Home » Trials » Trial #265 » original TRDS
SLCTR Registration Number
SLCTR/2014/021
Date of Registration
The date of last modification
Jul 22, 2015
View original TRDS
Scientific Title of Trial
Efficacy of two treatment strategies for chronic alcohol use disorders in comparison to that currently practiced at the Psychiatric Unit of the University of Colombo - a RCT
Public Title of Trial
Testing clinical effectiveness of two alcohol treatment approaches in Sri Lanka
Disease or Health Condition(s) Studied
Harmful use of alcohol and Alcohol dependence
Scientific Acronym
ETAT-RCT
Public Acronym
ETAT-RCT
Brief title
None
Universal Trial Number
U1111-1159-9229
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
Will alcohol consumption reduce and related attitudes and behaviours improve in patients with alcohol use disorders who receive either of the two treatment approaches for 12 months to a significantly greater degree when compared with individuals who receive usual treatment?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded
Control
Standard therapy
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 4
Intervention(s) planned
Disulfiram Treatment Approach (DTA): This treatment approach, which would be conducted at University Psychiatry Unit at National Hospital of Sri Lanka, Colombo, would be characterised by disulfiram prescription with adequate medical monitoring, shifting responsibility of adherence to therapy to patient, involvement of family in active therapy and close monitoring.
Mel Medura Treatment Approach (MTA): This multi-modal psychosocial treatment approach, which is available at Sumithrayo Mel Medura, Colombo, is characterised by transformation of the 'false' positive image of alcohol in the client as well as in others, assertiveness training, some features of cognitive behaviour therapy, motivational enhancement therapy, social networking and environment-based therapies and other novel introductions
Usual Treatment Approach (UTA): Patients will receive follow up appointments at clinic or Day Unit, medication if relevant and services (supportive therapy and motivational interviewing) from the multidisciplinary team. They receive more intensive input at Day Unit while one doctor acts as the main therapist. Patients followed up at clinic may be seen by various doctors at each visit. Patients’ care can be transferred from one service to other at times.
Inclusion criteria
Meeting diagnostic criteria for harmful use of alcohol (F10.1 in lCD 10)/ alcohol abuse (305.00 in DSMIV) or alcohol dependence syndrome (F10.2 in lCD10)/ alcohol dependence (303.90 in DSMIV).
Age 14 years or above with consent from parents/ guardian if age is below 18.
Ability to communicate in Sinhala to a level commensurate with completing the recruitment assessment.
Exclusion criteria
Meeting MINI (Mini International Neuropsychiatric Interview) diagnostic criteria for psychotic disorders and mood disorder with psychotic features (lifetime).
Having a past or current history of following conditions being clearly reported by patient or in available documents such as diagnosis cards: cardiac failure, coronary artery disease, history of cerebrovascular accident, hypertension.
Psychiatrist recommending a specific treatment approach (DTA, MTA or UTA) over others.
Primary outcome(s)
|
1.
The amount of alcohol drunk in the preceding month via Alcohol Use Disorders Identification Test (AUDIT) and by Time Line Fellow Back (TLFB) instruments. |
[ 0, 6 and 12 months, and 24 months ] |
Secondary outcome(s)
|
1.
|
[ 0, 6 and 12 months, and 24 months ] |
Target number/sample size
192
Countries of recruitment
Sri Lanka
Anticipated start date
2014-11-05
Anticipated end date
2016-09-13
Date of first enrollment
Date of study completion
Recruitment status
Recruiting
Funding source
University Research Grant 2012, University of Colombo.
Regulatory approvals
Status
Date of Approval
Approval number
Details of Ethics Review Committee
| Name: | |
| Institutional Address: | |
| Telephone: | |
| Email: |
Contact person for Scientific Queries/Principal Investigator
Mahesh Rajasuriya
Senior Lecturer
Department of Psychological Medicine, Faculty of Medicine, Kynsey Road, Colombo 08
0112691688
0773552612
0112691581
Mahesh.Rajasuriya@gmail.com
Contact Person for Public Queries
Mahesh Rajasuriya
Senior Lecturer
Department of Psychological Medicine, Faculty of Medicine, Kynsey Road, Colombo 08
0112691688
0773552612
0112691581
Mahesh.Rajasuriya@gmail.com
Primary study sponsor/organization
University of Colombo
94, Cumaratunga Munidasa Mawath, Colombo 3
011 2581835
011 2583810
registrar@admin.cmb.ac.lk
http:/www.cmb.ac.lk/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
