1 / 19

Overview of Substance Use Outcomes in Other SUD trials

This overview explores the assessments, definitions, and preferred outcome measures in trials for alcohol, tobacco, and stimulant substance use disorders. It discusses the accuracy of self-reporting, common outcomes such as abstinence percentages and drinking days, the role of biomarkers, recommendations for grace periods, reduction measures, and preferred outcomes. The assessment and measurement of outcomes for alcohol, tobacco, and stimulant use disorders are examined in detail.

tessief
Download Presentation

Overview of Substance Use Outcomes in Other SUD trials

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Overview of Substance Use Outcomes in Other SUD trials Brian D. Kiluk, Ph.D. Yale School of Medicine ACTTION Meeting March 23, 2018

  2. OUTLINE • Published reviews of outcomes in trials for tobacco, alcohol, stimulants • Assessments for measurement of outcomes • Definitions of treatment success • Consideration of grace period • Recommended/approved outcomes

  3. ALCOHOL: Assessment

  4. ALCOHOL: Assessment * Self-reports are generally accurate and can be used with confidence when: • Alcohol free when interviewed • Given written assurances of confidentiality • Interviewed in setting that encourages honest reporting • Clearly worded objective questions • Provided memory aids

  5. ALCOHOL: Common Outcomes • Percent days abstinent (PDA) or Percent days drinking (PDD) • Days of alcohol abstinence (or use) / Total days • Percentage of Heavy Drinking Days (PHDD) • Heavy drinking day = any day consuming 4+/5+ drinks for women/men • Drinks per Day (DPD) • Number of total drinks / number of days during specified period • Drinks per Drinking Day (DDD) • Number of total drinks / number of drinking days during specified period * Biomarkers commonly used to validate self-report, not as outcome * Transdermal alcohol monitors – days of no drinking

  6. ALCOHOL: Preferred Outcomes

  7. ALCOHOL: Grace Period Falk et al 2010 • PSNHDD • Effect sizes based on various grace periods • COMBINE and Topiramate

  8. ALCOHOL: Reduction Measures • World Health Organization (WHO) risk levels • Increased mortality risk at each level of consumption • European Medicines Agency • Reduction by 2 categories • Nalmefene approval • Witkiewitz et al 2017 (COMBINE) • 1-level reduction • Reduced DrInC; better mental health • Hasin et al 2017 (NESARC) – Table 1 • 1-level reduction • Lowered odds of alcohol dependence

  9. TOBACCO: Assessment

  10. TOBACCO: Outcomes • Hughes et al., (2003) • Workgroup formed by Society of Nicotine and Tobacco Research • Gathered information via literature searches to evaluate pros and cons of abstinence measures • Included logic, clinical wisdom, and consensus among experts • Abstinence measures based on percentage of individuals abstinent • Any smoking treated as failure • Those lost to follow-up treated as SMOKERS

  11. TOBACCO: Common Outcomes • Continuous abstinence • Proportion of people not smoking at all since quit date • Prolonged abstinence • Proportion abstinent for some specified interval of extended duration • Point prevalence abstinence • Proportion not smoking at a point in time (immediately preceding follow-up) • Repeated point prevalence • Point prevalence abstinence at 2 or more follow-ups between which smoking is allowed

  12. Hughes, Carpenter, & Naud (2010) • 28 RCTs of validated pharmacotherapies • Reported both PA & PP • PP & PA highly correlated • r = .88 • Produce similar estimates of effect size • PP slightly higher when absolute difference used

  13. TOBACCO: Recommendations from workgroup

  14. STIMULANTS: Assessment

  15. STIMULANTS: Common Outcomes • Percentage of days abstinent (PDA) • Self-reported days of abstinence / total days in specified period • Longest duration of abstinence • Maximum number of self-reported days • Percentage of positive (or negative) urine toxicology results • Urine result only; highly variable based on denominator • Percentage of subjects achieving abstinence of ‘x’ duration • Based on dichotomous indicator of achieving abstinence or not • Donovan et al, Addiction (2012) • No single clinical metric appropriate for all trials • Ideally would combine self-report and biological indicators • Most appropriate outcome will vary by study methods and goals

  16. STIMULANTS: Comparison of Outcomes Carroll et al (2014) • Pooled data across 5 RCTs evaluating treatment for cocaine (N=434) • Compared common continuous and dichotomous outcomes • Reduction indicators based on days of cocaine use • Evaluated correlations with cocaine use during follow-up • Determined sensitivity to effects of pharmacologic and behavioral treatments * Rates of discordance b/w self-report and urine results ranged 8-16%

  17. STIMULANTS: Preferred Outcomes MOST Meeting - Kiluk et al (2016) • No single preferred outcome • Reduction-based measures defined by quantity should be abandoned • Any reduction should be based on days of use • Urine drug screens are essential component • Used to corroborate self-report rather than primary outcome • Pursue low-risk cocaine use by evaluating patterns (‘intermittent use’) • E.g., 1-4 days per month

  18. SUMMARY OF OUTCOMES

More Related