Pill concept art

Substance Use Disorders & Addiction

50+ first-in-human (FIH) through Phase 1b and proof-of-concept (PoC) studies in substance use and dependence populations, supported by a DEA-registered clinical pharmacology unit purpose-built for controlled substances.

Discuss your substance use disorders & addiction trial
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Trials in substance use and dependence populations

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Beds purpose-built for controlled-substance trials

Schedule I–V

DEA-registered research pharmacy

NIDA + FDA

Long-term government research experience

Indications and study types

Our medical, pharmacy, clinical operations and project management teams have experience conducting clinical trials for investigational therapies targeting substance use disorders. These studies include both healthy, normal volunteers and patient populations.

Indications

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

Drug classes we have worked with include opioids, stimulants, sedatives, hallucinogens, benzodiazepines, cannabinoids, and psychedelics.

Study types

First-in-Human (FIH):
NDA-Enabling Clinical Pharmacology Studies:

Human Abuse Potential (HAP)/Human Abuse Liability (HAL)

Cocaine Interaction/Cocaine DDI

Ethanol Interaction

Smoking Cessation/Smoking Populations

Phase Ib/IIa Proof-of-Concept (POC)

Phase I-III Multicenter Patient Trials

Substance use disorders assessments

Many of these trials rely on procedures and rating instruments specific to substance use disorder research. 

Diagnostic assessments

Used to establish psychiatric and substance use disorder diagnoses and determine study eligibility.

  • Structured Clinical Interview for DSM (SCID) 
  • Mini International Neuropsychiatric Interview (MINI) 
  • DSM-5 Assessment 

Substance use screening & history

Used to identify substance use disorders, characterize severity, and document patterns of use.

  • Addiction Severity Index (ASI) 
  • Michigan Alcohol Screening Test (MAST) 
  • Alcohol Use Disorders Identification Test (AUDIT) 
  • Timeline Follow Back (TLFB) 

Craving assessments

Used to evaluate the intensity and frequency of substance cravings.

  • Cocaine Craving Questionnaire (CCQ) 
  • Penn Alcohol Craving Scale (PACS) 

Withdrawal assessments

Used to assess the severity of withdrawal symptoms during treatment or detoxification.

  • Clinical Opiate Withdrawal Scale (COWS) 
  • Subjective Opiate Withdrawal Scale (SOWS)

Symptom & behavioral assessments

Used to evaluate psychiatric symptoms, psychological health and behavioral outcomes.

  • Yale-Brown Obsessive Compulsive Scale (Y-BOCS) 
  • Symptom Checklist-90-Revised (SCL-90-R) 
  • Scales of Psychological Well-Being (SPWB) 

Global functioning & clinical outcome assessments

Used to measure overall clinical status, functioning, and treatment response.

  • Clinical Global Impression (CGI) 
  • Global Assessment of Functioning (GAF) 
  • Quality of Life Scale (QoL) 

Patient-reported outcome assessments

Used to capture participant-reported symptoms and perceptions.

  • Visual Analog Scales (VAS)
  • Rapid Visual Information (RVP)
  • Reaction Time (RTI)
  • Spatial Working Memory (SWM)

Substance use disorders & addiction studies infrastructure and partnerships

Dr Hull speaking with a peer

Clinical pharmacology unit

Our physician-led clinical pharmacology unit supports substance use disorder & addiction studies requiring inpatient stays, intensive PK sampling, continuous safety monitoring and complex multi-period designs, so studies with demanding monitoring or dosing requirements can be executed in a controlled environment. The unit accommodates both healthy volunteer and patient cohorts.

Multicenter trials

For multicenter patient trials, we draw on an established network of strategic site partners with documented experience enrolling subjects with a history of substance abuse or dependence. Site selection and ongoing oversight are managed by our Site Partnerships Team, with criteria aligned to investigator experience, enrollment performance record and data quality standards, helping sponsors achieve consistent execution across participating sites. 

Through our Lead Site Model, we can serve as both the CRO and the first enrolling clinical research unit, providing firsthand operational insight that helps strengthen protocol compliance, improve feasibility and identify potential challenges before they impact study conduct. This approach supports faster site readiness, streamlined communication between sponsors and sites and delivers consistent execution across the study lifecycle.

Lab team at work in the research lab

Central lab

Our Central Laboratory supports multicenter studies with laboratory manual development, kit production, site supply logistics and standardized specimen management. Centralized laboratory data and real-time access to results help improve data consistency across sites, supports safety oversight and streamlines study execution from startup through final reporting.

PK processing &
safety laboratory

Our CLIA-certified PK Processing & Safety Laboratory provides on-site safety testing, endpoint sample processing, and real-time access to laboratory results. Integrated technology and barcode-enabled workflows support efficient study execution, data quality and timely study decisions.

Dr vince clinical research laboratory employee

Pharmacy services

Study drug is prepared and stored on-site in our 2,500 sq. ft. cGMP-compliant pharmacy, which is DEA-registered to handle and store Schedule I-V controlled substances. The pharmacy is equipped to prepare investigational products across multiple routes of administration, including injectable formulations, nasal insufflation, powder-in-capsule, powder-in-solution and over-encapsulation. Integration within our Phase I unit enables rapid delivery of prepared doses under controlled conditions, reducing the number of handoffs, maintaining chain of custody, and delivering on-time dosing. 

Technology and data visibility

Our fully integrated technology platform, including eSource, EDC and CTMS, along with AI-driven tools help streamline data collection throughout the study. These secure, cloud-based systems provide real-time data visibility, validated audit trails, data integration and scalable access to reliable, high-quality data across the entire study lifecycle.

Our substance use disorders & addiction team

Our Substance Use Disorders & Addiction program is supported by a team with direct clinical, scientific and operational experience in psychiatry and neurology. The same team supports your study from startup through closeout. Decisions are made by the clinical and scientific experts most directly involved in the study, so sponsors have direct access to the experts responsible for their program throughout execution.

Bradley Vince, DO

CEO & Chief Medical Officer

25 years of experience

Steven Hull, MD

Medical Director & Principal Investigator

25 years of experience

Rose Gerringer

Ratings Manager

14 years of experience

Related resources

Considering DVCR for your substance use disorders & addiction Study?

Talk to a team that has extensive expertise in running trials in substance use and
dependence populations. 

We are ready to discuss your protocol and timeline and how our controlled-substance infrastructure and recruitment capabilities support a predictable execution path. We identify potential risks early and develop an execution strategy before study startup.

Request a Capabilities Meeting Download our CRO Services Info Sheet