RFQ_Att 1_SOW.docx

STATEMENT OF WORK

(SOW)

GENERAL INFORMATION

Title of Project:

Improved outcomes of clinical trials for substance use disorders

Statement of Need and Purpose:

The goal of this project is to research improved outcomes in clinical trials for substance use disorders (SUDs), including stimulant and opioid use disorders (StUD and OUD). Specifically, we aim to examine reduced use and improved function rather than total abstinence and to see whether such endpoints may improve the effect size of medications tested for StUd and OUD. This approach and the findings will provide novel and potentially impactful information for the field, which is consistent with the overall goal of our lab, and the NIDA IRP at large, to identify barriers and develop effective treatments for patients afflicted with SUD.

Background Information:

The joint NIDA and NIAAA Clinical Psychoneuroendocrinology and Neuropsychopharmacology (CPN) laboratory conducts clinical and translational inpatient and outpatient studies to identify possible novel medications for addiction. We use a combination of state-of-the-art, innovative biobehavioral and pharmacological procedures performed under well-controlled human laboratory conditions, as well as bid data analyses using electronic health records. For example, the CPN laboratory is currently investigating the potential role of neuroendocrine pathways, such as ghrelin, GLP-1, and aldosterone, as possible new neuropharmacological targets for the treatment of SUDs. Preclinical and human approaches, as well as pharmacoepidemiological studies, are under development to shed light on the potential role of these pathways and to develop more effective medications for SUDs.

Beyond specific targets and medications, it is also important to study improved clinically relevant outcomes in the context of clinical trials. Of note, there has been a recent shift in the field recognizing reduced use, as a harm reduction outcome, to be a viable endpoint for clinical trials and possibly approval of medications for SUDs. Increasing evidence shows that reduced drug use is associated with improved functioning, better medical/psychosocial outcomes, and a range of other favorable outcomes. Understanding the relevance and implications of these improved endpoints is particularly critical for conditions such as StUD, for which no FDA-approved medication currently exists. In the alcohol field, recent studies suggest that the effect size of some medications improves when reduced alcohol use, rather than total abstinence, is examined as an outcome. These findings have numerous important implications. For example, some clinical trials and medications, which were traditionally known to be “negative” may have some positive and clinically relevant findings for patients with SUDs.

To date, numerous clinical trials have been conducted to test different pharmacotherapies for SUDs. Harmonizing and pooling data from these individual clinical trials provides a unique opportunity to test improved outcomes in diverse and large samples. Such harmonization initiatives and pooled analyses have recently led to important discoveries and paradigm shifts in SUD research and treatment.

Period of Performance:

Twelve Months from Date of Award

SCOPE OF WORK

General Requirements:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the work below:

Data management/analysis and preparation of a report comparing reduced use versus abstinence is clinical trials for stimulant use disorders.

Specific Requirements:

The objective of the proposed project is to manage and analyze harmonized datasets of StUD and OUD clinical trials to examine novel and clinically relevant outcome measures. Specifically, we aim to investigate whether changing the endpoint of clinical trials from total abstinence to reduced use may improve the effect size of some medications that have been tested in patients with SUDs. These findings will provide important information for the field and help design more efficient and clinically relevant trials in the future.

Contract staff will be responsible for pulling, organizing and cleaning the specific harmonized data. NIDA IRP will lead the development and submission of the manuscript after receiving a detailed description of the methods and results. The contractor will be completing data management and analysis for this project. We will regularly meet with the team to brainstorm about and outline the specifics of the project. The contract team will run the analyses and will send us a final report of the methods and results, which will only include aggregate data (no raw data or personally identifiable information).

GOVERNMENT RESPONSIBILITIES

There are no specific responsibilities to the government. NIDA IRP will lead the development and submission of the manuscript after they receive the aggregate data (i.e., a summary of the methods and results).

DELIVERY OR DELIVERABLES

Deliverables include a comprehensive and detailed summary of the method and results. The deliverables will be used by NIDA IRP to develop (in collaboration with the contract team) one or more peer-review publications to disseminate the findings to the scientific community.

REPORTING REQUIREMENTS

There are no specific reporting requirements for this project. We will regularly meet and discuss the progress. We will not receive any raw data or personally identifiable information. Only aggregate information will be received.

TRAVEL

N/A

KEY PERSONNEL

The contract team is responsible for the data management and analysis on this project and will contribute to abstract and manuscript preparation as well.

OTHER CONSIDERATIONS

Data Rights:

The contract team will abide by outlined standards of only sharing De-identified data if and when necessary. Sharing requires approval of the research proposal. Only aggregate information and data will be shared with the NIDA IRP investigators. No personal identifiable information or raw data will be shared with the NIDA IRP investigators.

Publications and Publicity:

The contractor will contribute to abstracts and manuscripts as a result of this project. NIDA IRP will lead the development and submission of the final manuscript(s) for publication.

Confidentiality of Information:

The government will not be providing any confidential information to the contractor. All data and results are confidential until reported to the public in resulting manuscript. Aggregate results will be reported and no person-level data will be identifiable.