36C24126Q0708.docx

Sources Sought Notice Sources Sought Notice

GENERAL INFORMATION

Network Contracting Office 1 (NCO 1) Contracting Officer (90C) 1 VA Center Augusta ME 04330

POINT OF CONTACT*

Lauren Reed-Smart Lauren M Reed-Smart-Contractor lauren.reed-smart@va.gov 603-686-6418

PLACE OF PERFORMANCE

830 Chalkstone Ave

Providence RI

COUNTRY

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

DESCRIPTION

SOURCES SOUGHT NOTICE

This is a Sources Sought Notice only. It is not a Request for Proposal (RFP), Request for Quotation (RFQ), or Invitation for Bid (IFB), and it does not obligate the Government to award a contract. This notice is for market research and planning purposes only.

Title: MDMA-Assisted Therapy Services in Support of PTSD-AUD Clinical Trial Sources Sought Number:

Issuing Office: Department of Veterans Affairs, VA Providence Healthcare System Anticipated NAICS Code: 621330 – Offices of Mental Health Practitioners (Except Physicians) Anticipated Set-Aside: Small Business Set-Aside Place of Performance: VA Providence Healthcare System, 830 Chalkstone Ave, Providence, RI 02908; this is NOT a remote position Anticipated Period of Performance: Base period of 12 months plus four (4) 12-month option years Anticipated Contract Type: Labor Hour Indefinite Delivery/Indefinite Quantity (IDIQ), non-personal services contract

1. PURPOSE

The Department of Veterans Affairs (VA), VA Providence Healthcare System, is conducting market research to identify qualified sources capable of providing licensed clinical therapy services in support of a randomized, placebo-controlled clinical trial of MDMA-assisted therapy in military Veterans with co-occurring Post-Traumatic Stress Disorder and Alcohol Use Disorder (PTSD-AUD). This notice is issued solely for information and planning purposes to determine the availability and technical capability of qualified sources, including the availability of small businesses in relevant socioeconomic categories, prior to determining the appropriate acquisition strategy.

2. SCOPE OF ANTICIPATED REQUIREMENT

The Contractor shall provide licensed clinical therapy services in support of the MDMA-assisted therapy treatment protocol described above, in accordance with the approved clinical trial protocol, treatment manual, and all applicable VA, FDA, and Human Subjects Research requirements. This is anticipated to be a non-personal services contract; the Contractor would retain full responsibility for and control over the clinical methods, manner, and means by which services are performed, consistent with the Contractor's independent professional and ethical obligations under applicable licensure standards.

The Contractor would provide approximately 64.5 hours of therapy per participant, consisting of:

Anticipated tasks include:

· Serving as a co-therapist on MDMA-assisted therapy dyads in accordance with the study treatment manual

· Conducting protocol-specific preparatory psychotherapy sessions

· Providing in-person therapeutic support during experimental medication sessions (~8 hours each), including continuous psychological support and monitoring

· Conducting post-experimental integration sessions

· Participating in protocol fidelity monitoring and supervision

· Completing required clinical and research documentation within VA-approved systems (e.g., CPRS/REDCap)

· Coordinating with the PI, study physician, and research staff regarding participant safety and adverse events

· Participating in multidisciplinary case review meetings

3. ANTICIPATED QUALIFICATIONS

Interested sources should generally possess the following:

General Qualifications:

· Licensed therapist experienced in delivering trauma-focused psychotherapy to adults with complex trauma presentations, including co-occurring substance use disorders

· Skilled in comprehensive risk assessment, crisis intervention, and safety planning, particularly with populations at elevated risk for suicidality or acute emotional dysregulation

· Experience with military Veterans and understanding of Veteran-specific clinical and cultural considerations

· Trained in evidence-based trauma treatment modalities (e.g., TF-CBT) Specialized Qualifications:

· Current independent licensure (LMFT, LICSW, LMHC, Psychologist, or equivalent)

· Advanced training in trauma-focused psychotherapy

· Formal training in MDMA-assisted therapy through a MAPS-recognized or equivalent therapist training program (didactic instruction, experiential learning, and supervised practice), with core competencies in preparation/integration therapy, therapeutic stance and rapport-building, safety monitoring, management of altered states of consciousness, trauma processing, ethical considerations, and protocol fidelity

· Prior direct clinical experience serving as a therapist in an MDMA-assisted therapy or related psychedelic-assisted psychotherapy clinical trial, involving a similar population (e.g., Veterans with co-occurring PTSD and substance use disorder)

· Experience treating co-occurring PTSD and substance use disorders

· Competency in suicide risk assessment, crisis stabilization, and management of acute emotional dysregulation

4. RESEARCH COMPLIANCE

Any resulting contract will require compliance with:

· VA Central IRB requirements

· VA Research and Development guidelines

· FDA IND requirements

· Good Clinical Practice (GCP)

· Human Subjects Protection regulations (45 CFR 46)

· Study protocol requirements and adverse event reporting procedures

5. INSTRUCTIONS TO INTERESTED SOURCES

Interested parties who believe they possess the necessary capabilities to perform the requirements described above are invited to submit a capability statement. This is not a solicitation for proposals, and no solicitation exists at this time. Do not submit pricing information.

Capability statements should be no more than 2 pages and should address the following:

1. Company/Individual Information: Name, address, point of contact, phone number, email address, and business size/socioeconomic status (e.g., small business, SDVOSB, VOSB, WOSB, HUBZone, 8(a), or other) under the anticipated NAICS code identified above, including current SAM.gov registration status.

2. Relevant Experience: Description of experience providing MDMA-assisted therapy or related psychedelic-assisted psychotherapy in a clinical trial setting, including the population served, role performed, and outcomes if available.

3. Personnel Qualifications: Identification of the licensed clinician(s) proposed to perform this work, including licensure type and state, MAPS-recognized (or equivalent) MDMA-assisted therapy training completed, and experience with Veteran populations and co-occurring PTSD/substance use disorder treatment.

4. Organizational Capacity: Ability to meet VA credentialing, background investigation, and information security training requirements described in VA Handbook 6500.6, Appendix C, and ability to perform work on-site at VA Providence Healthcare System, 830 Chalkstone Ave, Providence, RI.

5. Contract Vehicle Experience: Any prior experience performing under federal, VA, or other government non-personal services or IDIQ contracts.

6. Teaming/Subcontracting: Indicate whether your firm intends to respond as a prime, subcontractor, or in a teaming arrangement, and identify any teaming partners.

Responses should be submitted electronically to the points of contact below no later than August 13, 2026 at 10:00AM EST.

6. DISCLAIMER

This Sources Sought Notice is issued solely for market research and information-gathering purposes in accordance with FAR Part 10. It does not constitute a solicitation and is not to be construed as a commitment by the Government to issue a solicitation or award a contract. The Government will not pay for any information or administrative costs incurred in responding to this notice. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. All information received in response to this notice that is marked as proprietary will be handled accordingly. Responses will not be returned. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted.

The Government reserves the right to reject, in whole or in part, any private sector input as a result of this notice.

7. POINTS OF CONTACT

Contracting Point of Contact (POC): Lauren Reed-Smart Email: lauren.reed-smart@va.gov

Sources Sought Notice