Conducting randomised controlled trials of psychological Interventions in the field of drug addiction trials and tribulations

Abstract EN

Background : we have completed a randomized controlled trial (RCT) of the effectiveness of enhanced prevention counseling (EPC) in the primary prevention of Hepatitis C viral (HCV) infection in injecting drug users (IDU).

In the conduct of the trial we faced many challenges, which have not enabled us to recruit the required number of participants.

Hence, we were not able to demonstrate the effectiveness of EPC in decreasing the incidence of HCV in IDUs.

Objective : to describe the challenges encountered in carrying out the RCT and critically discuss their implications for conducting RCTs of psychological interventions in the field of drug addiction.

Method : the challenges faced were organized into 3 main themes : issues relating to the type of the client group, behavior and health ; issues relating to the service environment from which participants were recruited ; and issues relating to the trial design.

Results : the main challenges encountered were related to the chaotic behavior and motivation of drug users, to the high disengagement rates with the treatment ; to issues relating to the service environment such as the definition of IDU, HCV methods of testing and to the variation in service setup ; to issues relating to research design including compensation for participation and the use of trained regular staff rather than dedicated research workers as therapists.

Conclusion : the main lessons learnt were that piloting of a new intervention is a crucial first step before conducting pragmatic RCTs of psychological interventions in the field of addiction ; that an infrastructure and culture for psychosocial interventions is needed to enable applied research in the service environment, and research funding is needed for enabling the recruitment of dedicated trained therapists for the delivery of these interventions.