Applications sought for new methods to support outpatient drug abuse treatment studies
July 31, 2014
The National Institutes of Health's National Institute on Drug Abuse is seeking applications from researchers that propose to develop non-invasive or minimally invasive methods to support outpatient clinical trials of pharmacotherapies for Substance Use Disorders.
The announcement has two main aims: The first aim is to encourage the development of devices/techniques that will improve estimations of a subject's consumption of an abused drug (i.e.: both quantity and frequency of consumption) during an outpatient clinical trial. Such a system would allow the objective assessment of whether a medication reduces drug abuse, even if abstinence is not achieved. Proposed solutions should be able to assess systemic drug levels and be safe, portable, affordable and simple enough for subjects to take multiple samples at home and return them to the clinic for batch analysis.
The second aim of this funding opportunity announcement is to develop new, improved markers to evaluate a subject's adherence to the study medication. The goal is for investigators to be able to determine the level of systemic medication exposure throughout a study.
Assays should be applicable to at least one of the following situations:
1. Assessment of medication adherence in a manner suitable for use in a clinical setting. Candidate systems should be affordable and produce rapid results, as well as being imperceptible to subjects with no impact on their daily activities.
2. The quantitative assessment of medication adherence throughout an outpatient clinical trial.
The budget for direct costs may be up to $500,000 per year for a maximum of three years.
Applications are due Tuesday, Oct. 5.