Family-supervised disulfiram as a culturally grounded model for alcohol use disorder treatment in Sri Lanka: a pilot randomized controlled trial

ObjectivesTo evaluate the effectiveness and cultural feasibility of family-supervised disulfiram as a first-line treatment for alcohol use disorder (AUD) in Sri Lanka, and to compare its clinical outcomes with standard therapy delivered at a tertiary psychiatric unit. DesignSingle-blind Randomized Controlled Trial known as ETAT-RCT (Efficacy of Two Alcohol Treatments) was conducted under routine clinical setup with three parallel groups: family-supervised disulfiram, locally developed psychosocial intervention, and routine treatment. Allocation was independently concealed; assessors were blinded. Analyses followed an intention-to-treat approach using repeated-measures ANOVA (group x time). This paper reports the disulfiram (test) versus routine treatment (control) comparison; the psychosocial intervention will be reported separately. SettingUniversity Psychiatry Unit, National Hospital of Sri Lanka, Colombo (UPU, NHSLC). ParticipantsPatients aged [&ge;]14 years with AUD presenting to the unit were recruited consecutively without inducements. Planned allocation ratio was 1:1:1 with 31 participants per arm; key exclusions were lifetime psychotic disorder and current contraindication to disulfiram. RandomisationParticipants were randomised into each treatment arm using an independent concealed paper-based allocation system. Intervention(1) family-supervised disulfiram, with psychoeducation/support only - DT arm, (2) a locally developed denormalization focused psychosocial programme - PT arm, and (3) standard therapy (motivational/cognitive/behavioural input; naltrexone permitted; no disulfiram/denormalisation) - ST arm. Outcome measuresPrimary outcome was Alcohol Use Disorders Identification Test (AUDIT) score at 12 months. Key secondary outcomes were past 30 day alcohol use via Timeline Follow-Back (TLFB); alcohol biomarkers [ALT (alanine aminotransferase), {gamma}-GT (gamma-glutamyl transferase), MCV (mean corpuscular volume)]; locally developed measures of addiction-relevant cognitive, affective, behavioural factors [AARSU (Attitude Assessment Related to Substance Use), BARSU (Behaviour Assessment Related to Substance Use)]; and Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF). Outcomes were assessed at baseline, 6, and 12 months. ResultsParticipants in DT (n=33) and ST (n=38) were comparable at baseline. Both groups showed clinically and statistically significant improvement in AUDIT scores over 12 months (DT: F=39.90, p<0.001; ST: F=49.90, p<0.001), with no groupxtime interaction (F<0.001, p=0.98). Biomarkers and AARSU, and BARSU and Q-LES-Q-SF to a lesser degree, mirrored the AUDIT pattern. TLFB did not change significantly over time in either arm (p>0.05). In moderator analyses, improvement in AUDIT was not moderated by baseline motivation (F=0.20, p=0.89) but was moderated by baseline AUD severity (F=7.70, p=0.007). No serious adverse events were attributed to disulfiram. Adherence to supervised dosing was generally high during periods of supervision but intermittent overall. ConclusionsIn this pilot RCT, family-supervised disulfiram achieved 12-month outcomes comparable to standard therapy in a tertiary Sri Lankan setting. Improvements were independent of baseline motivation and varied by baseline AUD severity. These findings may support family-supervised disulfiram as a culturally feasible first-line option in Sri Lanka; larger, adequately powered multicentre trials are warranted to confirm effectiveness and scalability. Trial registrationSLCTR/2014/021 Strengths and limitations of this studyO_LIThis pragmatic randomised controlled trial demonstrates an improved real world applicability and validity as it was conducted in an unmodified public-sector psychiatric setting. C_LIO_LIStrong generalisability of the study with similar health systems due to broad eligibility criteria of patients warranted the inclusion of regular and general patient cohort with alcohol use disorders, strengthening generalisability within similar health systems. C_LIO_LIInterventions were carried out without additional staff or patient monitoring reflecting routine clinical practice. C_LIO_LIComprehensive assessment beyond abstinence alone with multidimensional outcomes such as alcohol related harm, biomarkers, cognitive behavioural change and quality of life. C_LIO_LIMinor potential in performance bias due to the nature of intervention where blinding study subjects and clinicians is not feasible. C_LIO_LISampling bias towards males and variability within the ST arm can affect the generalisability. C_LI