Opioid/Benzodiazepine Polydrug Abuse

Primary outcomes

1. Psychopathology

   Time frame: Administered once during the baseline clinical assessment.

   Semi-Structured Clinical Interview for DSM (Face-to-face interview) Evaluates lifetime and current psychiatric and substance use disorders.

2. Beck Depression Inventory-II

   Time frame: Administered during the baseline clinical assessment, and at the 3-month follow-up visit.

   Questionnaire measure of current depression symptoms

3. Snaith-Hamilton Pleasure Scale

   Time frame: Administered during the baseline clinical assessment, and at the 3-month follow-up visit.

   Questionnaire 14-item scale that measures anhedonia, the inability to experience pleasure. The items cover the domains of: social interaction, food and drink, sensory experience, and interest/pastimes. A score of 2 or less constitutes a "normal" score, while an "abnormal" score is defined as 3 or more. Each item has four possible responses: strongly disagree, disagree, agree, or strongly agree. Either of the "disagree" responses score one point, and either of the "agree" responses score 0 points.

4. Perceived Stress Scale

   Time frame: Administered during the baseline clinical assessment, and at the 3-month follow-up visit.

   Questionnaire that measures the degree to which situations in one's life are appraised as stressful. Items were designed to assess how unpredictable, uncontrollable, and overloaded respondents find their lives to be. The scale also includes a number of direct queries about current levels of experienced stress.

5. State-Trait Anxiety Inventory

   Time frame: Administered during the baseline clinical assessment, and at the 3-month follow-up visit.

   Questionnaire that differentiates state anxiety from chronic trait anxiety symptoms.

6. Difficulties with Emotion Regulation Scale

   Time frame: Administered during the baseline clinical assessment, and at the 3-month follow-up visit.

   36-item questionnaire measure of six facets of emotion regulation. Items are rated on a scale of 1 ("almost never [0-10%]") to 5 ("almost always [91-100%]"). Higher scores indicate more difficulty in emotion regulation. measures 6 empirically valid constructs related to emotion dysregulation: Non-acceptance of emotional responses, Difficulties in engaging in goal-directed behavior, Impulse control difficulties, Lack of emotional awareness, Limited access to emotion regulation strategies, and Lack of emotional clarity.

7. Alcohol and Drug Use Self-Efficacy Scale

   Time frame: Administered during the baseline clinical assessment, and at the 3-month follow-up visit.

   Questionnaire assesses self-efficacy and responses to high-risk situations that can trigger substance use.Items are grouped into negative affect, social positive withdrawal/urges, and physical/other concerns; subjects indicate how "tempted" and "confident" they would be in each situation.

8. Distress Tolerance Scale

   Time frame: Administered once during the clinical assessment.

   Questionnaire measure of emotional distress tolerance

9. Positive and Negative Affect Schedule-Short Form: Positive Affect

   Time frame: Administered once during the baseline clinical assessment.

   Questionnaire: 10-item measure of Positive Affect

10. Positive and Negative Affect Schedule-Short Form: Negative Affect

    Time frame: Administered once during the baseline clinical assessment.

    Questionnaire: 10-item measure of Negative Affect

11. Paced Auditory Serial Addition Task

    Time frame: Administered once during the baseline clinical assessment.

    mental arithmetic task with 3 trial blocks of increasing difficulty. Subjects can escape the task during block 3; latency (sec) to task termination is a primary outcome.

12. Brief Pain Inventory-Short Form

    Time frame: Administered during the baseline clinical assessment, and at the 3-month follow-up visit.

    Questionnaire measures pain severity (0=no pain; 10=pain as bad as you can imagine) and its functional impact (0=no interference; 10= interferes completely).

13. Current Opioid Misuse Measure

    Time frame: Administered during the baseline clinical assessment, and at the 3-month follow-up visit.

    Questionnaire measures risk of opioid misuse

14. Insomnia Severity Index

    Time frame: Administered during the baseline clinical assessment, and at the 3-month follow-up visit.

    Questionnaire asks about problem severity of sleep-onset, sleep-maintenance, early morning awakening, sleep satisfaction, interference with daily function, perceived impairment, and level of distress from insomnia. It has good internal consistency and concurrent validity (with polysomnography, sleep diaries, and clinician or significant-other reports), making it a valid and reliable measure of perceived sleep disturbance.

15. Epworth Sleepiness Scale

    Time frame: Administered once during the baseline clinical assessment.

    Questionnaire measures 'sleep propensity', i.e. recent likelihood of dozing or falling asleep (rather than just feeling tired) in several situations.

16. Psychomotor Vigilance Task

    Time frame: Administered once during the baseline clinical assessment.

    computerized, adaptive task (reaction time to a visual stimulus presented at random inter-trial intervals [ITI]) that will be used to assess attentional lapses; this objective, validated measure of sleepiness.

17. Go/No-Go Task

    Time frame: Administered once during the baseline clinical assessment.

    Immediate and Delayed Memory Task assesses response inhibition. Participants are told to press a button to respond to stimulus X or Y presented in an alternating pattern (Go) and to withhold responding when the pattern is broken (No-Go). We will use percentage of correctly inhibited responses for each presentation.

18. California Verbal Learning Test-Revised

    Time frame: Administered once during the baseline clinical assessment.

    Immediate and delayed memory will be assessed.

19. Emotional Stroop Task

    Time frame: Administered once during the baseline clinical assessment.

    reaction time assessment of attentional bias for both emotion-related words

20. Wisconsin Card Sort Test

    Time frame: Administered once during the baseline clinical assessment.

    number of items correct, measuring ability to shift or maintain cognitive set

21. Digit Symbol Substitution Test

    Time frame: Administered once during the baseline clinical assessment.

    Psychomotor processing speed and associative ability will be assessed.

22. Drug History Questionnaire

    Time frame: Administered once during the baseline clinical assessment.

    assesses lifetime substance use (e.g. age of initial and regular use, sequence of use of opioids and BZDs, adverse consequences of use, quit attempts.

23. Timeline Followback interview

    Time frame: Administered during the baseline clinical assessment, and at the 3-month follow-up visit

    Assesses all substance use over the past 30 days; this will generate detailed data on patterns of opioid, BZD and alcohol use (e.g. simultaneous vs. concurrent, including customized queries to determine whether using one drug primes use of another, under what affective conditions (positive, neutral, negative) substances are used together, and number of days since last use (which could influence affective, neurocognitive or behavioral measures).

24. Opioid /Benzodiazepine Purchasing Task

    Time frame: Administered once during the baseline clinical assessment.

    Hypothetical purchasing tasks (economic simulations) will assess drug demand. will be tailored to each subject's preferred opioid (e.g. heroin, oxycodone, hydrocodone) or benzodiazepine based on screening self-report.

25. Urinalysis

    Time frame: At baseline clinical assessment, and at the 3-month follow-up visit

    One urine sample will be collected and tested for opioids, methadone, cocaine, amphetamines, barbiturates, and cannabinoids using a 6-panel CLIA waived drug test. The urine sample will be collected into multi-test cups with temperature strips (CLIA Waived; temperature must be 92-96º F). Samples will be tested for opioids, methadone, cocaine, amphetamines, barbiturates (negative cutoff <300 ng/ml), and cannabinoids (negative cutoff < 50ng/ml).