Addiction CRO

Clinical Development in Addictions – Partner with a Specialized CRO

Addiction is a complex disease, often chronic in nature, which affects the functioning of the brain and the body. Substance use disorder studies require specialized expertise, knowledge, and relationships to get your study up and running quickly. With Lotus as your partner, you can ensure well established site relationships, experience with the complexities of navigating regulatory and recruitment models, and access to industry-leading subject matter experts with years of experience conducting clinical trials in a variety of substance use disorders.

Addiction Studies

Tobacco Studies

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Sites with Addiction Expertise

Note: Statistics combine experience from both Lotus Clinical Research and Evolution Research Group’s network of clinical research sites

Experience Across a Spectrum of Addictions

Lotus–in combination with ERG’s network of specialized investigator sites—have extensive expertise and experience that spans a wide range of addiction clinical research.

Key Indications Include:

Industry-Leading Addiction Experts

For US-based studies, Lotus is able to leverage the extensive experience and specialized skills of ERG’s site network and industry-leading Principal Investigators. With a deep knowledge of the regulatory requirements required to work with controlled substances in clinical and research settings, our teams are experienced in injection, oral, nasal, infusion, and adhesion delivery systems. In addition, ERG’s clinicians are certified by the Substance Abuse and Mental Health Services Administration (SAMHSA) in the use of buprenorphine and have the necessary skills to provide patient counseling.

Our experts are certified to administer and review a wide range of screening, diagnostic, and assessment scales used in addiction studies including:

The Addiction Severity Index (ASI)
Structured Clinical Interview for DSM-IV (SCID)
Modified Mini International Neuropsychiatric Interview Screen (MINI)
DSM V for diagnosis
CAGE Questionnaire
Michigan Alcohol Screen Testing (MAST)
Alcohol Use Disorders Identification Test (AUDIT) for screening
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)

Human Abuse Potential Studies

Lotus has leveraged the growth of its expertise, regulatory experience, and services in analgesics to conduct clinical trials involving investigational agents for acute and chronic pain indications that do not put patients at risk for addiction. Lotus understands the importance and unique challenges of running these Human Abuse Potential trials in patients who are recreational users. We have access to this subject population and possess the experience to execute these studies efficiently and safely.