Substance Use Disorder & Addiction

Clinical trials involving Substance Abuse and Addiction disorders have unique challenges and require a CRO with robust capabilities, highly experienced clinical site staff and specialized solutions to deliver meaningful and high-quality data. Successfully conducting these types of trials demands a deep understanding of the complexities these populations present. The Dr. Vince Clinical Research team brings significant expertise in conducting Substance Abuse and Addiction studies. Brad Vince, D.O., CEO and Chief Medical Officer, has participated in over 50 Phase I/II overnight trials involving substance abuse or dependent subjects. Multiple members of the DVCR leadership team also have extensive experience conducting similar clinical studies, with many having worked under long-term contracts with NIDA and the FDA, where Dr. Vince served as the CRO and/or site. This exceptional depth of experience positions DVCR as a leading CRO for executing these complex clinical trials.

Capabilities

Dr. Vince Clinical Research (DVCR) is a full-service CRO providing end-to-end solutions for studies in healthy volunteers and patient populations. DVCR’s extensive volunteer database represents one of the largest populations of substance users in North America that has been developed in the last decade.

Our physician-led Phase 1 clinical pharmacology unit was purpose-built for inpatient trials, specifically those involving controlled substances. The unit houses 90 beds for overnight trials, including eight private suites for individual domiciling. The safety and reputation of the DVCR research campus, combined with the luxurious amenities and infrastructure-based customer service, provide the optimal environment for volunteers to participate in our studies.  

We conduct the following studies at our Phase 1 clinical pharmacology unit and our global network of strategic site partners:

Click below to receive more information on how our CRO can support your upcoming substance use disorder and addiction trial.

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DVCR is registered with the DEA as a Researcher to handle and store Schedule I – V controlled substances. Our in-house pharmacy has been specifically constructed for the safe storage and dosage preparation of controlled substances. Features of our pharmacy include:

  • 350 lb. steel constructed, electronic safe for the secure storage of controlled substances.
  • Limited access to the pharmacy, granted via a biometric facial recognition system.
  • Dedicated locking cold storage units with continuous temperature monitoring.
  • State-of-the-art clean room with multiple Class II, Type A2 biosafety cabinets that provide an ISO 5 environment for sterile compounding in compliance with USP 797.
  • Pharmacy team with extensive sterile compounding experience and bandwidth that ensures each individual dose is accurately prepared.
Learn More About DVCR's cGMP Pharmacy

Many of these trial types involve procedures, assessments and questionnaires that are specific to substance use disorder and addiction trials, such as:

  • Visual Analog Scales (VAS)
  • Addiction Severity Index (ASI)
  • Structured Clinical Interview for DSM (SCID)
  • Mini International Neuropsychiatric Interview (MINI)
  • DSM-5 Assessment
  • CAGE Questionnaire
  • Michigan Alcohol Screen Testing (MAST)
  • Alcohol Use Disorders Identification Test (AUDIT)
  • Timeline Followback (TLFB)
  • Cocaine Craving Questionnaire (CCQ)
  • Penn Alcohol Craving Scale (PACS)
  • Yale-Brown Obsessive Compulsive Scale (YBOC)
  • Clinical Opiate Withdrawal Scale (COWS)
  • Subjective Opiate Withdrawal Scale (SOWS)
  • Quality of Life Scale (QoL)
  • Symptom Checklist 90 Revised (SCL-90 R)
  • Scales of Psychological Wellbeing (SPWB)
  • Clinical Global Impression (CGI)
  • Global Assessment of Functioning Scale (GAF)

Indications

DVCR’s medical, pharmacy, clinical operations and project management teams have experience working with the following populations:

  • Cocaine Use Disorder (CUD)
  • Substance Use Disorder (SUD)
  • Opioid Use Disorder (OUD)
  • Alcohol Use Disorder (AUD)
  • Others

Drug Classes

  • Opioids
  • Stimulants
  • Sedatives
  • Hallucinogens
  • Benzodiazepines
  • Cannabinoids
  • Psychedelics
  • Others

Meet Our Experts

DVCR is a privately owned, physician-led CRO with no revenue goals or board of directors, committed to the satisfaction of our clients and the safety of our volunteers. Therefore, we maintain a research team that understands the unique challenges of Substance Abuse and Addiction trials. The following members of our company are heavily involved in the oversight, planning, and day-to-day conduct of these clinical studies:

Bradley D. Vince, DO

CEO & Chief Medical Officer

Bio

With 25 years of experience in the clinical research industry, Dr. Brad Vince has served as an Investigator in over 700 clinical trials and authored numerous scientific publications. He also has deep industry experience in government studies, including acting as Principal Investigator for various FDA and NIH trials. In addition to founding Vince & Associates Clinical Research in 2001 and serving as president for nearly two decades, Dr. Vince has consulted for sites, CROs and biopharmaceutical companies. He is well-known in the clinical research industry for his passion, energy and 24/7/365 availability.

Lynn Webster, MD

Executive Vice President, Scientific Affairs

Bio
Dr. Webster is an internationally recognized clinical research expert in pain and addiction medicine. He has participated as an Investigator in hundreds of clinical trials and has authored more than 300 peer reviewed articles. Dr. Webster is board certified in anesthesiology, pain medicine and addiction medicine. He serves as an editor for the journal Pain Medicine and serves as a peer reviewer of several professional journals. Additionally, he is a grant reviewer for the National Institute of Health. Dr. Webster has significant expertise in clinical research, with a focus on experimental and human pain models, human abuse potential studies as well as assessing the effects of drugs on respiratory depression.

Steven Hull, MD, FCCP, FAASM

Medical Director & Principal Investigator

Bio

Dr. Steven Hull serves as Medical Director and a Principal Investigator at DVCR.  He is a seasoned researcher, having participated in more than 550 clinical trials as an Investigator or Medical Monitor. He has over 30 years of clinical experience in Pulmonary, Critical Care, and Sleep Medicine. Dr. Hull takes pride in his hands-on approach and collegiality, which provides DVCR with the medical expertise and guidance to enhance the performance, quality and oversight of the investigators and research team.

Todd Janssen, RPh

Director, Pharmacy Operations

Bio

Todd Janssen has been a practicing registered pharmacist (RPh) for over 30 years with the last 12 years focused on phase 1 clinical research. Janssen’s 12+ years of early phase experience have provided invaluable expertise in clinical trial dose preparation including nasal insufflation, powder in capsule, over-encapsulation, aseptic preparation and powder in solution applications. He received training in compounding at the Professional Compounding Centers of America (PCCA).

Justin Couture

Director, Clinical Operations

Bio

Justin Couture has been a nationally registered paramedic for over 15 years, with over a decade of work specifically in clinical research. He has held several roles in the medical research field, ranging from direct patient care to clinic supervision and project management. He is Advanced Cardiovascular Life Support (ACLS) certified and holds a master’s degree in Organizational Leadership.

Rose Gerringer

Ratings Manager

Bio

Rose Gerringer, Ratings Manager, oversees subjective data collection at DVCR. Rose brings 25 years of experience as an instructor in both corporate and academic settings to train staff and volunteers in the collection of primary endpoints for human abuse potential and acute pain models. Rose’s clinical pharmacology research experience spans 12 years with eight of those in subjective data collection and four in regulatory compliance.

Meet Our Experts

DVCR is a privately owned, physician-led CRO with no revenue goals or board of directors, committed to the satisfaction of our clients and the safety of our volunteers. Therefore, we maintain a research team that understands the unique challenges of Substance Abuse and Addiction trials. The following members of our company are heavily involved in the oversight, planning, and day-to-day conduct of these clinical studies:

Bradley D. Vince, DO

CEO & Chief Medical Officer

Bio

With 25 years of experience in the clinical research industry, Dr. Brad Vince has served as an Investigator in over 700 clinical trials and authored numerous scientific publications. He also has deep industry experience in government studies, including acting as Principal Investigator for various FDA and NIH trials. In addition to founding Vince & Associates Clinical Research in 2001 and serving as president for nearly two decades, Dr. Vince has consulted for sites, CROs and biopharmaceutical companies. He is well-known in the clinical research industry for his passion, energy and 24/7/365 availability.

Lynn Webster, MD

Executive Vice President, Scientific Affairs

Bio
Dr. Webster is an internationally recognized clinical research expert in pain and addiction medicine. He has participated as an Investigator in hundreds of clinical trials and has authored more than 300 peer reviewed articles. Dr. Webster is board certified in anesthesiology, pain medicine and addiction medicine. He serves as an editor for the journal Pain Medicine and serves as a peer reviewer of several professional journals. Additionally, he is a grant reviewer for the National Institute of Health. Dr. Webster has significant expertise in clinical research, with a focus on experimental and human pain models, human abuse potential studies as well as assessing the effects of drugs on respiratory depression.

Steven Hull, MD, FCCP, FAASM

Medical Director & Principal Investigator

Bio

Dr. Steven Hull serves as Medical Director and a Principal Investigator at DVCR.  He is a seasoned researcher, having participated in more than 550 clinical trials as an Investigator or Medical Monitor. He has over 30 years of clinical experience in Pulmonary, Critical Care, and Sleep Medicine. Dr. Hull takes pride in his hands-on approach and collegiality, which provides DVCR with the medical expertise and guidance to enhance the performance, quality and oversight of the investigators and research team.

Todd Janssen, RPh

Director, Pharmacy Operations

Bio

Todd Janssen has been a practicing registered pharmacist (RPh) for over 30 years with the last 12 years focused on phase 1 clinical research. Janssen’s 12+ years of early phase experience have provided invaluable expertise in clinical trial dose preparation including nasal insufflation, powder in capsule, over-encapsulation, aseptic preparation and powder in solution applications. He received training in compounding at the Professional Compounding Centers of America (PCCA).

Justin Couture

Director, Clinical Operations

Bio

Justin Couture has been a nationally registered paramedic for over 15 years, with over a decade of work specifically in clinical research. He has held several roles in the medical research field, ranging from direct patient care to clinic supervision and project management. He is Advanced Cardiovascular Life Support (ACLS) certified and holds a master’s degree in Organizational Leadership.

Rose Gerringer

Ratings Manager

Bio

Rose Gerringer, Ratings Manager, oversees subjective data collection at DVCR. Rose brings 25 years of experience as an instructor in both corporate and academic settings to train staff and volunteers in the collection of primary endpoints for human abuse potential and acute pain models. Rose’s clinical pharmacology research experience spans 12 years with eight of those in subjective data collection and four in regulatory compliance.

Meet Our Experts

DVCR is a privately owned, physician-led CRO with no revenue goals or board of directors, committed to the satisfaction of our clients and the safety of our volunteers. Therefore, we maintain a research team that understands the unique challenges of Substance Abuse and Addiction trials. The following members of our company are heavily involved in the oversight, planning, and day-to-day conduct of these clinical studies:

Bradley D. Vince, DO

CEO & Chief Medical Officer

Bio

With 25 years of experience in the clinical research industry, Dr. Brad Vince has served as an Investigator in over 700 clinical trials and authored numerous scientific publications. He also has deep industry experience in government studies, including acting as Principal Investigator for various FDA and NIH trials. In addition to founding Vince & Associates Clinical Research in 2001 and serving as president for nearly two decades, Dr. Vince has consulted for sites, CROs and biopharmaceutical companies. He is well-known in the clinical research industry for his passion, energy and 24/7/365 availability.

Lynn Webster, MD

Executive Vice President, Scientific Affairs

Bio
Dr. Webster is an internationally recognized clinical research expert in pain and addiction medicine. He has participated as an Investigator in hundreds of clinical trials and has authored more than 300 peer reviewed articles. Dr. Webster is board certified in anesthesiology, pain medicine and addiction medicine. He serves as an editor for the journal Pain Medicine and serves as a peer reviewer of several professional journals. Additionally, he is a grant reviewer for the National Institute of Health. Dr. Webster has significant expertise in clinical research, with a focus on experimental and human pain models, human abuse potential studies as well as assessing the effects of drugs on respiratory depression.

Steven Hull, MD, FCCP, FAASM

Medical Director & Principal Investigator

Bio

Dr. Steven Hull serves as Medical Director and a Principal Investigator at DVCR.  He is a seasoned researcher, having participated in more than 550 clinical trials as an Investigator or Medical Monitor. He has over 30 years of clinical experience in Pulmonary, Critical Care, and Sleep Medicine. Dr. Hull takes pride in his hands-on approach and collegiality, which provides DVCR with the medical expertise and guidance to enhance the performance, quality and oversight of the investigators and research team.

Todd Janssen, RPh

Director, Pharmacy Operations

Bio

Todd Janssen has been a practicing registered pharmacist (RPh) for over 30 years with the last 12 years focused on phase 1 clinical research. Janssen’s 12+ years of early phase experience have provided invaluable expertise in clinical trial dose preparation including nasal insufflation, powder in capsule, over-encapsulation, aseptic preparation and powder in solution applications. He received training in compounding at the Professional Compounding Centers of America (PCCA).

Justin Couture

Director, Clinical Operations

Bio

Justin Couture has been a nationally registered paramedic for over 15 years, with over a decade of work specifically in clinical research. He has held several roles in the medical research field, ranging from direct patient care to clinic supervision and project management. He is Advanced Cardiovascular Life Support (ACLS) certified and holds a master’s degree in Organizational Leadership.

Rose Gerringer

Ratings Manager

Bio

Rose Gerringer, Ratings Manager, oversees subjective data collection at DVCR. Rose brings 25 years of experience as an instructor in both corporate and academic settings to train staff and volunteers in the collection of primary endpoints for human abuse potential and acute pain models. Rose’s clinical pharmacology research experience spans 12 years with eight of those in subjective data collection and four in regulatory compliance.