Is treatment of alcohol dependence equally effective when carried out in primary care as in a specialized alcohol dependence clinic?

ISRCTN	ISRCTN84490505
DOI	https://doi.org/10.1186/ISRCTN84490505
Protocol serial number	N/A
Sponsor	Addiction Centre Stockholm (Beroendecentrum Stockholm) (Sweden)
Funders	Swedish Council for Working Life and Social Research (Sweden) (2012-0567), Swedish Research Council funding for clinical research in medicine (Sweden) (20120273)

Submission date: 09/01/2013
Registration date: 09/07/2013
Last edited: 30/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Prof Sven Andreasson
Scientific

Karolinska Institutet
Centre for psychiatric Research
Stockholm
11435
Sweden

ORCID ID	0000-0003-0258-5762
Email	sven.andreasson@sll.se

Study information

Primary study design	Interventional
Study design	Single-centre non-inferiority randomized controlled trial between-groups design
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Treatment of Alcohol dependence in Primary care - implementation and effects
Study acronym	TAP
Study objectives	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(s)	Regional ethics board in Stockholm, 07/11/2012, ref: (Dnr 2012/1760-31/1)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	01/06/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	300
Key inclusion criteria	1. Alcohol dependence according to ICD-10 criteria 2. Male and female, >18 years of age 3. Housing in Stockholm municipality
Key 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
Date of first enrolment	28/10/2013
Date of final enrolment	04/03/2015

Locations

Countries of recruitment

Sweden

Study participating centre

Karolinska Institutet

Stockholm
11435
Sweden

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results of 6-month follow-up	01/07/2018	30/01/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

30/01/2019: Publication reference added
On 23/08/2013 the study design was changed from "Single-centre randomized controlled trial between-groups design" to "Single-centre non-inferiority randomized controlled trial between-groups design".

On 03/11/2015 the overall trial end date was changed from 31/05/2015 to 01/06/2016.