Characteristics of Ongoing Clinical Trials for Cocaine Use Disorder Registered on Global Clinical Trial Databases

Characteristics of Ongoing Clinical Trials for Cocaine Use Disorder Registered on Global Clinical Trial Databases

Published: July/August 2026
Journal Article

Overview

This one-hour, journal article-based activity examines ongoing clinical trials for cocaine use disorder (CUD) and evaluates how well ongoing studies align with recent Food and Drug Administration (FDA) recommendations. Learners will explore trends in trial design, including the use of pharmacologic, behavioral, device-based, and digital interventions, while examining common strengths and gaps in current research. The activity also discusses how adherence to regulatory guidance may influence the development, evaluation, and future implementation of effective treatments for CUD.   

The target audience for this intermediate continuing education activity includes physicians, nurse practitioners, physician assistants, and other clinicians, researchers, students, and policymakers. 

This activity addresses the following ACGME Core Competencies: Medical Knowledge, Practice-Based Learning and Improvement, and Systems-Based Practice.

Abstract

Aims 

Cocaine use disorder (CUD) affects 1.4 million people in the United States, yet no FDA-approved treatments exist. In 2023, the Food and Drug Administration (FDA) released a draft guideline on treatments for stimulant use disorders, providing direction for trial design, outcomes, and population selection. In this study, we aimed to review ongoing clinical trials for CUD and assess their alignment with the FDA’s recommendations.

Methods

We conducted a systematic search of the 6 major clinical trial databases (United States, Australia, Canada, Iran, Netherlands, and Switzerland) to identify ongoing interventional studies for CUD. We included trials evaluating pharmacological, behavioral, device-based, and mixed treatments. We extracted data on intervention type, target population, study design, duration, and primary outcomes. Trials were assessed for alignment with 5 key FDA recommendations, including trial duration, use of both self-reported and biological outcome measures, randomization, placebo control, and double blinding.

Results

In total, 38 trials were identified, primarily from the United States (32). Most trials were randomized: 36 (94.7%), while 21 (55.3%) trials had combined endpoints or a 3-month minimum duration. Only 7 trials (18.4%) met all 5 key FDA recommendations. New treatment approaches were identified, including psilocybin and the dAd5GNE vaccine, as well as digital platforms for behavioral therapies.

Conclusion

A variety of promising treatments for CUD are under investigation. However, many trials fall short of current FDA design recommendations. Improved adherence to regulatory guidance and stronger collaboration between researchers and regulators will be essential to advance effective, scalable treatments for CUD.

Learning Objectives

Upon completion of this activity, learners will be able to:

1. Compare the design characteristics of ongoing clinical trials for CUD with current FDA recommendations. 
2. Identify emerging pharmacologic, behavioral, device-based, and digital treatment approaches currently being investigated for CUD.  
3. Evaluate limitations in the current clinical trial designs and their implications for future treatment development and regulatory approval. 

Registration Rates

*Residents, Fellows-in-training, Interns, and Students must join ASAM to receive a discounted registration rate. Click here to become an ASAM member. National and Chapter membership dues apply. There is no charge for Students to become a Member, but verification of student status is required.

Membership Question?  Call ASAM at 1.301.656.3920, email us, or view the ASAM website for more information.

Refunds & Cancellations

All ASAM eLearning Center refund requests must be made in writing to [email protected] within 90 days of purchase. Those requesting refunds for courses that are in progress will receive partial refunds or eLearning Center credit. Automatic full refunds will be made for any course with a live-course component that has been canceled.

Open Registration: 07/30/2026 - 02/10/2029

Close Access Date: 02/10/2029

Course Instructions

1. Click on the Contents tab to begin this activity.
2. Click Download Journal Article in the box titled Journal Article and read the journal article in its entirety. 
3. Click Complete Post-Test to answer multiple-choice questions. You will have 10 attempts to pass and must answer 2 out of 3 questions correctly.
4. Click Complete Evaluation to provide valuable activity feedback. Scroll down on all questions, as there may be answer options that expand past the size of the window.
5. Click the button Claim Medical Credits in the box titled Claim Credits & Certificate. Choose the type of credit and click submit. Click the button View/Print Certificate to save or print your certificate. You can view/print your certificate at any time by visiting the ASAM eLearning Center, clicking Dashboard, and clicking Transcript/Achievements.

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Accreditation & Credits

Joint Accreditation Statement

In support of improving patient care, the American Society of Addiction Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

Credits Available

• Physicians: 1.00 Credit
• Nurses & NPs: 1.00 Nursing Contact Hour
• PAs: 1.00 Credit
• Pharmacology Hour: 1 Hour
• Interprofessional Continuing Education: 1.00 Credit
• Certified Counselors: NBCC Contact Hours Not Offered

   American Society of Addiction Medicine has been approved by NBCC as an Approved Continuing Education Provider, ACEP No. 7062. Programs that do not qualify for NBCC credit are clearly identified. American Society of Addiction Medicine is solely responsible for all aspects of the programs.

Maintenance of Certification (MOC)/Continuing Certification Program (CCP)

This activity is designed to meet the requirements for MOC/CCP for several primary physician boards and for state licensing CME requirements. MOC Credit is only reported and designated for ABA, ABP, ABIM, and ABS. By completing the online credit application and evaluation, the learner permits ASAM to report credits to the appropriate Board. Learn more.

• ABIM MOC Points: 1.00 Medical Knowledge
• ABP MOC: 1.00 Lifelong Learning & Self-Assessment
• ABS Continuing Certification: 1.00 Accredited CME
• ABA MOCA 2.0®*: 1.00 Lifelong Learning MOCA 2.0® is a trademark of the American Board of Anesthesiology®. This activity contributes to the CME requirement for Part II: Lifelong Learning and Self-Assessment of the American Board of Anesthesiology's (ABA) redesigned Maintenance of Certification in Anesthesiology Program® (MOCA®), known as MOCA 2.0®. Please consult the ABA website, https://www.theaba.org/, for a list of all MOCA 2.0 requirements.

Additionally, this activity has been designed to satisfy the requirements of the following primary physician board certification requirements. Please confirm with your individual Board.

• American Board of Preventive Medicine (ABPM)
• American Board of Psychiatry and Neurology (ABPN)
• Royal College of Physicians and Surgeons of Canada (RCPSC)

Certificates for other professions

All participants may request a certificate of participation upon completion of the activity and an online evaluation confirming their participation. Learners are strongly advised to contact their professional licensing board or professional association to confirm this certificate will be accepted as evidence supporting continuing education requirements.

Disclosure Information

In accordance with the disclosure policies of ASAM and Joint Accreditation, the effort is made to ensure balance, independence, objectivity, and scientific rigor in all accredited continuing education activities. These policies include identifying and mitigating all relevant financial relationships with ineligible companies for those involved in the creation and dissemination of accredited continuing education. 

See the attached article and pdf for a list of disclosures