Long-term outcomes from the National Drug Abuse Treatment Clinical Trials Network Prescription Opioid Addiction Treatment Study.

BACKGROUND: Despite the growing prevalence of prescription opioid dependence, longitudinal studies have not examined long-term treatment response. The current study examined outcomes over 42 months in the Prescription Opioid Addiction Treatment Study (POATS). METHODS: POATS was a multi-site clinical trial lasting up to 9 months, examining different durations of buprenorphine-naloxone plus standard medical management for prescription opioid dependence, with participants randomized to receive or not receive additional opioid drug counseling. A subset of participants (N=375 of 653) enrolled in a follow-up study. Telephone interviews were administered approximately 18, 30, and 42 months after main-trial enrollment. Comparison of baseline characteristics by follow-up participation suggested few differences. RESULTS: At Month 42, much improvement was seen: 31.7% were abstinent from opioids and not on agonist therapy; 29.4% were receiving opioid agonist therapy, but met no symptom criteria for current opioid dependence; 7.5% were using illicit opioids while on agonist therapy; and the remaining 31.4% were using opioids without agonist therapy. Participants reporting a lifetime history of heroin use at baseline were more likely to meet DSM-IV criteria for opioid dependence at Month 42 (OR=4.56, 95% CI=1.29-16.04, p<.05). Engagement in agonist therapy was associated with a greater likelihood of illicit-opioid abstinence. Eight percent (n=27/338) used heroin for the first time during follow-up; 10.1% reported first-time injection heroin use. CONCLUSIONS: Long-term outcomes for those dependent on prescription opioids demonstrated clear improvement from baseline. However, a subset exhibited a worsening course, by initiating heroin use and/or injection opioid use.

The multi-site prescription opioid addiction treatment study: 18-month outcomes.

Despite the high prevalence of prescription opioid dependence in the U.S., little is known about the course of this disorder and long-term response to treatment. We therefore examined 18-month post-randomization outcomes of participants in the Prescription Opioid Addiction Treatment Study, a multi-site, randomized controlled trial examining varying durations of buprenorphine-naloxone treatment and different intensities of counseling for prescription opioid dependence. Thus the current follow-up study provides a unique contribution to the field by reporting longer-term outcomes of a well-characterized population of treatment-seeking prescription opioid dependent patients. Participants from the treatment trial (N=252/653) completed an 18-month follow-up telephone assessment. Multivariable analyses examined associations between participant characteristics and key indicators of month-18 status: opioid abstinence, DSM-IV opioid dependence, and opioid agonist treatment. Overall, participants showed improvement from baseline to month 18: 49.6% were abstinent in the previous 30 days, with only 16.3% opioid-dependent. Some participants, however, had initiated past-year heroin use (n=9) or opioid injection (n=17). Most participants (65.9%) engaged in substance use disorder treatment during the past year, most commonly opioid agonist therapy (48.8%). Of particular interest in this population, multivariable analysis showed that greater pain severity at baseline was associated with opioid dependence at 18 months. In conclusion, although opioid use outcomes during the treatment trial were poor immediately following a buprenorphine-naloxone taper compared to those during 12 weeks of buprenorphine-naloxone stabilization, opioid use outcomes at 18-month follow-up showed substantial improvement over baseline and were comparable to the rate of successful outcomes during buprenorphine-naloxone stabilization in the treatment trial.

Identifying patients with problematic drug use in the emergency department: results of a multisite study.

STUDY OBJECTIVE: Drug-related emergency department (ED) visits have steadily increased, with substance users relying heavily on the ED for medical care. The present study aims to identify clinical correlates of problematic drug use that would facilitate identification of ED patients in need of substance use treatment. METHODS: Using previously validated tests, 15,224 adult ED patients across 6 academic institutions were prescreened for drug use as part of a large randomized prospective trial. Data for 3,240 participants who reported drug use in the past 30 days were included. Self-reported variables related to demographics, substance use, and ED visit were examined to determine their correlative value for problematic drug use. RESULTS: Of the 3,240 patients, 2,084 (64.3%) met criteria for problematic drug use (Drug Abuse Screening Test score ≥ 3). Age greater than or equal to 30 years, tobacco smoking, daily or binge alcohol drinking, daily drug use, primary noncannabis drug use, resource-intense ED triage level, and perceived drug-relatedness of ED visit were highly correlated with problematic drug use. Among primary cannabis users, correlates of problematic drug use were age younger than 30 years, tobacco smoking, binge drinking, daily drug use, and perceived relatedness of the ED visit to drug use. CONCLUSION: Clinical correlates of drug use problems may assist the identification of ED patients who would benefit from comprehensive screening, intervention, and referral to treatment. A clinical decision rule is proposed. The correlation between problematic drug use and resource-intense ED triage levels suggests that ED-based efforts to reduce the unmet need for substance use treatment may help decrease overall health care costs.

Who benefits from additional drug counseling among prescription opioid-dependent patients receiving buprenorphine-naloxone and standard medical management?

BACKGROUND: In the multi-site Prescription Opioid Addiction Treatment Study (POATS), conducted within the National Drug Abuse Clinical Trials Network, participants randomly assigned to receive individual drug counseling in addition to buprenorphine-naloxone and medical management did not have superior opioid use outcomes. However, research with other substance-dependent populations shows that subgroups of participants may benefit from a treatment although the entire population does not. METHOD: We conducted a secondary analysis of POATS data to determine whether a subgroup of participants benefited from drug counseling in addition to buprenorphine-naloxone and medical management, either due to greater problem severity or more exposure to counseling as a result of greater treatment adherence. Problem severity was measured by a history of heroin use, higher Addiction Severity Index drug composite score, and chronic pain. Adequate treatment adherence was defined a priori as attending at least 60% of all offered sessions. RESULTS: Patients who had ever used heroin and received drug counseling were more likely to be successful (i.e., abstinent or nearly abstinent from opioids) than heroin users who received medical management alone, but only if they were adherent to treatment and thus received adequate exposure to counseling (OR=3.7, 95% CI=1.1-11.8, p=0.03). The association between severity and outcome did not vary by treatment condition for chronic pain or ASI drug severity score. CONCLUSIONS: These findings emphasize the importance of treatment adherence, and suggest that patients with prescription opioid dependence are a heterogeneous group, with different optimal treatment strategies for different subgroups.

Psychometric properties of a Spanish-language version of the Short Inventory of Problems.

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. 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 (α = .96), and construct validity was supported through correlations with composite scores from the Addiction Severity Index (ASI) (e.g., r = .57, p < .01 for ASI drug composite), 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 (ß = -.22, p < .01) and fewer days retained in treatment (ß = -.14, p < .05). However, the latter association was moderated by participants' legal status. Nevertheless, 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.

Patient characteristics associated with buprenorphine/naloxone treatment outcome for prescription opioid dependence: Results from a multisite study.

BACKGROUND: Prescription opioid dependence is a growing problem, but little research exists on its treatment, including patient characteristics that predict treatment outcome. METHODS: A secondary analysis of data from a large multisite, randomized clinical trial, the National Drug Abuse Treatment Clinical Trials Network Prescription Opioid Addiction Treatment Study (POATS) was undertaken to examine baseline patient characteristics (N=360) associated with success during 12-week buprenorphine/naloxone treatment for prescription opioid dependence. Baseline predictor variables included self-reported demographic and opioid use history information, diagnoses assessed via the Composite International Diagnostic Interview, and historical opioid use and related information from the Pain And Opiate Analgesic Use History. RESULTS: In bivariate analyses, pre-treatment characteristics associated with successful opioid use outcome included older age, past-year or lifetime diagnosis of major depressive disorder, initially obtaining opioids with a medical prescription to relieve pain, having only used opioids by swallowing or sublingual administration, never having used heroin, using an opioid other than extended-release oxycodone most frequently, and no prior opioid dependence treatment. In multivariate analysis, age, lifetime major depressive disorder, having only used opioids by swallowing or sublingual administration, and receiving no prior opioid dependence treatment remained as significant predictors of successful outcome. CONCLUSIONS: This is the first study to examine characteristics associated with treatment outcome in patients dependent exclusively on prescription opioids. Characteristics associated with successful outcome after 12 weeks of buprenorphine/naloxone treatment include some that have previously been found to predict heroin-dependent patients' response to methadone treatment and some specific to prescription opioid-dependent patients receiving buprenorphine/naloxone.

The Short Inventory of Problems - revised (SIP-R): psychometric properties within a large, diverse sample of substance use disorder treatment seekers.

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 national, multisite, randomized clinical trials. 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 (α = .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. 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.