Development of a Patient-Reported Outcomes Instrument to Measure Clinical Effectiveness of Drug Use Reduction Efforts

Project: Research project

Project Details


1. BACKGROUND AND RATIONALE Addictive processes commonly have far-reaching effects on human functioning. That is, addiction impacts quality of life, social relationships, and overall psychosocial functioning. These consequences for the individual user, for significant others, and for society drive personal and societal concerns about addiction. Addiction treatments will be most effective to the extent that they reduce the myriad of negative consequences of drug use. However, levels of drug use are not necessarily tightly coupled to these consequences. Therefore, measures of levels of drug use cannot represent all significant sequelae of drug dependence. Instead, a comprehensive appraisal of the impact of a treatment on functioning will have to address outcomes beyond use.1 Efforts are underway to identify the key outcomes for assessing treatment impact. A recent NIDA-sponsored panel generated a list of 22 potential outcomes for inclusion in drug treatment research. From these 22 outcomes, the panel selected 5 thought to best represent strong, concurrent association with excessive drug use; broad clinical or societal salience and relevance; frequency across abused substances; ease of administration and strong psychometric properties; and replicable evidence that the outcome can be altered following treatment. The 5 outcomes are: craving, quality of life, change self-efficacy, psychosocial functioning, and network support/social support.1 Additional work is needed to confirm the best outcomes for inclusion in drug treatment research and to create an instrument to measure these outcomes. 2. OBJECTIVES To demonstrate that drug use reduction efforts among addicts can lead to clinical benefits such as reduced negative consequences of drug use, increased quality of life, self-efficacy, social network support and psychosocial functioning. It is expected that a Patient-Reported Outcome (PRO) instrument could measure changes in these and other important categories during a clinical trial of a drug abuse treatment, and lead to possible FDA acceptance of this new instrument as a trial-specific endpoint. To adhere to FDA standards for PRO development, a new PRO instrument should be conceptually grounded and embedded in a study-specific endpoint model. As such, the aims of the current project are to:
Effective start/end date8/15/1512/31/16


  • The EMMES Corporation (Agmt 8/15/16 // HHSN271201500065C)
  • National Institute on Drug Abuse (Agmt 8/15/16 // HHSN271201500065C)


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