Plain English Summary
Background and study aims
In Sweden 4 % of the population is estimated to fulfill criteria for alcohol dependence. A majority of these individuals with good social and psychiatric conditions suffer from mild to moderate severity of dependence. There are effective treatment methods for alcohol dependence today. However, only 20% of the dependent population receives treatment today, and the treatment facilities are mostly adjusted for the more severely affected patients. Several research studies indicate that a larger proportion of individuals with alcohol dependence would seek treatment for their problems if they found suitable treatment facilities. For individuals with mild to moderate alcohol dependence, primary care and occupational health services may be ideal treatment facilities. Historically, treatment within primary care has mainly been in the form of screening and brief intervention (1-2 advisory sessions) for individuals with a hazardous alcohol consumption. However, recent research has shown that structured and moderately extensive treatment programs can be carried out by doctors and nurses with no specialized competence within the field of dependence treatment. In the present study, the effectiveness and feasibility of implementing a treatment model for alcohol dependence within primary care is studied.
Who can participate?
Male and female, >18 years of age with alcohol dependence.
What does the study involve?
300 alcohol dependent patients are treated either within a primary care unit or within a specialized treatment facility. The treatment method is an extended brief intervention model comprising any or a combination of the following: 1) Assessment (biological markers and questionnaires plus follow up session; 2) Pharmacological treatment (treatment with the medicinal drugs acamprosate, naltrexone, disulfiram, nalmefene) and a manualized psychosocial treatment comprising four sessions covering the following topics: goal with alcohol consumption (no consumption or controlled consumption), handling risk situations, setting up a coping skills plan and implementation/maintenance. Pharmacological and psychosocial treatment can be provided either alone or in combination.
What are the possible benefits and risks of participating?
No specific benefits or risks will be expected from participating in the study.
Where is the study run from?
The study is carried out within 15 primary care units in the Stockholm municipality and a specialized unit within Addiction Centre Stockholm.
When is the study starting and how long is it expected to run for?
The study will take place between mid 2013 and June 2016.
Who is funding the study?
The study is funded by the Swedish Council for Working Life and Social Research (FAS) and by the regional agreement on medical training and clinical research (ALF) between Stockholm County Council and Karolinska Institutet.
Who is the main contact?
Professor Sven Andreasson
sven.andreasson@sll.se
Trial website
Contact information
Type
Scientific
Primary contact
Prof Sven Andreasson
ORCID ID
http://orcid.org/0000-0003-0258-5762
Contact details
Karolinska Institutet
Centre for psychiatric Research
Stockholm
11435
Sweden
-
sven.andreasson@sll.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Treatment of Alcohol dependence in Primary care - implementation and effects
Acronym
TAP
Study hypothesis
Current hypothesis as of 23/08/2013:
For patients with mild to moderate severity of alcohol dependence, participating in an extended brief intervention (psychosocial and/or pharmacological treatment) carried out within primary care will be equally effective as when carried out within a specialized treatment facility for alcohol dependence measured by change in participants´ alcohol consumption (grams per week)
Previous hypothesis:
For patients with mild to moderate severity of alcohol dependence, participating in an extended brief intervention (psychosocial and/or pharmacological treatment) carried out within primary care will be equally effective as when carried out within a specialized treatment facility for alcohol dependence as measured by number of days with any alcohol consumption and number of days with heavy drinking during 6 and 12 months after inclusion.
Ethics approval
Regional ethics board in Stockholm, 07/11/2012, ref: (Dnr 2012/1760-31/1)
Study design
Single-centre non-inferiority randomized controlled trial between-groups design
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Alcohol dependence
Intervention
Extended brief intervention (psychosocial and/or pharmacological treatment) conducted by either primary care or a specialized clinic for a dependence treatment.
Patients are treated for 6 months.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Current primary outcome measures as of 23/08/2013:
Change of weekly alcohol consumption measured in grams of alcohol at baseline, defined as 30 days before inclusion, compared to 12 months after start of treatment, defined as 30 days before the 12-month follow-up visit. Comparisons will be made between participants treated in primary care and specialist care.
Previous primary outcome measures:
1. Proportion of days with any drinking during treatment and follow-up
2. Proportion of days with heavy drinking during treatment and follow-up
Measured at 6 and 12 months following inclusion in study
Secondary outcome measures
Current secondary outcome measures as of 23/08/2013:
All with baseline measures compared with measures at follow-up 6 and 12 months after start of treatment in the study, except for the first measure with follow-up 6 months after inclusion in the study.
1. Change of weekly alcohol consumption measured in grams of alcohol
2. Change of days with heavy drinking (cut off women > 3/men >4 standard units with 12 grams of alcohol) per week
3. Change of hazardous and harmful drinking
4. Change of degree of alcohol dependence
5. Change of consequences of drinking
6. Change of symptoms of anxiety and depression
7. Change of quality of life
8. Change of levels of carbohydrate-deficient transferring (CDT)
9. Change of levels of aspartate aminotransferase (AST)
10. Change of levels of alanine aminotransferase (ALT)
11. Change of levels of gamma-glutamyltransferase (GGT)
Measure at follow-up 6 and 12 months after start of treatment in the study.
12. Satisfaction with treatment
Comparisons will be made between participants treated in primary care and specialist care.
Previous secondary outcome measures:
1. Severity of dependence
2. Psychiatric health
3. Percieved quality of life
4. Biological markers
Measured at 6 and 12 months following inclusion in study
Overall trial start date
01/04/2013
Overall trial end date
01/06/2016
Reason abandoned
Eligibility
Participant inclusion criteria
1. Alcohol dependence according to ICD-10 criteria
2. Male and female, >18 years of age
3. Housing in Stockholm municipality
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
300
Participant exclusion criteria
1. Extensive social problems
2. Withdrawal symptoms
3. Abuse or dependence of other substances apart from alcohol and/or nicotine
4. Severe psychiatric and/or somatic illness
5. Non-Swedish speaking
Recruitment start date
28/10/2013
Recruitment end date
04/03/2015
Locations
Countries of recruitment
Sweden
Trial participating centre
Karolinska Institutet
Stockholm
11435
Sweden
Sponsor information
Organisation
Addiction Centre Stockholm (Beroendecentrum Stockholm) (Sweden)
Sponsor details
Folkungagatan 44
Stockholm
11895
Sweden
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research council
Funder name
Swedish Council for Working Life and Social Research (Sweden) (2012-0567)
Alternative name(s)
Swedish Council for Working Life and Social Research, FAS
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Sweden
Funder name
Swedish Research Council funding for clinical research in medicine (Sweden) (20120273)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We are planning on publishing the results from the 6-month follow-up and the 12-month follow-up (in two separate papers) during 2016. Further analysis of the data to be confirmed at a later date.
Intention to publish date
Participant level data
Available on request
Results - basic reporting
Publication summary