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The Interventions domains in SDTM capture general-observation class domains are used to represent investigational, therapeutic, and other treatments that are products administered to the a subject (with some actual or expected physiological effect) either as specified by the study protocol (e.g.protocol—for example, exposure to study product  product coincident with the study assessment period (e.g., concomitant medications), or —or self‑administered by the subject (e.g., use of alcohol, tobacco, or caffeine).

Recreational drugs are chemical substances taken for enjoyment , or leisure purposes, rather than for medical reasons. They are often drugs that are misused or abused or drugs self-administered by the subject. To support standardization, CDISC defined a Substance Use (SU) domain. This domain is used to represent intervention that are Substance Use (SU )interventions interventions that involve substances used for non-medical purposes and  which often maybe may be harmful to the individual or others. These include  (e.g., alcohol, marijuana and , tobacco).   

Other domains have been established to record other types of interventions. Interventions administered to the subject coincident with the study assessment period are referred to as "concomitant medications" and represented in the SDTM Concomitant/Prior Medications (CM) domain and; interventions administered as protocol-specified study products are represented in the Exposure (EX) and Exposure as Collected (EC) domains.

In clinical trials studying tobacco products, tobacco products being used for non-medical purpose purposes will be represented in the SU domain. However, products being used to reduce the usage of these self-administered tobacco products , will be considered either concomitant medications , or the product under study.  

Several The examples are provided below to here illustrate the different ways the subjectsa subject's history of recreational product usage may be collected in studies.

Note, that :

• The Findings About Events or Interventions structure (

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• "FA structure") is used to represent collected data that are findings

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• about an event or intervention that cannot be represented within an event or intervention record or as a supplemental qualifier to such a record. Not all findings associated with an event or intervention should be represented in the FA structure.
• The Findings About Events or Interventions (FA–)   is a specialization of the Findings general observation class. it It shares all qualities and conventions of Findings findings observations but is specialized by the addition of the --OBJ variable. 

In this example, the sponsor collected information on previous medically recognized products used to reduce nicotine dependency at the baseline visit. The sposnor only collected details on the last attempt to reduce nicotine dependency for each type of product used. These products are represented in the Concomitant Medication (CM) domain.

This example is an additional example of data collected on the previous use of smoking cessation products at the baseline visit.  This example illustrates the use of CMOCCUR and CMPRESP. The reason why a product was discontinued and any use in the last 14 days was of interest.