An Exploratory Assessment of Substances Used as Adjuncts or Alternatives to Prescription Opioids

OMB Control No. 0910-0847

Expiration Date: 12/31/2022

Attachment A

Individual Interview Screening Questionnaire

“An Exploratory Assessment of Substances Used as Adjuncts or Alternatives to Prescription Opioids”

Our treatment center has been selected as one of ten centers nationwide to participate in a research study aimed at understanding the factors that influence use of prescription opioids and other substances, and we’d like to see whether you qualify to participate. The study is being sponsored by the US Food and Drug Administration. The individual interviews will be conducted here by independent researchers who work for a company called Mark Herring Associates. Each interview will last 60 minutes, and all participants will receive a $50 gift card as a token of appreciation.

Your participation is totally voluntary. If you complete an interview, your session will be audio-recorded and transcribed, but your name or other identifying information will NOT be included in the transcript or the research report.

All of your responses will be kept secure to the extent permitted by law. The staff here at the treatment center will not have access to the information you provide during the interview.

To figure out whether you qualify to participate in this research study, I’d like to ask you a few questions. May I continue?

1. How old were you on your last birthday? _______________ Years [RECORD ACTUAL AGE]

[DO NOT READ]

1. Under 18 years of age [THANK AND TERMINATE]

2. Over 18 years of age [CONTINUE]

3. Refused to Say [THANK AND TERMINATE]

2. Have you ever worked for any of the following types of organizations?

[READ LIST and obtain a response for each item]

1. A drug company [IF YES, THANK AND TERMINATE]

2. A market research or marketing company [IF YES, THANK AND TERMINATE]

3. A hospital, a doctor’s office, a home health agency or some other type of health care organization? [IF YES, THANK AND TERMINATE]

4. U.S. Food and Drug Administration (FDA) [IF YES, THANK AND TERMINATE]

5. U.S. Department of Health and Human Services (HHS) [IF YES, THANK AND TERMINATE]

6. None of the above [CONTINUE]

3. Are you a doctor, nurse, nurse practitioner, physician assistant or pharmacist?

[DO NOT READ]

1. Yes [THANK AND TERMINATE]

2. No [CONTINUE]

Now I’m going to ask about some of the substances you used before you entered this current treatment program.

4. During the 12 months before you entered treatment, did you use prescription opioids?

[DO NOT READ]

1. Yes [CONTINUE]

2. No [THANK AND TERMINATE]

3. Don’t Know/Not Sure [THANK AND TERMINATE]

4. Refused to Say [THANK AND TERMINATE]

5. During the 12 months before you entered treatment, what is the name of the prescription opioid you used most often?

___________________________________ [Write down brand name or generic name]

6. What other prescription opioids did you use during the 12 months before beginning treatment? [GIVE “PRESCRIPTION OPIOIDS” WORKSHEET TO RESPONDENT]

6. During the 12 months before you entered treatment, did you use kratom with a prescription opioid or as a substitute for a prescription opioid?

[DO NOT READ]

1. Yes

2. No

3. Don’t Know/Not Sure

4. Refused to Say

6. During the 12 months before you entered treatment, did you use cannabidiol or CBD with a prescription opioid or as a substitute for a prescription opioid?

[DO NOT READ]

1. Yes

2. No

3. Don’t Know/Not Sure

4. Refused to Say

6. During the 12 months before you entered treatment, did you use gabapentin (Neurontin, Gralise, Horizant) or pregabalin (Lyrica, Lyrica CR) with a prescription opioid or as a substitute for a prescription opioid?

[DO NOT READ]

1. Yes

2. No

3. Don’t Know/Not Sure

4. Refused to Say

6. During the 12 months before you entered treatment, did you use a benzodiazepine with a prescription opioid or as a substitute for a prescription opioid?

[DO NOT READ]

1. Yes

2. No

3. Don’t Know/Not Sure

4. Refused to Say

6. What is the name of the benzodiazepine you used most often during the 12 months before beginning treatment?

_____________________________________[Write down brand name or generic name]

6. What other benzodiazepine did you use during the 12 months before beginning treatment? [GIVE “BENZODIAZEPINES” WORKSHEET TO RESPONDENT]

6. [NOTE TO INTERVIEWER: After questions 4-12, please circle the letter beside the category the respondent qualifies for; if the person has used more than one of these substances, circle the letter to show which quota you are filling; please circle only ONE letter]

1. Opioids and kratom

2. Opioids and CBD

3. Opioids and gabapentin or pregabalin

4. Opioids and benzodiazepines

If respondent does not qualify or if quota already filled, please read the following:

I’m sorry, but you are not eligible for this study. There are many possible reasons why people are not eligible. These reasons were decided earlier by the researchers. However, thank you for your interest in this study and for taking the time to answer our questions today.

[If respondent qualifies, please go on.]

I just need to ask you a couple of additional questions about your background, then we’ll be through.

6. What is the highest level of education you have completed? Is it:

[READ LIST]

1. Less than high school graduate

2. High school graduate or completed GED

3. Some college or technical school

4. Bachelor’s degree

5. Some postgraduate studies

6. Graduate degree

7. Don’t Know/Not Sure [DO NOT READ]

8. Refused to Say [DO NOT READ]

6. [DOCUMENT SEX]

1. Male

2. Female

6. Are you Hispanic, Latino or of Spanish origin?

[DO NOT READ]

1. Yes

2. No

6. Which of the following best describes your race? Mark one or more of the following:

[READ LIST]

1. White

2. Black or African-American

3. American Indian or Alaska Native

4. Native Hawaiian or Other Pacific Islander

5. Asian

6. What state do you live in? _____________

6. Which of the following best describes the area you live in?

[READ LIST]

A. Urban (in a city)

B. Suburban

C. Rural

6. What was your employment status before you entered treatment? Were you:

[READ LIST]

1. Unemployed

2. Employed part time

3. Employed full time

4. Other: ______________

6. What is your marital status? Are you:

[READ LIST]

1. Married

2. Divorced

3. Widowed

4. Single

22. Is your drug treatment being partially or fully paid for by health insurance?

[DO NOT READ]

A. Yes

B. No

C. Don’t Know/Not Sure [DO NOT READ]

D. Refused to Say [DO NOT READ]

23. Would you be comfortable being interviewed about the prescription opioids and other substances you have taken for this research study?

[DO NOT READ]

A. Yes [CONTINUE]

B. No [THANK AND TERMINATE]

C. Don’t Know/Not Sure [THANK AND TERMINATE]

D. Refused to Say [THANK AND TERMINATE]

24. Would you be willing to participate in an interview on [INSERT DATE] at [INSERT TIME]?

[DO NOT READ]

A. Yes [CONTINUE]

B. No [THANK AND TERMINATE]

C. Don’t Know/Not Sure [THANK AND TERMINATE]

D. Refused to Say [THANK AND TERMINATE]

First Name of Study Participant: __________________________________________

Date and Time of Interview: _____________________________________________

Screener closing:

Thank you! We’ll remind you about your interview and show you where to go to meet with the interviewer. You’ll receive a $50 gift card after your interview is complete.