
- Submission date
- 13/11/2024
- Registration date
- 22/11/2024
- Last edited
- 15/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
This study aims to find out if taking a break from drinking alcohol for a month before starting treatment for controlled drinking leads to better health outcomes. While controlled drinking is effective for people with mild to moderate alcohol dependence, those with severe dependence are usually advised to stop drinking completely. A "dry month" has been shown to improve heart, metabolic, and mental health in moderate drinkers, but its effects on people with alcohol dependence are not well known. This study will compare the health and drinking habits of people who take a month off alcohol before treatment to those who do not.
Who can participate?
Adults seeking treatment for alcohol use disorder, who aim to control their drinking, and do not have major psychiatric conditions can participate in this study.
What does the study involve?
Participants will be randomly assigned to one of two groups. One group will receive Cognitive and Behavioral Therapy (CBT) for controlled drinking, including a 30-day period of complete abstinence at the start. The other group will receive the same CBT treatment without the initial abstinence period. Both groups will have five therapy sessions over four months and can choose to receive medication support if desired. Health and drinking habits will be measured at the start, after one month, and after six months.
What are the possible benefits and risks of participating?
Participants may benefit from improved health and better control over their drinking. The study will help determine if a period of abstinence before treatment leads to better outcomes. Risks may include the challenges of abstaining from alcohol and the time commitment required for therapy sessions and assessments.
Where is the study run from?
The study is conducted at the Alcohol and Health Clinic, Riddargatan 1 in Stockholm, Sweden.
When is the study starting and how long is it expected to run for?
October 2020 to December 2027
Who is funding the study?
The study is funded by the Stockholm City Council (ALF Medicin) and the Research Council of the Swedish Alcohol Retailing Monopoly.
Who is the main contact?
Sven Andréasson, PhD, sven.andreasson@ki.se
Contact information
Public, Scientific, Principal Investigator
Mottagningen för alkohol och hälsa
Riddargatan 1
Stockholm
11435
Sweden
 ORCID ID |
0000-0003-0258-5762 |
|---|---|
| Phone | +46 8-12345780 |
| sven.andreasson@ki.se |
Study information
| Study design | Single-centre randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment, Efficacy |
| Participant information sheet | Not available in web format. Please use contact details to request a participant information sheet |
| Scientific title | The importance of an initial month of complete sobriety in the treatment of alcohol use disorder with a focus on controlled drinking: effects on alcohol consumption and health status in short- and long-term follow-up |
| Study objectives | This project hypothesizes that a one-month period of complete sobriety before treatment focused on controlled drinking will lead to better treatment outcomes in both the short and long term, compared to treatment without prior sobriety. Treatment including prior sobriety is expected to reduce alcohol consumption, alcohol cravings,, and reduce severity of the alcohol use disorder. Additionally, it is anticipated that cardiovascular, metabolic, and mental health will improve both in the short term (1 month) and in the longer term (6 months). |
| Ethics approval(s) |
Approved 31/05/2021, Etikprövningsmyndigheten (Swedish Ethical Review Authority) (Box 2110, Uppsala, 750 02, Sweden; +46 10-475 08 00; registrator@etikprovning.se), ref: 2021-01959 |
| Health condition(s) or problem(s) studied | Alocohol use disorder |
| Intervention | Cognitive behavioral treatment for the goal of controlled drinking with an add-on of a sober month including optional pharmacological support compared to cognitive behavioral treatment for the goal of controlled drinking only (treatment as usual). Participants with a treatment goal of controlled drinking were randomised to either begin their treatment with a one month sobriety period before starting CBT treatment or to one month of trying to reduce their drinking without sobriety. Following this first month, both groups received the same treatment program. This was a 12 week CBT program with with four treatment sessions and homework assignments. Patients requesting pharmaceutical treatment were given prescriptions for naltrexone or acamprosate. At 4 weeks there was a follow-up with biochemical markers and questionnaires, and at 24 weeks a concluding follow-up was conducted with biochemical markers and questionnaires. Following this, treatment, as well as research participation, was terminated. Randomisation was performed using an online tool with randomisation in blocks of 10 using a web-based randomisation service. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Mean weekly alcohol consumption (in standard drinks) is measured using a structured interview following the Timeline Follow-Back (TLFB) method at baseline and 6-month follow-up 2. Frequency of binge drinking (4 or more/5 or more, women/men, standard drinks per drinking occasion) in the previous 30-day period is measured using a structured interview following the Timeline Follow-Back (TLFB) method at baseline and 6-month follow-up |
| Secondary outcome measures | 1. Alcohol consumption is measured using Phosphatidylethanol (PEth) at one and six months post inclusion 2. Liver function is measured using analyses of Gamma-glutamyltransferase (GGT), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) at one and six months post inclusion 3. Goal-setting (abstinence or reduced consumption) is measured using a goal-setting questionnaire at one and six months post inclusion 4. Degree of alcohol dependence is measured using a questionnaire for dependence criteria according to ICD-10 and DSM-5 at one and six months post inclusion 5. Degree of alcohol dependence is measured using the Alcohol Use Disorders Identification Test (AUDIT) at one and six months post inclusion 6. Motivation for change and confidence in the ability to change drinking habits is measured using self-assessment on a Visual Analog Scale (VAS) at one and six months post inclusion 7. Heart rate is measured at one and six months post inclusion 8. Blood pressure is measured using an automatic blood pressure monitor after 10 minutes of rest at one and six months post inclusion 9. Lipids (HDL and LDL cholesterol, and triglycerides) are measured using blood samples at one and six months post inclusion 10. Glucose is measured using blood samples at one and six months post inclusion 11. Level of anxiety is measured using GAD-7 at one and six months post inclusion 12. Level of depression is measured using PHQ-9 at one and six months post inclusion |
| Overall study start date | 01/10/2020 |
| Completion date | 31/12/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | 200 |
| Key inclusion criteria | 1. Fulfilment of an alcohol use disorder/Alcohol dependence diagnosis, defined as meeting 2 or more criteria for alcohol use disorder according to the DSM-5, or 3 or more criteria according to ICD-10 2. Alcohol consumption exceeding 10 standard drinks (12 grams of pure ethanol) and/or binge drinking exceeding 4/5 standard drinks (women/men) per occasion, one or more times per month in the 30 days before the assessment day 3. A stated treatment goal of controlled drinking 4. Sufficient skills in reading and writing in Swedish |
| Key exclusion criteria | 1. Initiated a sober period/abstinence goal before inclusion 2. A severe psychiatric or somatic comorbidity, e.g., psychosis, bipolar disorder, liver disease with transaminase levels exceeding three times clinical cutoffs, ongoing treatment for a severe cardiovascular disease, and cancer |
| Date of first enrolment | 01/01/2023 |
| Date of final enrolment | 31/01/2025 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Stockholm
11435
Sweden
Sponsor information
Industry
Tomtebodavägen 18A
5th floor
Stockholm
171 77
Sweden
| Phone | +46 8-524 800 00 |
|---|---|
| Nitya.jayaram@ki.se | |
| Website | http://karolinskainnovations.ki.se/ |
"ROR" |
https://ror.org/056d84691 |
Funders
Funder type
Industry
No information available
Government organisation / Local government
- Alternative name(s)
- Swedish Research Council for Health, Working Life and Welfare, FORTE
- Location
- Sweden
Results and Publications
| Intention to publish date | 31/08/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be considered to be available upon request by the principal investigator: Sven Andreasson, sven.andreasson@ki.se |
Editorial Notes
15/11/2024: Trial's existence confirmed by Etikprövningsmyndigheten (Swedish Ethical Review Authority).
