Recreational Product Usage (including Tobacco Usage)

The Interventions domains in SDTM capture investigational, therapeutic, and other treatments that are administered to the subject (with some actual or expected physiological effect) either as specified by the study protocol (e.g., exposure to study product coincident with the study assessment period (e.g., concomitant medications), 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 used for non-medical purposes and often maybe harmful to the individual or others. These include 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 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 examples are provided below to illustrate the different ways recreational product usage may be collected in studies.

Example

This example collects data on all types of recreational products used by subjects. The sponsor only the general type of product used. The actual dates of usage were also not collected. The subject provided the duration of use. Usage of these recreational products are represented in the SU domain.

There are 2 sections of this example CRF: The questions in the first section focus on the whether any recreational products were used, and the questions in the second section are for each recreational product used. The applicant did not include subjects that did not use recreational products in the SDTM dataset. In order to save space, some of the permissible values are only shown in the metadata specifications.

Section 1 The metadata/specification in the first section focus on the whether any recreational products were used.

Order	Question Text	Prompt	Case Report Form Completion Instructions	Type	Collection Variable	Tabulation Target	Mapping Instructions	Controlled Terminology CodeList Name	Permissible Values
1	What is the category of the substance used?	Substance Use Category	Record the recreational product category, if not pre-printed on the CRF.	Text	SUCAT				RECREATIONAL PRODUCT
2	Were any recreational products used?	Any Recreational Product Used	Indicate if the subject had used any recreational products.	Text	SUYN		SUSTAT = "NOT DONE" and SUTRT="RECREATIOAL PRODUCT" where SUYN = "Not Done"	(NY)	Yes; No; Not Done
3	What was the reason the recreational product use was not done?	Reason Not Done	Record the reason recreational product use was not done.	Text	SUREASND	SUREASND

Section 2 The metadata/specification in the second section focus on each recreational product used.

Order	Question Text	Prompt	Case Report Form Completion Instructions	Type	Collection Variable	Tabulation Target	Mapping Instructions	Permissible Values	Pre-Populated Value
4	What was the recreational product used?	Type of Recreational Product Used	Record each recreational product used on a new line.	Text	SUTRT			Alcohol; Tobacco; Marijuana; Hallucinogen Drugs; Non-medical prescription drugs use; Stimulants; Other
5	Does the subject currently use or formerly used recreational products?	Usage	Check the appropriate box to indicate if the subject currently or formerly used recreational products.	Text	SUNCF	SUSTTPT; SUSTRTPT; SUENTPT; SUENRTPT; SUPRESP		(NCF)	FORMERLY:CURRENT;
6	What was the amount of the recreational product used?	Amount	Indicate the amount of recreational drug the subject consumes on a regular basis.	Text	SUDOSE; SUDOSTXT
7	SUDOSU	What was the unit?	Record the unit. See the protocol for a list of units.	Text	SUDOSU	SUDOSU	(UNIT)
8	SUDOSFRQ	What was the frequency of recreational product use?	Record how often the subject regularly uses the recreational product.	Text	SUDOSFRQ		(FREQ)	Occasionally; Intermittent; Daily; PRN; Unknown

This is the SDTM dataset used to represent the above collected data. The applicant populated SUPRESP="Y" for all substances specified in the drop-down list on the CRF. Other substances were not considered prespecified.

Row 1:	Shows that the subject was using cigarettes before the baseline visit and was expected to continue to use cigarettes after the baseline visit, The baseline visit occurred on 2006-01-01. This is represented using SUSTTPT, SUSTRTPT, SUENTPT and SUENRTPT. SUPRESP is used to indicate that the use of cigarettes was solicited on the CRF.
Row 2:	Shows the subject uses marijuana starting in 2002 and stopped using it on the day of the baseline visit. SUPRESP is used to indicate that the use of marijuana was solicited on the CRF.
Row 3:	Subject 1234006 is a former smoker. The date this subject began smoking is unknown, but it was sometime before the assessment date; this is shown by the values of SUSTTPT and SUSTRTPT. The end date of smoking was collected, so SUENTPT and SUENRTPT are not populated. Instead, the end date is in SUENDTC.
Row 4:	Shows the subjects had missing data for the usage of recreational products; this is indicated by SUSTAT = "NOT DONE". The reason is in SUREASND.

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Row	STUDYID	DOMAIN	USUBJID	SUSEQ	SUTRT	SUCAT	SUPRESP	SUSTAT	SUREASND	SUDOSE	SUDOSU	SUDOSFRQ	SUSTDTC	SUENDTC	SUSTRTPT	SUSTTPT	SUENRTPT	SUENTPT
1	1234	SU	1234005	1	CIGARETTES	RECREATIONAL PRODUCT	Y			2	PACK	QD			BEFORE	2006-01-01	ONGOING	2006-01-01
2	1234	SU	1234005	2	MARIJUNA	RECREATIONAL PRODUCT	Y						2002	2006-01-01
3	1234	SU	1234006	1	CIGARETTES	RECREATIONAL PRODUCT	Y			1	PACK	QD		2003	BEFORE	2006-03-15
4	1234	SU	1234007	1	RECREATIONAL PRODUCT	RECREATIONAL PRODUCT		NOT DONE	Subject left office before CRF was completed

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Example

This example illustrates how tobacco use history data could be collected. This example only includes tobacco products that are not being used as a medically acceptable therapy for smoke cessation. This includes cigarettes, cigars, pipes, chewing tobacco, snus or tobacco pouches, or tobacco dips. The specific brand name of the product was collected. The sponsor collected whether the product was still being used, and if not the end date of usage. Usage of these products are represented in the SU domain.

Section 1

Order	Question Text	Prompt	CRF Completion Instructions	Type	Collection Variable	Tabulation Target	Mapping Instuctions	Controlled Terminology Code List Name	Permissible Values	Pre-Populated Value
1	What is the object?			Text	FAOBJ	FAOBJ				TOBACCO
2	What was the age of the subject when they started smoking?	Age Started Smoking	Record the Age Category when the subject started smoking	Text	AGESTSMK__FAORRES	FAORRES	FAORRES WHERE FATESTCD = "AGESTSMK" and FAOBJ = "TOBACCO"		16-24 years; 25-34 years; 45–64 years; 65 years and older
3	Did the subject have any tobacco cessation counseling?	Tobacco Cessation Counseling	Indicate whether the subject had previous tobacco cessation counseling	Text	TBCESSCO__FAORRES	FAORRES	FAORRES WHERE FATESTCD = "TBCESSCO" and FAOBJ = "TOBACCO"	(NY)	No;Yes
4	What is the longest duration of previous abstinence from tobacco use?	Longest Duration of Abstinence	Record the longest duration of tobacco abstinence	Text	LDURABS__FAORRES	FAORRES	FAORRES WHERE FATESTCD = "LDURABS" and FAOBJ = "TOBACCO"		≤7 days; 8–28 days;1–6 months; >6 months

Section 2

Order	Question Text	Prompt	CRF Completion Instructions	Type	Collection Variable	Tabulation Target	Mapping Instuctions	Controlled Terminology Code List Name	Permissible Values
5	What is the type of tobacco product used by the subject?	Substance Use Category	Record the type of tobacco product used.	Text	SUCAT	SUCAT			SMOKED TOBACCO PRODUCT; SMOKELESS TOBACCO PRODUCT (e.g., CHEWING TOBACCO, SNUFF, DIP, SNUS, or DISSOLVABLE TOBACCO PRODUCT)
6	What was the brand name of the tobacco product?	Product Name	Record the brand name of the tobacco product used.	Text	SUTRT	SUTRT
7	Is this the subject's usual brand of tobacco product?	Substance Use Subcategory	Indicate if this is the subject's usual brand of tobacco product used	Text	SUSCAT	SUSCAT			USUAL BRAND; NOT USUAL BRAND
9	What was the duration of use of the tobacco product ?	Duration	Provide the duration for the product used	Text	SUCDUR	SUDUR
9	What was the unit of duration of use of the tobacco product?	Unit	Select the appropriate duration unit for the product used	Text	SUCDURU	SUDUR			DAYS; MONTHS; YEARS;
10	Is the tobacco use ongoing?	Ongoing	Record the product used as ongoing if the subject has not stopped taking the product used at the time of data collection. The end date should be left blank.	Text	SUONGO	SUENRF; SUENRTPT	SUENRF or SUENRTPT	(NY)	No;Yes
11	What was the end date?	End Date	Record the date the product used was stopped using this format (DD-MON-YYYY). If the subject has not stopped taking the product used leave this field blank.	Date	SUENDAT	SUENDTC

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Example

In this example, the sponsor collected information on previous medically recognized products used to reduce nicotine dependency. The sposnor only collected details on the last attempt to reduce nicotine dependency for each type of product used. CMTRT was selected from a pre-specified list. These products are represented in the Concomitant Medication (CM) domain.The sponsor assigned CMTRT to the name used in the pre-selected list.

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These example SDTM datasets represent the data collected on the above CRF.

Rows 1, 3, 7, 9:

Show whether the subject has used any medications to help with nicotine dependence. This was prespecified on the CRF, hence CMPRESP="Y". The applicant assigned CMTRT to "DRUG USED IN NICOTINE DEPENDENCE" which was the category name in an external dictionary.

Rows 2, 4, 5, 6, 8:

Show the various medications that were used by subjects. CMSCAT is used to indicate that these data are associated with the last attempted use. CMDUR is the collected duration of the product use. This is used only if collected on the CRF and not derived from start and end date/times. CMDUR is provided using ISO 8601 duration notation. CMPRESP is null since the specific medication used is not prespecified.

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Row	STUDYID	DOMAIN	USUBJID	CMSEQ	CMTRT	CMCAT	CMSCAT	CMPRESP	CMOCCUR	CMDTC	CMDUR
1	1234	CM	1234005	1	DRUG USED IN NICOTINE DEPENDENCE			Y	Y	2008-08-08
2	1234	CM	1234005	2	NICOTINE PATCH XYZ	NICOTINE REPLACEMENT THERAPY	LAST ATTEMPTED USE WITH THIS MEDICATION				P2M
3	1234	CM	1234006	1	DRUG USED IN NICOTINE DEPENDENCE			Y	Y	2008-11-12
4	1234	CM	1234006	2	NICOTINE GUM ABC	NICOTINE REPLACEMENT THERAPY	LAST ATTEMPTED USE WITH THIS MEDICATION				P3M
5	1234	CM	1234006	3	NICOTINE LOZENGES ABC	NICOTINE REPLACEMENT THERAPY	LAST ATTEMPTED USE WITH THIS MEDICATION				P2W
6	1234	CM	1234006	1	BUPROPION	DRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTS	LAST ATTEMPTED USE WITH THIS MEDICATION				P1M
7	1234	CM	1234007	2	DRUG USED IN NICOTINE DEPENDENCE			Y	Y	2008-06-12
8	1234	CM	1234007	3	VARENICLINE	DRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTS	LAST ATTEMPTED USE WITH THIS MEDICATION				P40D
9	1234	CM	1234012	1	DRUG USED IN NICOTINE DEPENDENCE			Y	N	2008-03-05

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FACM was used to represent the total number of times the subject attempted to reduce nicotine dependency using a medically acceptable product. Only subjects who had attempted to reduce nicotine dependence are included in the FACM dataset.

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Row	STUDYID	DOMAIN	USUBJID	FASEQ	FATESTCD	FATEST	FAOBJ	FACAT	FAORRES	FASTRESC	FADTC
1	1234	FA	1234005	1	TOTNUM	Total Number	DRUG USED IN NICOTINE DEPENDENCE	ATTEMPTS TO REDUCE NICOTINE DEPENDENCE	4	4	2008-08-08
2	1234	FA	1234006	1	TOTNUM	Total Number	DRUG USED IN NICOTINE DEPENDENCE	ATTEMPTS TO REDUCE NICOTINE DEPENDENCE	5	5	2008-11-12
3	1234	FA	1234007	1	TOTNUM	Total Number	DRUG USED IN NICOTINE DEPENDENCE	ATTEMPTS TO REDUCE NICOTINE DEPENDENCE	3	3	2008-06-12

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Example

This example is another example of data collected on the use of smoking cessation products. This examples illustrates the use of CMOCCUR and CMPRESP. The sponsor used

This example CRF has 2 sections: Questions in the first section focus on whether any smoking cessation product has been used, and the questions in the second section collect each individual product used. In order to save space, some of the permissible values are only shown in the metadata specifications.

Section 1

Order	Question Text	Prompt	Case Report Form Completion Instructions	Type	Collection Variable	Tabulation Target	Mapping Instructions	Controlled Terminology CodeList Name	Permissible Values	Pre-Populated Value
1	What is the category for the medication?	Concomitant Medication Category		Text	CMCAT					SMOKING CESSATION PRODUCT
2	Were any smoking cessation products taken?	Any Smoking Cessation Products Taken	Indicate if the subject took any smoking cessation products If yes, include the appropriate details where indicated on the CRF.	Text	CMOCCUR	CMOCCUR;		(NY)	No;Yes

Section 2 For each smoking cessation product. If multiple other products are used, create a row for each other product.

Order	Question Text	Prompt	Case Report Form Completion Instructions	Type	Collection Variable	Tabulation Target	Mapping Instructions	Controlled Terminology CodeList Name	Permissible Values
3	What was the smoking cessation product used?	Smoking Cessation Product	Select the smoking cessation product.	Text	CMTRT	CMTRT	CMTRT; CMPRESP; If CMTRT="OTHER" Then CMTRT and CMPRESP are NULL.		NICOTINE PATCH; NICOTINE GUM; NICOTINE LOZENGE; NICOTINE INHALER; VARENICLINE; BUPROPION; OTHER
4	Did the subject previously use the selected medication/product for smoking cessation?	Smoking Cessation Product Used	Indicate if the subject had used the selected smoking cessation product	Text	CMOCCUR	CMOCCUR		(NY)	No; Yes
5	What was the name of the other smoking cessation product used?	Smoking Cessation Product Other	Indicate the Other type of product previously used.	Text	CMTRTO	CMTRT
6	Was the smoking cessation product discontinued due to an adverse experience?	Reason Smoking Cessation Product Discontinued	Indicate if the product was discontinued due to an Adverse Experience	Text	CMRSDISC	CMRSDISC	If Yes then CMRSDISC = "ADVERSE EXPERIENCE"	(NY)	No:Yes:
7	What was the last date the product was used?	Last Date Smoking Cessation Product Used	Indicate the last date the product was used. If the product was used with the last 14 days, a complete date must be recorded. Otherwise, partial dates can be recorded.	Date	CMENDAT	CMENDTC

This is the SDTM date for the data collected above. In this example, the applicant only represented whether the product was used in the last 14 days. CMPRESP was populated by the applicant for all pre-specified products. Medication specified as "OTHER" were not considered prespecified.

Row 1:	Shows the subject reported they had not previously used any smoking cessation product ( CMOCCUR ="N") . CMPRESP was included to indicate that the use of smoking cessation product was specifically asked on the CRF.
Rows 2, 5, 8, 11, 14, 17:	Show the subject reported they had used a smoking cessation product (CMOCCUR ="Y") . CMPRESP was included to indicate that the use of a smoking cessation product was specifically asked on the CRF.
Rows 3, 6, 9, 12, 15, 18:	Show the subject reported they had not used nicotine patches (CMOCCUR is "N"). Note: that all other rows for the products not used are not show for simplicity CMPRESP is used to represent that this product was pre-specified.
Rows 4, 7, 10, 13, 16:	Shows the subject reported using the product specified in CMTRT. CMENDTC indicates the last day the product was used. CMPRESP is used to represent that this product was pre-specified. CMOCCUR is Y. Subject ABC-0006 discontinued BUPROPION for an adverse event.
Row 19:	Shows the subject used natural supplement ABC for smoking cessation. Since this product was not specified on the CRF, CMPRESP is null.

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Row	STUDYID	DOMAIN	USUBJID	CMSEQ	CMTRT	CMCAT	CMPRESP	CMOCCUR	CMRSDISC	CMDTC	CMENDTC
1	ABC	CM	ABC-0001	1	SMOKING CESSATION PRODUCT		Y	N		2020-01-05
2	ABC	CM	ABC-0002	1	SMOKING CESSATION PRODUCT		Y	Y		2020-02-15
3	ABC	CM	ABC-0002	2	NICOTINE PAtCH	SMOKING CESSATION PRODUCT	Y	N		2020-02-15
4	ABC	CM	ABC-0002	3	NICOTINE GUM	SMOKING CESSATION PRODUCT	Y	Y		2020-02-15	2020-02-02
5	ABC	CM	ABC-0003	1	SMOKING CESSATION PRODUCT		Y	Y		2020-04-15
6	ABC	CM	ABC-0003	2	NICOTINE PAtCH	SMOKING CESSATION PRODUCT	Y	N		2020-04-15
7	ABC	CM	ABC-0003	3	NICOTINE LOZENGE	SMOKING CESSATION PRODUCT	Y	Y		2020-04-15	2012
8	ABC	CM	ABC-0004	1	SMOKING CESSATION PRODUCT		Y	Y		2021-04-16
9	ABC	CM	ABC-0004	2	NICOTINE PAtCH	SMOKING CESSATION PRODUCT	Y	N		2020-04-16
10	ABC	CM	ABC-0004	3	NICOTINE INHALER	SMOKING CESSATION PRODUCT	Y	Y		2021-04-16	2021-01
11	ABC	CM	ABC-0005	1	SMOKING CESSATION PRODUCT		Y	Y		2020-09-24
12	ABC	CM	ABC-0005	2	NICOTINE PAtCH	SMOKING CESSATION PRODUCT	Y	N		2020-09-24
13	ABC	CM	ABC-0005	3	VARENICLINE	SMOKING CESSATION PRODUCT	Y	Y		2020-09-24	2020-08-07
14	ABC	CM	ABC-0006	1	SMOKING CESSATION PRODUCT		Y	Y		2021-04-16
15	ABC	CM	ABC-0002	2	NICOTINE PAtCH	SMOKING CESSATION PRODUCT	Y	N		2021-04-16
16	ABC	CM	ABC-0006	3	BUPROPION	SMOKING CESSATION PRODUCT	Y	Y	ADVERSE EVENT	2021-04-16	2020-01-09
17	ABC	CM	ABC-0007	1	SMOKING CESSATION PRODUCT		Y	Y		2020-07-10
18	ABC	CM	ABC-0002	2	NICOTINE PAtCH	SMOKING CESSATION PRODUCT	Y	N		2020-07-10
19	ABC	CM	ABC-0007	2	NATURAL SUPPLEMENT ABC	SMOKING CESSATION PRODUCT		Y		2020-07-10	2020-04-10

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Recreational Product Usage (including Tobacco Usage)