Title:	De-Identified Data from CTN-0094
Version:	1.0.6
Date:	2023-09-21
Description:	These are harmonized datasets produced as part of the Clinical Trials Network (CTN) protocol number 0094. This is a US National Institute of Drug Abuse (NIDA) funded project; to learn more go to https://ctnlibrary.org/protocol/ctn0094/. These are datasets which have the data harmonized from CTN-0027 (https://ctnlibrary.org/protocol/ctn0027/), CTN-0030 (https://ctnlibrary.org/protocol/ctn0030/), and CTN-0051 (https://ctnlibrary.org/protocol/ctn0051/).
License:	MIT + file LICENSE
Encoding:	UTF-8
Language:	en-US
LazyData:	true
Depends:	R (≥ 2.10)
Suggests:	broom, conflicted, DiagrammeR, dplyr, forcats, ggplot2, ggthemes, gt, haven, infer, janitor, knitr, kableExtra, magrittr, pkgdown, plyr, psych, purrr, rlang, rmarkdown, roxygen2, rUM, scales, stringr, table1, tibble, tidyr, tidyverse, testthat (≥ 3.0.0), vcdExtra, xfun
RoxygenNote:	7.2.3
VignetteBuilder:	knitr
Config/testthat/edition:	3
URL:	https://ctn-0094.github.io/public.ctn0094data/
BugReports:	https://github.com/CTN-0094/public.ctn0094data/issues
NeedsCompilation:	no
Packaged:	2023-09-29 19:01:59 UTC; gabrielodom
Author:	Raymond Balise [aut, cre], Gabriel Odom [aut], Anna Calderon [aut]
Maintainer:	Raymond Balise <balise@miami.edu>
Repository:	CRAN
Date/Publication:	2023-10-01 15:50:05 UTC

All drugs taken

Description

This is a record of both self-reported drug use and positive drug screening results. See the vignette Harmonization Information for more details.

Usage

data(all_drugs)

Format

A tibble with 307,523 rows and 4 variables:

who

Type:	integer
Description:	Patient ID

what

Type:	factor (First/Reference level = Acetaminophen)
Description:	Name of drug (or alcohol) from self-reported or drug screening
Levels:	Acetaminophen, Alcohol, Amphetamine, Antibiotic, Antidepressant, Antiemetic, Antihistamine, Antipsychotic, Barbiturate, Benadryl, Benzodiazepine, Buprenorphine, Caffeine, Cathinones, Clonidine, Cocaine, Codeine, Crack, Dextromethorphan, Fentanyl, Gabapentin, Ghb, Hallucinogen, Heavy Drinking, Heroin, Hydrocodone, Hydromorphone, Inhalant, K2, Kratom, Light Drinking, Mdma, Merperidine, Methadone, Methamphetamine, Methylphenidate, Morphine, Musclerelax, Nalbuphine, Opioid, Opium, Oxycodone, Oxymorphone, Pcp, Propoxyphene, Pseudoephedrine, Sedative-Hypnotic, Suboxone, Thc, Tramadol, Trazodone, Tryclic-Antidepressant, Unknown

source

Type:	factor (First/Reference level = TFB)
Description:	Source of reported drug use. TLFB = Timeline Follow Back; UDS = Urine Drug Screening; UDSAB = Urine Drug Screening & Alcohol Breathalyzer
Levels:	TFB, UDS, UDSAB

when

Type:	integer
Description:	Study day

Did patient use intravenous drugs

Description

IV drug use information from the Addiction Severity Index

Usage

data(asi)

Format

A tibble with 3,560 rows and 2 variables:

who

Type:	integer
Description:	Patient ID

used_iv

Type:	factor (First/Reference level = No)
Description:	Self-reported history of IV drug use
Levels:	No, Yes

Patient demographics

Description

This is baseline demographics. See the vignette Harmonization Information for more details.

Usage

demographics

Format

A tibble with 3,560 rows and 9 variables:

who

Type:	integer
Description:	Patient ID

age

Type:	integer
Description:	Age at intake

is_hispanic

Type:	factor (First/Reference level = No)
Description:	Hispanic heritage
Levels:	No; Yes

race

Type:	factor (First/Reference level = Black)
Description:	Self-reported race
Levels:	Black, Other Refused/missing, White

job

Type:	factor (First/Reference level = Full Time)
Description:	Employment status at intake
Levels:	"" = Not asked, "Full Time", "Missing" = Missing from intake data, "Part Time", "Student", "Unemployed"

is_living_stable

Type:	factor (First/Reference level = No)
Description:	Living stability
Levels:	No = Not a stable living condition; Yes = Has a stable living place

education

Type:	factor (First/Reference level = HS/GED)
Description:	Education level at intake
Levels:	"HS/GED" = High school graduate or GED, "Less than HS" = Less High school and no GED, "Missing", More than HS = "Some education beyond high school"

marital

Type:	factor (First/Reference level = Married or Partnered)
Description:	Marital status at intake
Levels:	"" = Not asked, "Married or Partnered", "Never married" "Not answered" = Not asked during at intake, "Separated/Divorced/Widowed"

is_male

Type:	factor (First/Reference level = No)
Description:	Sex (not gender)
Levels:	No = Not Male); Yes = Is male

Start and Stop of Detox

Description

This is the start and stop date for detox (if known).

Usage

data(detox)

Format

A tibble with 1,316 rows and 3 variables:

who

Type:	integer
Description:	Patient ID

what

Type:	factor (First/Reference level = admission)
Description:	Indicator for start or stop of detox
Levels:	admission, discharge

when

Type:	integer
Description:	Day of start or stop of detox

Everybody with any data

Description

This is a list of each person with their original study project.

Usage

data(everybody)

Format

A tibble with 3,560 rows and 2 variables:

who

Type:	integer
Description:	Patient ID

project

Type:	factor (First/Reference level = 27)
Description:	CTN project number
Levels:	27, 30, 51

Fagerstrom Test for Nicotine Dependence

Description

Information on the intensity of physical addiction to nicotine at baseline. See the vignette Harmonization Information for more details.

Usage

fagerstrom

Format

A tibble with 3,119 rows and 4 variables:

who

Type:	integer
Description:	Patient ID

is_smoker

Type:	factor
Description:	No = Is not a smoker, Yes = Is a smoker
Levels:	No, Yes

ftnd

Type:	factor
Description:	Fagerstrom Test For Nicotine Dependence Score 0-10
Levels:	0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10

per_day

Type:	factor
Description:	Cigarettes per day
Levels:	, 10 OR LESS, 11-20, 21-30, 31 OR MORE

First Survey Date

Description

This file contains the dates for the demographics survey in CTN-0027 and CTN-0030 and the medical-psychiatric history for CTN-0051.

Usage

data(first_survey)

Format

A tibble with 3,453 rows and 2 variables:

who

Type:	integer
Description:	Patient ID

when

Type:	integer
Description:	Study day

Metadata About Study Length

Description

This is information on the duration of CTN-0094 trial periods.

Usage

data(meta_study_length)

Format

A tibble with 16 rows and 6 variables:

project

Type:	factor (First/Reference level = 27)
Description:	CTN project number
Levels:	27, 30, 51

treatment

Type:	factor (First/Reference level = Inpatient BUP)
Description:	ctn_0027: Methadone Outpatient BUP ctn_0030: Outpatient BUP + EMM Outpatient BUP + SMM ctn_0051: Outpatient BUP + EMM Outpatient BUP + SMM
Levels:	Inpatient BUP, Inpatient NR-NTX, Methadone, Outpatient BUP, Outpatient BUP + EMM, Outpatient BUP + SMM

phase

Type:	factor (First/Reference level = 1)
Description:	Study phase (needed because of CTN 30)
Levels:	1, 2

stage

Type:	factor (First/Reference level = 1)
Description:	Treatment stage used with description to capture different treatment phase/stage/period
Levels:	1, 2, 3

weeks

Type:	integer
Description:	Treatment duration in weeks

description

Type:	factor (First/Reference level = Buprenorphine-naloxone stabilization)
Description:	Description of the treatment duration
Levels:	Buprenorphine-naloxone stabilization, Buprenorphine-naloxone treatment, Post-medication follow-up, Taper, Treatment

Metadata About UDS Groupings

Description

A table of the substances assessed in three clinical trials via urine drug screen (UDS) and their groupings.

Usage

data(meta_substance_groups_uds)

Format

A tibble with 13 rows and 4 variables:

Substance

Type:	factor (First/Reference level = Alcohol)
Description:	substances screened by UDS per study; names drawn from trial case report forms
Levels:	Alcohol, Amphetamine, Barbiturate, Benzodiazepine, Buprenorphine, Cannabinoids, Cocaine, Methadone, Methamphetamine, Opiate 2000, Opiate 300, Oxycodone, Propoxyphene

CTN-0027

Type:	factor (First/Reference level = Alcohol)
Description:	Derived label used to group substances of interest, or "NO" if the substance was not screened for in ctn_0027
Levels:	Alcohol, Amphetamine, Benzodiazepine, Cocaine, Methadone, NO, Opioid, THC

CTN-0030

Type:	factor (First/Reference level = Amphetamine)
Description:	Derived label used to group substances of interest, or "NO" if the substance was not screened for in ctn_0030
Levels:	Amphetamine, Benzodiazepine, Buprenorphine, Cocaine, Methadone, NO, Opioid, THC

CTN-0051

Type:	factor (First/Reference level = Amphetamine)
Description:	Derived label used to group substances of interest, or "NO" if the substance was not screened for in ctn_0051
Levels:	Amphetamine, Barbiturate, Benzodiazepine, Buprenorphine, Cocaine, Methadone, NO, Opioid, THC

Details

This table indicates which substances were screened in each trial. The first column (substance) is drawn from labels which appear in case report forms for the three clinical trials. The remaining three columns hold "NO" if a substance was not screened in that trial, or a grouping label indicating what type of drug was screened. The ungrouped data can be found in all_drugs.

For example, "Opiate 300 ng" and "Oxycodone" are assigned to the grouping label "Opioid", and they were assessed in each clinical trial (so none of the rows show "NO"). In contrast, while "Opiate 2000 ng" is also assigned to the grouping label "Opioid", it was neither assessed in ctn_0027 nor ctn_0030; thus, the grouping label is "NO" for these trials. For more details, see the Harmonization Information vignette.

Self-Reported Pain

Description

This is self-reported pain from the SF-36 (ctn_0027 and ctn_0030) and EuroQoL (ctn_0051). See the Harmonization Information vignette for more details.

Usage

data(pain)

Format

A tibble with 3,082 rows and 3 variables:

who

Type:	integer
Description:	Patient ID

pain

Type:	factor (First/Reference level = Missing)
Description:	Pain severity
Levels:	Missing, No Pain, Severe Pain, Very mild to Moderate Pain

when

Type:	integer
Description:	Study day

Psychiatric History

Description

Information on psychiatric symptoms and diagnoses. The same constructs were measured using different instruments. For example, the Addition Severity Index (ASI) asks "Have you had a significant period of time (that was not a direct result of drug/alcohol use) in which you have experienced hallucinations - saw things or heard voices that other people did not hear or see?" and the medical and psychiatric history evaluation asks about schizophrenia. The definitions of substance abuse have changed in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders. Also see the Harmonization Information vignette for more details.

Usage

data(psychiatric)

Format

A tibble with 3,560 rows and 16 variables:

who

Type:	integer
Description:	Patient ID

has_schizophrenia

Type:	factor (First/Reference level = No)
Description:	Medical and psychiatric history interview indicates schizophrenia
Levels:	No, Yes

has_major_dep

Type:	factor (First/Reference level = No)
Description:	Medical and psychiatric history interview indicates major depression
Levels:	No, Yes

has_bipolar

Type:	factor (First/Reference level = No)
Description:	Medical and psychiatric history interview indicates bipolar disorder
Levels:	No, Yes

has_anx_pan

Type:	factor (First/Reference level = No)
Description:	Medical and psychiatric history interview indicates anxiety panic disorder
Levels:	No, Yes

has_brain_damage

Type:	factor (First/Reference level = No)
Description:	Medical and psychiatric history interview indicates brain damage
Levels:	No, Yes

has_epilepsy

Type:	factor (First/Reference level = No)
Description:	Medical and psychiatric history interview indicates epilepsy
Levels:	No, Yes

depression

Type:	factor (First/Reference level = Yes)
Description:	Addiction Severity Index-Lite Follow-up depression: P4 = "Experienced serious depression-sadness, hopelessness, loss of interest, difficulty with daily function?" See the Details section below
Levels:	Yes, No, Not answered, Missing,

anxiety

Type:	factor (First/Reference level = Yes)
Description:	Addiction Severity Index-Lite Follow-up anxiety: P5 = "Experienced serious anxiety/tension, uptight, unreasonably worried, inability to feel relaxed?" See the Details section below
Levels:	Yes, No, Not answered, Missing,

schizophrenia

Type:	factor (First/Reference level = Yes)
Description:	Addiction Severity Index-Lite Follow-up schizophrenia P6 = "Experienced hallucinations -- saw things or heard voices that other people did not hear or see?" See the Details section below
Levels:	Yes, No, Not answered, Missing,

has_opiates_dx

Type:	factor (First/Reference level = No)
Description:	DSM-4 opioid abuse or dependence diagnosis or DSM-5 "opioid use disorder" (OUD) diagnosis
Levels:	No, Yes

has_alcol_dx

Type:	factor (First/Reference level = No)
Description:	DSM-4 alcohol abuse or dependence diagnosis or DSM-5 "alcohol use disorder" (AUD) diagnosis
Levels:	No, Yes

has_amphetamines_dx

Type:	factor (First/Reference level = No)
Description:	DSM-4 amphetamine and similar sympathomimetics abuse or dependence diagnosis or DSM-5 amphetamine-type substance use disorder
Levels:	No, Yes

has_cannabis_dx

Type:	factor (First/Reference level = No)
Description:	DSM-4 cannabis abuse or dependence diagnosis or DSM-5 cannabis use disorder
Levels:	No, Yes

has_cocaine_dx

Type:	factor (First/Reference level = No)
Description:	DSM-4 cocaine abuse or dependence diagnosis or DSM-5 cocaine use disorder
Levels:	No, Yes

has_sedatives_dx

Type:	factor (First/Reference level = No)
Description:	DSM-4 sedatives abuse or dependence diagnosis or DSM-5 sedative hypnotic/anxiolytic use disorder
Levels:	No, Yes

Details

Note that the data from the ASI (depression, anxiety, and schizophrenia) contains four levels plus NA. People who did not take the ASI are coded with NA. People who took the ASI but are completely missing an answer to a question are coded as "Missing". Others who are known to not answer (i.e., refused to answer) are coded with "Not Answered".

Source

DSM-IV: Diagnostic and Statistical Manual of Mental Disorders, JAMA. 1994;272(10):828-829. doi:10.1001/jama.1994.03520100096046

Diagnostic and Statistical Manual of Mental Disorders (Fifth ed.). Arlington, VA: American Psychiatric Publishing. ISBN 978-0-89042-555-8.

Quality of Life

Description

This is quality of life data from the PhenX Quality of Life survey (see https://www.phenxtoolkit.org/protocols/view/221302). This was used by the Clinical Trials Network protocol CTN-0051.

Usage

data(qol)

Format

A tibble with 657 rows and 2 variables:

who

Type:	integer
Description:	Patient ID

is_homeless

Type:	factor (First/Reference level = No)
Description:	Are you currently homeless or living in a shelter?
Levels:	No, Yes

Randomization Data

Description

This is the information on the treatment group. Note that CTN30 had two randomization events.

Usage

data(randomization)

Format

A tibble with 4,691 rows and 4 variables:

who

Type:	integer
Description:	Patient ID

treatment

Type:	factor (First/Reference level = Inpatient BUP)
Description:	What treatment is prescribed?
Levels:	Inpatient BUP, Inpatient NR-NTX, Methadone, Outpatient BUP, Outpatient BUP + EMM, Outpatient BUP + SMM

which

Type:	factor (First/Reference level = 1)
Description:	Indicator of which randomization. Needed because CTN 30 has two randomization dates.
Levels:	1, 2

when

Type:	integer
Description:	Study day

Risk Behavior Survey

Description

This is the drug use information on from the RBS. Questions ask, "How many days did you use ___ in the last 30 days?" Days were categorized in ctn_0051. See the Harmonization Information vignette for more details.

Usage

data(rbs)

Format

A tibble with 15,410 rows and 4 variables:

who

Type:	integer
Description:	Patient ID

what

Type:	factor (First/Reference level = cocaine)
Description:	What drug was used: "cocaine" = Cocaine by itself "heroin" = Heroin by itself "opioid" = Have you ever used Other Opiates "speed" = Have you ever used Amphetamines (Speed, Methamphetamine, Crank) "speedball" = Heroin and cocaine mixed
Levels:	cocaine, heroin, opioid, speed, speedball

did_use

Type:	factor (First/Reference level = No)
Description:	Is there a self-reported history of use?
Levels:	No, Yes

days

Type:	integer
Description:	Number of days out of 30 that the drug was used

Risk Behavior Survey IV drug use information

Description

This is aggregated data in IV drug use. See the Harmonization Information vignette for more details.

Usage

data(rbs_iv)

Format

A tibble with 3,560 rows and 10 variables:

who

Type:	integer
Description:	Patient ID

days

Type:	integer
Description:	Maximum number of days of IV drug use across all injected drug

max

Type:	integer
Description:	Number of drug use events

amount

Type:	integer
Description:	Indicator of total IV drug exposure for the most used IV drug

shared

Type:	factor (First/Reference level = No)
Description:	Did you share needles in the last 30 days?
Levels:	No, Yes

cocaine_inject_days

Type:	integer
Description:	Number of days out of last 30 when cocaine was injected

heroin_inject_days

Type:	integer
Description:	Number of days out of last 30 when heroin was injected

speedball_inject_days

Type:	integer
Description:	Number of days out of last 30 when speedball was injected

opioid_inject_days

Type:	integer
Description:	Number of days out of last 30 when opioid was injected

speed_inject_days

Type:	integer
Description:	Number of days out of last 30 when speed was injected

Screening Date Information

Description

The information on the screening data and baseline drug screening data is complex and inconsistent across studies. This file has information on dates around the screening visit and baseline timeline follow back assessments.

Usage

data(screening_date)

Format

A tibble with 3,430 rows and 3 variables:

who

Type:	integer
Description:	Patient ID

screening_day

Type:	integer
Description:	The day of screening

day_zero

Type:	integer
Description:	Best guess at the end of TLFB

Sexual Activity in Risk Behavior Survey

Description

Information on sexual activities from the (RBS)

Usage

data(sex)

Format

A tibble with 3,299 rows and 40 variables:

who

Type:	integer
Description:	Patient ID

txx_prt

Type:	factor (First/Reference level = 0)
Description:	Total sex partners: 0 = 0 1 = 1 2 = more than one
Levels:	0, 1, 2

txx_mprt

Type:	factor (First/Reference level = 0)
Description:	Total male sex partners: 0 = 0 1 = 1 2 = more than one
Levels:	0, 1, 2

txx_fprt

Type:	factor (First/Reference level = 0)
Description:	Total female sex partners: 0 = 0 1 = 1 2 = more than one
Levels:	0, 1, 2

msw_npt

Type:	factor (First/Reference level = 0)
Description:	Men who have sex with women (MSW), sex partners: 0 = 0 1 = 1 2 = more than one
Levels:	0, 1, 2

msw_frq

Type:	integer
Description:	MSW count of sex

msw_pxx

Type:	integer
Description:	MSW count of protected (with condom use) sex

msw_uxx

Type:	integer
Description:	MSW count of unprotected sex

msm_npt

Type:	factor (First/Reference level = 0)
Description:	Men have sex with men (MSM), sex partners: 0 = 0 1 = 1 2 = more than one
Levels:	0, 1, 2

msm_frq

Type:	integer
Description:	MSM count of sex

msm_pxx

Type:	integer
Description:	MSM count of protected (with condom use) sex

msm_uxx

Type:	integer
Description:	MSM count of unprotected sex

wsm_npt

Type:	factor (First/Reference level = 0)
Description:	Women have sex with men (WSM), sex partners: 0 = 0 1 = 1 2 = more than one
Levels:	0, 1, 2

wsm_frq

Type:	integer
Description:	WSM count of sex

wsm_pxx

Type:	integer
Description:	WSM count of protected (with condom use) sex

wsm_uxx

Type:	integer
Description:	WSM count of unprotected sex

txx_frq

Type:	integer
Description:	TOTAL count of sex

txx_pxx

Type:	integer
Description:	TOTAL count of protected (with condom use) sex

txx_uxx

Type:	integer
Description:	TOTAL count of unprotected sex

mvw_frq

Type:	integer
Description:	Men vaginal sex with women count of sex

maw_frq

Type:	integer
Description:	Men anal sex with women count of sex

mim_frq

Type:	integer
Description:	Men insertive sex with men count of sex

mrm_frq

Type:	integer
Description:	Men receptive sex with men count of sex

wvm_frq

Type:	integer
Description:	Women vaginal sex with men count of sex

wam_frq

Type:	integer
Description:	Women anal sex with men count of sex

mvw_pxx

Type:	integer
Description:	Men vaginal sex with women count of protected sex

maw_pxx

Type:	integer
Description:	Men anal sex with women count of protected sex

mim_pxx

Type:	integer
Description:	Men insertive sex with men count of protected sex

mrm_pxx

Type:	integer
Description:	Men receptive sex with men count of protected sex

wvm_pxx

Type:	integer
Description:	Women vaginal sex with men count of protected sex

wam_pxx

Type:	integer
Description:	Women anal sex with men count of protected sex

mvw_uxx

Type:	integer
Description:	Men vaginal sex with women count of unprotected sex

maw_uxx

Type:	integer
Description:	Men anal sex with women count of unprotected sex

mim_uxx

Type:	integer
Description:	Men insertive sex with men count of unprotected sex

mrm_uxx

Type:	integer
Description:	Men receptive sex with men count of unprotected sex

wvm_uxx

Type:	integer
Description:	Women vaginal sex with men count of unprotected sex

wam_uxx

Type:	integer
Description:	Women anal sex with men count of unprotected sex

t_p

Type:	integer
Description:	Total count of sex partners

t_fp

Type:	integer
Description:	Total count of female sex partners

t_mp

Type:	integer
Description:	Total count of male sex partners

Site Regrouped

Description

This is study site (clinic/research site number) information. Large study sites were split into smaller groups and small study site were grouped into larger sites. The regrouped study sites are each approximately 100 subjects. This was done to protect the anonymity of the study sites.

Usage

data(site_masked)

Format

A tibble with 3,560 rows and 2 variables:

who

Type:	integer
Description:	Patient ID

site_masked

Type:	factor (First/Reference level = 2)
Description:	Study Site Regrouped
Levels:	2, 5, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36

Timeline Followback (TLFB) Drug Use Information

Description

This is self-reported drug use. The values are the result of extensive processing of free text as well as structured values. These substances are group grouped as opioids: Codeine, Fentanyl, Hydrocodone, Merperidine, Oxycodone, Oxymorphone, Propoxyphene. NOTE: Records where people self-reported the study drug after it was prescribed have been removed from this file. The all_drugs dataset contains these nebulous records. See the vignette Harmonization Information for more information.

Usage

data(tlfb)

Format

A tibble with 237,778 rows and 3 variables:

who

Type:	integer
Description:	Patient ID

what

Type:	factor (First/Reference level = Alcohol)
Description:	Text description of drugs; for more information, see Harmonization Information
Levels:	Alcohol, Amphetamine, Analgesic, Antibiotic, Antidepressant, Antiemetic, Antihistamine, Antipsychotic, Benadryl, Benzodiazepine, Buprenorphine, Caffeine, Cathinones, Clonidine, Cocaine, Dextromethorphan, Ghb, Hallucinogen, Heroin, Inhalant, K2, Kratom, Mdma/Hallucinogen, Methadone, Methylphenidate, Muscle Relaxant, Opioid, Pcp, Pseudoephedrine, Sedatives, THC, Unknown

when

Type:	integer
Description:	Study Day

Amount of Study Drug Per Day

Description

The doses (usually in milligrams) of the study drug administered to each subject by day. When the study drug is listed as an injection, then the amount is recorded as 1.

Usage

data(treatment)

Format

A tibble with 216,242 rows and 3 variables:

who

Type:	integer
Description:	Patient ID

amount

Type:	integer
Description:	The amount of drugs received on a day. Value is 1 for injections and mg otherwise

when

Type:	integer
Description:	Study day

Urine Drug Screening (UDS) Results

Description

UDS findings. Note that oxycodone and propoxyphene are grouped into the opioid category. ctn_0051 did not specifically screen for propoxyphene. For details on substances screened, see the vignette Harmonization Information.

Usage

data(uds)

Format

A tibble with 42,906 rows and 3 variables:

who

Type:	integer
Description:	Patient ID

what

Type:	factor (First/Reference level = Alcohol)
Description:	Name of drug identified
Levels:	Alcohol, Amphetamine, Benzodiazepine, Buprenorphine, Cocaine, Mdma/Hallucinogen, Methadone, Opioid, Sedatives, Thc

when

Type:	integer
Description:	Study day

Urine Drug Screening (UDS) Temperature

Description

This is information on whether the urine temperature was in the acceptable range.

Usage

data(uds_temp)

Format

A tibble with 36,680 rows and 3 variables:

who

Type:	integer
Description:	Patient ID

was_temp_ok

Type:	factor (First/Reference level = 0)
Description:	was the temperature 92°F \le X \le 96°F OR 33.3°C \le X \le 35.5°C? 0 = "No", 1 = "Yes", 99 = "Unknown"
Levels:	0, 1, 99

when

Type:	integer
Description:	Study day

Patient Visit Data

Description

This contains planned visits. Not all appointments were kept. Indicator variables show reasons for a missed appointment (if known). This data is not simple. There are more than 1300+ dates duplicated with different visit types. There are week 24 visits that happen at the wrong time (e.g., the date of week 24 is the same as week 8). There are also many cases where two adjacent visits happen on the same day (e.g., both week 7 and week 8 have their visits on the same day). There are both visit and no visit reports on the same day for some people. There are nearly 850 “Cross Active Study” visits and all but 43 happen on the same date as another visit. Many variables have a "1" indicating "Yes". Other are NA because we don't know if those values are real "No" or actually "Unknown". Proceed with great caution.

Usage

data(visit)

Format

A tibble with 53,899 rows and 19 variables:

who

Type:	integer
Description:	Patient ID

visit

Type:	factor (First/Reference level = BASELINE)
Description:	Indicator of the visit type. For example, "WK12" is week 12 of ctn_0027 or "P2Wk13" is week 13 of phase 2 of ctn_0030. See the table above.
Levels:	BASELINE, Cross Active Study, EOT, M1F, M3F, P1Finl, P1Unsc, P1Wk10, P1Wk12, P1Wk1A, P1Wk1B, P1Wk2, P1Wk3, P1Wk4, P1Wk6, P1Wk8, P2Finl, P2Unsc, P2Wk10, P2Wk11, P2Wk12, P2Wk13, P2Wk14, P2Wk15, P2Wk16, P2Wk18, P2Wk1A, P2Wk1B, P2Wk2, P2Wk20, P2Wk22, P2Wk24, P2Wk3, P2Wk4, P2Wk5, P2Wk6, P2Wk7, P2Wk8, P2Wk9, WK0, WK1, WK10, WK11, WK12, WK13, WK14, WK15, WK16, WK17, WK18, WK19, WK2, WK20, WK21, WK22, WK23, WK24, WK28, WK3, WK32, WK4, WK5, WK6, WK7, WK8, WK9

what

Type:	factor (First/Reference level = )
Description:	Disposition of appointment - visit, no visit or MISSING. Note there are records with no disposition
Levels:	, final, MISSING, no visit, visit

is_no_note

Type:	factor (First/Reference level = 1)
Description:	UNKNOWN
Levels:	1

is_dead

Type:	factor (First/Reference level = 1)
Description:	Patient died
Levels:	1

is_no_show

Type:	factor (First/Reference level = 1)
Description:	Patient did not show with no explanation
Levels:	1

is_no_funding

Type:	factor (First/Reference level = 1)
Description:	Patient could not afford to get to appointment
Levels:	1

is_left_study

Type:	factor (First/Reference level = 1)
Description:	Patient withdrew from the study
Levels:	1

is_in_jail

Type:	factor (First/Reference level = 1)
Description:	Patient is incarcerated
Levels:	1

is_forgot

Type:	factor (First/Reference level = 1)
Description:	Patient forgot appointment
Levels:	1

is_in_hospital

Type:	factor (First/Reference level = 1)
Description:	Patient hospitalized during appointment
Levels:	1

is_illness

Type:	factor (First/Reference level = 1)
Description:	Patient reported being to sick to attend
Levels:	1

is_moved

Type:	factor (First/Reference level = 1)
Description:	Patient moved from the study area
Levels:	1

is_missing_14_consecutive

Type:	factor (First/Reference level = 1)
Description:	Patient dropped for non-compliance
Levels:	1

is_window

Type:	factor (First/Reference level = 1)
Description:	UNKNOWN
Levels:	1

is_unable

Type:	factor (First/Reference level = 1)
Description:	Patient reports being unable to attend
Levels:	1

is_on_vacation

Type:	factor (First/Reference level = 1)
Description:	Patient reports being on vacation
Levels:	1

is_other

Type:	factor (First/Reference level = 1)
Description:	Other reason given
Levels:	1

when

Type:	integer
Description:	Study day

Patient Withdrawal Symptoms Per Day

Description

CTN 27 and 30 use the Clinical Opiate Withdrawal Scale (COWS). CTN 51 uses SOWS. See harmonization vignette for more details.

Usage

data(withdrawal)

Format

A tibble with 14,983 rows and 3 variables:

who

Type:	integer
Description:	Patient ID

withdrawal

Type:	factor (First/Reference level = 0)
Description:	0 = "None" 1 = "mild" 2 = "moderate" 3 = "severe"
Levels:	0, 1, 2, 3

when

Type:	integer
Description:	Study day

Source

Clinical Opiate Withdrawal Scale (COWS) Wesson, DR, & Ling, W. (2003)

Subjective Opiate Withdrawal Scale (SOWS) Handelsman L, Cochrane KJ, Aronson MJ, Ness R, Rubinstein KJ, Kanof, PD (1987). Two New Rating Scales for Opiate Withdrawal. The American journal of drug and alcohol abuse, 1987, Vol.13 (3), p.293-308

Patient Withdrawal Symptoms Pre and Post Induction

Description

This is a information on the severity of withdrawal symptoms.

Usage

data(withdrawal_pre_post)

Format

A tibble with 4,805 rows and 4 variables:

who

Type:	integer
Description:	Patient ID

what

Type:	factor (First/Reference level = post)
Description:	Indicator of induction day type: "pre" or "post"
Levels:	post, pre

withdrawal

Type:	factor (First/Reference level = 0)
Description:	0 = "None" 1 = "mild" 2 = "moderate" 3 = "severe"
Levels:	0, 1, 2, 3

when

Type:	integer
Description:	Day of assessment