Over the Counter Codeine Use Misuse and Dependence (CODEMISUSED)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/6910
• EU PAS number:
  EUPAS4708
• Study ID:
  6910
• Official title and acronym:
  Over the Counter Codeine Use Misuse and Dependence (CODEMISUSED)
• DARWIN EU® study:
  No
• Study countries:
  Ireland

  South Africa

  United Kingdom
• Study description:
  The research aims to quantify the extent of codeine use, misuse and dependence in three countries (Ireland, United Kingdom and South Africa), with focus on therapeutic and non-therapeutic use, so as to create user profiles of use and abuse and capture individual user, pharmacy, medic and treatment provider perspectives. Data will be used to inform the design of pharmacy based brief interventions and customer monitoring systems, continuing staff training and management of appropriate treatment interventions. A mixed method approach will commence with a meta-analysis and systematic review of literature, which along with national pharmacist, medic and treatment provider surveying, will inform the design and implementation of sweep surveys of individuals purchasing OTC codeine in pharmacies, internet based codeine user focus groups targeting web based sales and use, and interviews with codeine users, mis-users and dependents in each country.
• Study status:
  Planned

Research institutions and networks

Institutions

Waterford Institute of Technology

School of Health Sciences, Waterford Institute of Technology (WIT)

Ireland

King's College London

Waterford Institute of Technology, School of Health Sciences Ireland, South African Medical Research Council, Alcohol and Drug Abuse Research Unit South Africa, Kings College London United Kingdom

Study timelines

Date when funding contract was signed

Actual: 22/08/2013

Study start date

Planned: 01/09/2013

Data analysis start date

Planned: 01/12/2013

Date of interim report, if expected

Planned: 01/09/2015

Date of final study report

Planned: 01/09/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

FP7-PEOPLE-2013-IAPP (Marie Curie)

Study protocol

Initial protocol

ANNEX START UP

Updated protocol

Annex May 13th 2014

Regulatory

• Was the study required by a regulatory body?:
  No