Protocol Overview

February 6, 2009

The Expert Review Panel has not reviewed this measure yet.

Measurement of respondent’s lifetime use of illicit and prescribed substances.

Respondents will answer yes or no to the following list of drugs. If he or she indicates that he or she has used a specific drug (even experimentally), the interviewer will query for the specific drug(s) used. Note that the protocol specified below has been adapted so that the names of the drug categories are listed as noted in Wave 2 of the National Epidemiologic Survey on Alcohol and Related Conditions (NESARC) survey (see Source below). In Wave 1, each drug category was phonetically spelled out for the interviewer.

The Working Group acknowledges that the following questions may gather sensitive information relating to the use of substances and/or illegal conduct. If the information is released it might be damaging to an individual’s employability, lead to social stigmatization, or other consequences.

For information on obtaining a Certificate of Confidentiality, which helps researchers protect the privacy of human research participants, please go to the National Human Genome Research Institute’s Institutional Review Board website.

The following questions are asked of the respondent. First read the introductory paragraph to the respondent. Show the respondent the flashcard (provided below) and read to the respondent the list of drug categories (items 1-10). If the respondent answers "Yes" to any drug category, ask Which ones? Record the specific drug(s) used.

Now I’d like to ask you about your experiences with medicines and other kinds of drugs that you may have used ON YOUR OWN - that is, either WITHOUT a doctor’s prescription (PAUSE); in GREATER amounts, MORE OFTEN, or LONGER than prescribed (PAUSE); or for a reason other than a doctor said you should use them. People use these medicines and drugs ON THEIR OWN to feel more alert, to relax or quiet their nerves, to feel better, to enjoy themselves, or to get high or just to see how they would work.

Have you EVER used any of these medicines or drugs?

         [ ] 1 Sedatives, for example, sleeping pills, barbiturates, Seconal®, Quaaludes, or Chloral Hydrate - Specify ↓

________________________________________________________________________________________________

         [ ] 2 Tranquilizers or anti-anxiety drugs, for example, Valium®, Librium®, muscle relaxants, or Zanax® - Specify ↓

________________________________________________________________________________________________

         [ ] 3 Painkillers, for example, Codeine, Darvon®, Percodan®, OxyContin®, Dilaudid®, Demerol®, Celebrex®, or Vioxx® - Specify ↓

________________________________________________________________________________________________

         [ ] 4 Stimulants, for example, Preludin®, Benzedrine®, Methedrine®, Ritalin®, uppers, or speed - Specify ↓

________________________________________________________________________________________________

         [ ] 5 Marijuana, hash, THC, or grass - Specify ↓

________________________________________________________________________________________________

         [ ] 6 Cocaine or crack - Specify ↓

________________________________________________________________________________________________

         [ ] 7 Hallucinogens, for example, Ecstasy/MDMA, LSD, mescaline, psilocybin, PCP, angel dust, or peyote - Specify ↓

________________________________________________________________________________________________

         [ ] 8 Inhalants or solvents, for example, amyl nitrite, nitrous oxide, glue, toluene or gasoline - Specify ↓

________________________________________________________________________________________________

         [ ] 9 Heroin

________________________________________________________________________________________________

         [ ] 10 Any OTHER medicines, or drugs, or substances, for example, methadone, Elavil®, steroids, Thorazine®, or Haldol®? - (SELECT MOST FREQUENTLY USED OTHER DRUG)

________________________________________________________________________________________________

The following supplemental flashcard has been revised from the original to reflect the ten drug categories listed in the Alcohol Use Disorder and Associated Disabilities Interview Schedule Fourth Edition Version (AUDADIS-IV) instrument.*

1.       Sedatives, for example, sleeping pills, barbiturates, Seconal®, Quaaludes®, or Chloral Hydrate®

2.       Tranquilizers or anti-anxiety drugs, for example, Valium®, Librium®, muscle relaxants, or Zanax®

3.       Painkillers, for example, Codeine, Darvon®, Percodan®, Dilaudid®, or Demerol®

4.       Stimulants, for example, Preludin®, Benzedrine®, Methadrine®, uppers, or speed

5.       Marijuana, hash, THC, or grass

6.       Cocaine or crack

7.       Hallucinogens, for example, Ecstasy, LSD, mescaline, psilocybin, PCP, angel dust, or peyote

8.       Inhalants or Solvents, for example, amyl nitrate, nitrous oxide, glue, tolune, or gasoline

9.       Heroin

10.       Any OTHER medicines, drugs, or substances, for example, Methadone®, Elavi®l, steroids, Thorazine®, or Haldol®

* The original Wave 1 National Epidemiologic Survey on Alcohol and Related Conditions (NESARC) instrument had ten categories for the lifetime substance use question: Categories 1-8 listed above, along with two additional slots where the respondent could name one of the "other" drugs (including heroin). While editing the data from the Wave 1 responses, the National Institute on Alcohol Abuse and Alcoholism (NIAAA) determined a single category for heroin would be appropriate, leaving only one field for coding "other" drugs. The Alcohol Use Disorder and Associated Disabilities Interview Schedule Fourth Edition Version (AUDADIS - IV) was modified to create a separate category 9 for heroin and a category 10 for other drugs and edited the AUDADIS questionnaire to reflect this change.

Seconal® a registered trademark, Eli Lilly and Company; Valium® a registered trademark, Hoffman LaRoche Inc.; Librium® a registered trademark, Valeant Pharmaceuticals International; Zanax® a registered trademark, UpJohn Company; Darvon® a registered trademark, Eli Lilly and Company; Percodan® a registered trademark, ENDO Pharmaceuticals, Inc.; OxyContin® a registered trademark, Purdue Pharma, LP; Dilaudid® a registered trademark, Purdue Pharma, LP; Demerol® a registered trademark, Sanofi-Aventis Group; Celebrex® a registered trademark, G.D. Searle & Co.; Vioxx® a registered trademark, Merck & Co., Inc.; Preludin® a registered trademark, Boehringer-Ingelheim; Benzedrine® a registered trademark, GlaxoSmithKline; Methedrine® a registered trademark, GlaxoSmithKline; Ritalin® a registered trademark, Novartis Pharmaceuticals Corp.; Elavil® a registered trademark, Astra Zeneca Pharmaceuticals., Inc; Thorazine® a registered trademark, GlaxoSmithKline; Haldol® a registered trademark, Ortho-McNeil Pharmaceutical, Inc.

Export Variables

Variable Name	Variable ID	Variable Description	Version	Mapping
PX031101_Lifetime_Use_Sedatives	PX031101010000	Have you EVER used any of these medicines or drugs? Sedatives, for example, sleeping pills, barbiturates, Seconal, Quaaludes, or Chloral Hydrate - Specify	4	Variable Mapping
PX031101_Lifetime_Use_Tranquilizers	PX031101020000	Have you EVER used any of these medicines or drugs? Tranquilizers or anti-anxiety drugs, for example, Valium, Librium, muscle relaxants, or Zanax- Specify	4	Variable Mapping
PX031101_Lifetime_Use_Painkillers	PX031101030000	Have you EVER used any of these medicines or drugs? Painkillers, for example, Codeine, Darvon, Percodan, Oxycontin, Dilaudid, Demerol, Celebrex® Vioxx - Specify	4	Variable Mapping
PX031101_Lifetime_Use_Stimulants	PX031101040000	Have you EVER used any of these medicines or drugs? Stimulants, for example, Preludin, Benzedrine, Methedrine, Ritalin, uppers, or speed - Specify	4	Variable Mapping
PX031101_Lifetime_Use_Marijuana	PX031101050000	Have you EVER used any of these medicines or drugs? Marijuana, hash, THC, or grass - Specify	4	Variable Mapping
PX031101_Lifetime_Use_Cocaine	PX031101060000	Have you EVER used any of these medicines or drugs? Cocaine or crack - Specify	4	Variable Mapping
PX031101_Lifetime_Use_Hallucinogens	PX031101070000	Have you EVER used any of these medicines or drugs? Hallucinogens, for example, Ecstasy/MDMA, LSD, mescaline, psilocybin, PCP, angel dust, or peyote - Specify	4	Variable Mapping
PX031101_Lifetime_Use_Inhalant	PX031101080000	Have you EVER used any of these medicines or drugs? Inhalants or solvents, for example, amyl nitrite, nitrous oxide, glue, toluene or gasoline - Specify	4	Variable Mapping
PX031101_Lifetime_Use_Heroin	PX031101090000	Have you EVER used any of these medicines or drugs? Heroin	4	Variable Mapping
PX031101_Lifetime_Use_Other	PX031101100000	Have you EVER used any of these medicines or drugs? Any OTHER medicines, or drugs, or substances, for example, methadone, Elavil, steroids, Thorazine or Haldol? - (SELECT MOST FREQUENTLY USED OTHER DRUG)	4	Variable Mapping

The protocol from the Alcohol Use Disorder and Associated Disabilities Interview Schedule (AUDADIS) was chosen because it was used in a large epidemiological study containing adults with a wide age range and different ethnicities (Wave 1 included 43,093 Americans; in Wave 2, 34,653 members of the original cohort were reinterviewed). The measures from this survey have been validated and psychometrically tested.

National Institute on Alcohol Abuse and Alcoholism (NIAAA) National Epidemiologic Survey on Alcohol and Related Conditions. Wave 1 (NESARC - WAVE 1). Alcohol Use Disorder and Associated Disabilities Interview Schedule - Diagnostic and Statistical Manual of Mental Disorders. Fourth Edition Version (AUDADIS-IV), Section 3B (question 1a).

Grant, B. F., Dawson, D. A., Stinson, F. S., Chou, P. S., Kay, W., & Pickering, R. (2003). The Alcohol Use Disorder and Associated Disabilities Interview Schedule-IV (AUDADIS-IV): Reliability of alcohol consumption, tobacco use, family history of depression and psychiatric diagnostic modules in a general population sample. Drug and Alcohol Dependence, 71(1), 7-16.

Adult

English, Available in other languages

≥18 years

Interviewer must be trained and found competent to conduct personal interviews with individuals from the general population. The interviewer should be trained to prompt respondents further if a "don’t know" response is provided.

While the Alcohol Use Disorder and Associated Disabilities Interview Schedule-IV (AUDADIS-IV) instrument was developed for administration by computer, the PhenX Working Group acknowledges that these questions can be administered in a noncomputerized format. Hasin et al. (1997) and Grant et al. (1995) used the AUDADIS in paper-and-pencil format, while Grant et al. (2003) obtained data with the computerized format.

Standard	Name	ID	Source
Common Data Elements (CDE)	Person Substance of Abuse Consumption Indicator	2821039	CDE Browser
Logical Observation Identifiers Names and Codes (LOINC)	Substance - lifetime use proto	62505-3	LOINC

Grant, B. F., Dawson, D. A., Stinson, F. S., Chou, P. S., Kay, W., & Pickering, R. (2003). The Alcohol Use Disorder and Associated Disabilities Interview Schedule-IV (AUDADIS-IV): Reliability of alcohol consumption, tobacco use, family history of depression and psychiatric diagnostic modules in a general population sample. Drug and Alcohol Dependence, 71(1), 7-16.

Grant, B. F., Harford, T. C., Dawson, D. A., Chou, P. S., & Pickering, R. P. (1995). The Alcohol Use Disorder and Associated Disabilities Interview Schedule (AUDADIS): Reliability of alcohol and drug modules in a general population sample. Drug and Alcohol Dependence, 39(1), 37-44.

Hasin, D., Carpenter, K. M., McCloud, S., Smith, M., & Grant, B. F. (1997). The alcohol use disorder and associated disabilities interview schedule (AUDADIS): Reliability of alcohol and drug modules in a clinical sample. Drug and Alcohol Dependence, 44(2-3), 133-141.

Interviewer-administered questionnaire

None

Requirement Category	Required
Average time of greater than 15 minutes in an unaffected individual	No
Major equipment	No
Specialized requirements for biospecimen collection	No
Specialized training	No

The Expert Review Panel has not reviewed this measure yet.