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Abstract: Objectives: Timeline follow-back (TLFB) is a self-report measure commonly used as a method of assessing historical drug use in both clinical and research settings. Our study considered rates of agreement between TLFB and an objective biological assay of opioid use. Methods: We calculated the rates of agreement between negative report of opioid use for the most recent 8 days on TLFB and urine toxicology (UTOX) results in a large multisite opioid use disorder treatment trial (CTN-0051, X:BOT). Results: In total, 3986 assessments were provided by trial participants with both UTOX and TLFB during weeks 1 to 12, 2716 during weeks 13 to 24, and 325 at week 28. Rates of disagreement between negative TLFB and positive opioid UTOX were 2.33% of all assessments (21.68% of those with positive UTOX) over weeks 1 to 12, 2.06% of all assessment (25.00% of those with positive UTOX) over weeks 13 to 24, and 9.85% of all assessments (26.02% of those with positive UTOX) at week 28. Conclusions: Negative TLFB seems to be generally associated with negative results on urine toxicology. Related protocols: CTN-0051

Abstract:

Timeline Follow-back (TLFB) interviews using self-report are often used to assess substance use. Oral fluid testing (OFT) offers an objective measure of substance use. There are limited data on the agreement between TLFB and OFT.

In this secondary analysis of data from CTN-0059 (TAPS Tool), a multisite study in five primary care sites, self-reported TLFB and OFT data collected under confidential conditions were compared to assess concordance (N=1799). OFT samples were analyzed for marijuana, heroin, cocaine, and non-medical use of prescription opioids. Demographic differences in discordance relative to TLFB and OFT concordant results for marijuana, the only substance with an adequate sample size in this analysis, were examined using multinomial logistic regression.

Overall concordance rates between TLFB and OFT were 94.9 % or higher for each substance, driven by large subgroups with no use. Among participants with discordant use, marijuana was the only substance with lower detection on OFT than self-report (27.6 % OFT-positive only vs 32.2 % TLFB-positive only), whereas cocaine (65.6 % vs 8.6 %), prescription opioids (90.4 % vs 6.0 %), and heroin (40.7 % vs 26.0 %) all had higher detection via OFT than TLFB. Participants who reported marijuana use but had a negative OFT were more likely to be younger, Hispanic, and White compared to those with TLFB and OFT concordant positive results.

Conclusions: TLFB and OFT show disparate detection of different substances. Researchers should consider the implications of using either self-report or oral fluid testing in isolation, depending on the substance and collection setting. Triangulating multiple sources of information may improve detection of drug use.

Related protocols: CTN-0059

Abstract:

There is a need to monitor patients receiving prescription opioids to detect possible signs of abuse. To address this need, the authors developed and calibrated an item bank for severity of abuse of prescription pain medication as part of the Patient-Reported Outcomes Measurement Information System (PROMIS). Comprehensive literature searches yielded an initial bank of 5,310 items relevant to substance use and abuse, including abuse of prescription pain medication, from over 80 unique instruments. After qualitative item analysis (i.e., focus groups, cognitive interviewing, expert review, and item revision), 25 items for abuse of prescribed pain medication were included in field testing. Items were written in a first-person, past-tense format, with a three-month time frame and five response options reflecting frequency or severity. The calibration sample included 448 respondents, 367 from the general population (ascertained through an internet panel) and 81 from community treatment programs participating in the National Drug Abuse Treatment Clinical Trials Network.

A final bank of 22 items was calibrated using the two-parameter graded response model from item response theory. A seven-item static short form was also developed. The test information curve showed that the PROMIS item bank for abuse of prescription pain medication provided substantial information in a broad range of severity.

Conclusions: The initial psychometric characteristics of the item bank support its use as a computerized adaptive test or short form, with either version providing a brief, precise, and efficient measure relevant to both clinical and community samples. The new item bank adds to the existing body of PROMIS measures; further studies of the validity of the item bank are now appropriate to develop a better understanding of its measurement properties.

Abstract:

This secondary analysis of data from NIDA Clinical Trials Network protocol CTN-0047 (Screening Motivational Assessment and Referral to Treatment in Emergency Departments (SMART-ED)) aimed to investigate the utility of hair analysis in drug use disorder trials with infrequent visits, and its concordance with Timeline Follow Back (TLFB). This study compared the self-reported drug use on the TLFB instrument with the biological measure of drug use from hair analysis for four major drug classes (cannabis, cocaine, prescribed opioids, and street opioids). Both hair analysis and TLFB were conducted at 3, 6, and 12 month follow-up visit and each covered a 90-day recall period prior to the visit.

The concordance between the hair sample results and the TLFB was high for cannabis and street opioids, but was low to moderate for cocaine and prescribed opioids. Under-reporting of drug use given the positive hair sample was always significantly lower for the drug the study participant noted as their primary drug of choice compared with other drugs the participant reported taking, irrespective of whether the drug of choice was cannabis, cocaine, street opioids, and prescribed opioids. Over-reporting of drug use given the negative hair sample was always significantly higher for the drug of choice, expect for cocaine.

Conclusions: This study extends the literature on hair analysis supporting its use as a secondary outcome measure in clinical trials, particularly when assessing long-term abstinence, given its extended window of detection compared to typical follow-up sessions, for which urine drug testing may be more appropriate. Reliability varied considerably by drug category and by site, indicating that the target drug and participant characteristics should be considered when weighing the pros and cons of employing hair testing as an objective cost measure.

Related protocols: CTN-0047

Abstract:

This secondary analysis of data from the National Drug Abuse Treatment Clinical Trials Network’s “Screening Motivational Assessment and Referral to Treatment in Emergency Departments (SMART-ED)” study (CTN-0047) aimed to examine predictors of agreement between hair analyses and self-report of drug use. Self-reported drug use during follow-up over a 90-day recall period on the Timeline Follow Back Instrument was compared to drug use from hair analysis for Cannabis, Cocaine, Prescribed Opioids [PO] and Street Opioids[SO]. Measures of agreement/disagreement, including under-reporting (self report negative when hair indicates drug use) and over-reporting (self-report positive when hair does not indicate drug use) were calculated. The following variables were examined as predictors of disagreement: source of hair (head vs. body), drug of choice, site, AUDIT-C score, DAST-10 score, visit, treatment arm, sex, race, ethnicity and age. Of the 1,285 randomized participants, 1120 (87%), 875 (68%), 893 (69%) and 832 (65%) provided hair samples at baseline, 3-, 6-, 12-month visits, respectively.

The agreement between the hair sample results and TLFB was high for cannabis (cohen’s = 0.49-0.54) and SO ( = 0.73-0.81), but lower for cocaine ( = 0.31-0.35) and PO ( = 0.18-0.30). Drug of choice, irrespective of being cannabis, cocaine, SO or PO, had statistically significantly lower under-reporting of drug use compared with other self-reported drug use (all p-values < .01). Of note, females (p=.0085; F vs M; OR = 1.33) and older age (p=.0076; 45-<55 vs 18-<25; OR = 2.02) were associated with under-reporting of cannabis use. Few predictors of over-reporting were identified.

Conclusions: Hair collection can be an important biological measure to assess drug use, and can be used to assist in corroborating self-report. From these analyses, there are a number of factors that impact agreement between drug use as measured by hair and drug use through self-report.

Related protocols: CTN-0047

Abstract:

Although research has generally supported the validity of substance use self-reports, some patients deny urine-verified substance use. This study examined the prevalence and patterns of denying urinalysis-confirmed opioid use in a sample of prescription opioid dependent patients. It also identified characteristics associated with denial in this population of increasing public health concern. Opioid use self-reports were compared with weekly urinalysis results in the National Drug Abuse Treatment Clinical Trials Network’s 12-week multi-site treatment study for prescription opioid dependence (CTN-0030 Prescription Opioid Addiction Treatment Study (POATS)). Among those who used opioids during the trial (n=246/360), 44.3% (n=109) denied urinalysis-confirmed opioid use, although usually only once (78%). Overall, 22.9% of opioid-positive urine tests (149/650) were denied on self-report. Multivariable analysis found that initially using opioids to relieve pain was associated with denying opioid use.

Conclusions: The present study shows that, although the clear majority of self-reports were consistent with urine results, many participants denied urine-confirmed use, albeit infrequently, despite knowing they would be tested. This result, combined with the finding that 7% of the positive self-reports were provided in a week with a negative urine test, shows the importance of obtaining both self-report data and urine tests; neither one alone is adequate.

Related protocols: CTN-0030

Abstract:

Hispanic Americans are substantially underrepresented in clinical and research samples for substance use treatment, with language cited as one of the major barriers to their participation, indicating a need for more validated assessments in Spanish. This study evaluated the psychometric properties of a Spanish version of the Short Inventory of Problems (SIP), used in a multisite, randomized trial conducted for Spanish-speaking substance users, National Drug Abuse Treatment Clinical Trials Network protocol CTN-0021. The sample included 405 Spanish-speaking treatment seekers, mostly male (88%) and legally mandated to treatment (71%). The Spanish version of the revised SIP (SIP-RS), as well as other commonly used assessment measures translated into Spanish, were administered at baseline and at the end of treatment. Internal consistency was excellent and construct validity was supported through correlations with composite scores from the Addiction Severity Index (ASI) and through differential SIP-RS scores according to diagnostic criteria. The SIP-RS also demonstrated an association with substance use and treatment retention, with higher baseline scores associated with significantly less abstinence during treatment and fewer days retained in treatment. However, the latter association was moderate by participants’ legal status.

Conclusions: This Spanish-translated version of the SIP (SIP-RS) appears to be a reliable and valid assessment of adverse consequences associated with alcohol and drug use, with psychometric properties comparable with the English version. This assessment may prove to be a useful outcome measure for evaluating the efficacy of treatments for substance use disorders, and it may have the potential to identify individuals at risk for early treatment drop-out. Given the growing population of Hispanics in the United States with limited English proficiency, greater effort should be placed toward validating substance abuse assessment instruments for Spanish-speakers, with a particular focus on diverse Hispanic populations.

Related protocols: CTN-0021

Abstract:

Objective measures of drug use are very important in treatment outcome studies of persons with substance use disorders, but obtaining and interpreting them can be challenging and not always practical. Thus, it is important to determine if, and when, drug use self-reports are valid. To this end we explored the relationships between urine drug screen results and self-reported substance use among adolescents and young adults with opioid dependence participating in a clinical trial of buprenorphine-naloxone. In this study (National Drug Abuse Treatment protocol CTN-0010), 152 individuals seeking treatment for opioid dependence were randomized to a 2-week detoxification with buprenorphine-naloxone (DETOX) or 12 weeks buprenorphine-naloxone (BUP), each with weekly individual and group drug counseling. Urine drug screens and self-reported frequency of drug use were obtained weekly, and patients were paid $5 for completing weekly assessments. At weeks 4, 8, and 12, more extensive assessments were done, and participants were reimbursed $75. Self-report data were dichotomized (positive vs. negative), and for each major drug class the kappa statistic and the sensitivity, specificity, positive predictive value were computed, as well as the negative predictive value of self-report using urine drug screens as the “gold standard.” Generalized linear mixed models were used to explore the effect of treatment group assignment, compensation amounts, and participant characteristics on self-report.

Conclusions: In general, findings support the use of self-report of drug use as a valid outcome measure in treatment studies of adolescents and young adults with opioid use disorders. However, those in the BUP group were more likely to under-report cocaine and opioid use. Therefore, if used alone, self-report would have magnified the treatment effect of the BUP condition. Future studies could further define the predictors of greater or lower probability of over- and under-reporting, so that interpretations of treatment studies using self-report as primary outcome measures can be more accurate.

Related protocols: CTN-0010

Abstract:

This article reports on the development and calibration of item banks for alcohol use, negative and positive consequences of alcohol use, and negative and positive expectancies regarding drinking as part of the Patient-Reported Outcomes Measurement Information System (PROMIS). Comprehensive literature searches yielded an initial bank of more than 5000 items from over 200 instruments. After qualitative item analysis (including focus groups and cognitive interviewing), 141 items were included in field testing. Items for alcohol use and consequences were written in a first-person, past-tense format with a 30-day time frame and 5 response options reflecting frequency. Items for expectancies were written in a third-person, present-tense format with no time frame specified and 5 response options reflecting intensity. The calibration sample included 1407 respondents, 1000 from the general population (ascertained through an internet panel) and 407 from community treatment programs participating in the National Institute on Drug Abuse (NIDA) National Drug Abuse Treatment Clinical Trials Network (CTN). Final banks of 37, 31, 20, 11, and 9 items (108 total items) were calibrated for alcohol use, negative consequences, positive consequences, negative expectancies, and positive expectancies, respectively, using item response theory (IRT). Seven-item static short forms were also developed from each item bank.

Conclusions: Test information curves showed that the PROMIS item banks provided substantial information in a broad range of severity, making them suitable for treatment, observational, and epidemiological research. For more information about the NIH Roadmap initiative that resulted in the development of the PROMIS, visit http://www.nihpromis.org.

Abstract:

This study sought to examine the psychometric properties of a revised version of the SIP (SIP-R) as a measure of adverse consequences for alcohol and drug users in both English and Spanish-speaking populations. The English version was evaluated within a large population of alcohol and drug abuse treatment seekers (N=886) pooled from two national, multisite randomized trials (protocols CTN-0004 and -0005). It was also translated into Spanish and evaluated in a large population of Spanish-speaking substance abuse treatment seekers (N=405) participating in a separate multisite randomized trial (CTN-0021). All trials utilized a common assessment battery that included the ASI, the URICA, and a substance use calendar. Reliability and validity analyses included internal consistency, confirmatory factor analysis, and correlations. Differences in reported consequences were explored using ANOVA. For the English version, results supported the internal consistency and theoretical five-factor structure. Convergent validity was evident through strong correlations with the URICA and the drug composite score from the ASI, whereas weak correlations with other composite scores provided evidence of discriminant validity. Results for the Spanish version were highly similar, with strong internal consistency, factor structure, and a similar pattern of correlations with the ASI and URICA. In both the English and Spanish-speaking samples, baseline SIP-R total scores were higher for those not legally mandated to treatment and were associated with days retained in treatment.

Conclusions: This is the first study to evaluate the SIP-R within such a large, diverse sample of treatment seekers, including evaluation of a Spanish version. Both the English and Spanish versions of the SIP-R demonstrated strong psychometric properties and should be considered a valuable measure of adverse consequences associated with drug and alcohol use.

Related protocols: CTN-0004, CTN-0005, CTN-0021

Abstract:

Assessment of the adverse consequences of substance use serves an important function in both clinical and research settings, yet there is no universally agreed upon measure of consequences relevant to multiple types of substance use disorders. One of the most commonly used measures, the Short Inventory of Problems (SIP), has been adapted and evaluated in several specific populations, but evidence is needed of its reliability and validity across broader samples of persons with substance use disorders. This study evaluated the psychometric properties of a revised version of the SIP (SIP-R) in a large combined sample of alcohol and drug use disorder treatment seekers, with participants pooled from two studies from the National Drug Abuse Treatment Clinical Trials Network (CTN-0004, about motivational enhancement therapy, and CTN-0005, about motivational interviewing).

A total of 886 participants across 10 outpatient treatment facilities completed a common assessment battery that included the SIP-R, Addiction Severity Index (ASI), University of Rhode Island Change Assessment (URICA), HIV Risk Behavior Scale (HRBS), and a substance use calendar. Results supported the SIP-R’s internal reliability (alpha = .95). Confirmatory factor analysis demonstrated that the hypothesized 5-factor model with one higher-order factor produced the best fit. Convergent validity was evident through the SIP-R’s correlation with several composite scores from the ASI and the URICA, and analyses supported its conceptual distinction from quantity indices of drug/alcohol use. The SIP-R also demonstrated an ability to predict treatment retention, with higher scores associated with poorer retention.

Conclusions: These results provide support for the SIP-R’s psychometric properties as a measure of consequences across a broad sample of treatment-seeking drug and alcohol users.

Related protocols: CTN-0004, CTN-0005

Abstract:

Using self-report to gather information about drug use can be reasonably reliable and valid in certain situations, especially where there are no contingencies for reported use, and where certain measures are taken during the information gathering process. However, there are some contexts which make the self-report data less useful, due to inaccuracies. The purpose of this study was to explore overall concordance between urine drug screen results and self-report in an adolescent and young adult population by doing secondary analyses of a randomized controlled trial of a 12-week suboxone treatment versus a 14-day suboxone detoxification in opioid addicted youth ages 15-21 (protocol CTN-0010).

Results found strong relationships between self-report and urine drug screens for most substances. With respect to opioid use, participants in the 12-week group had concordance rates similar to participants in the detox group, but self-report was less sensitive and more specific in the 12-week group. In general these findings support the validity of self-report under similar conditions.

Related protocols: CTN-0010