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Abstract: Patients with opioid use disorder (OUD) frequently present to the emergency department (ED) after overdose, or seeking treatment for medical conditions, their addiction, withdrawal symptoms, or complications from injection drug use, such as soft tissue infections. ED-initiated buprenorphine has been shown to be effective in increasing patient engagement in treatment compared with brief intervention with a facilitated referral or referral alone. However, adoption into practice has lagged behind need. To address this implementation change, we are evaluating the impact of implementation facilitation (IF) on the adoption of ED-initiated buprenorphine for OUD into practice. This article describes a study that is being conducted through the NIDA Clinical Trials Network (CTN-0099). A hybrid type III effectiveness-implementation study design is being used to evaluate the effectiveness of a standard educational dissemination strategy versus IF on implementation (primary) and effectiveness (secondary) outcomes in four urban, academic EDs. Sites start with a standard 60-minute “Grand Rounds” educational intervention describing the prevalence of ED patients with OUD, the evidence for opioid agonist treatment and for innovative interventions with ED-initiated buprenorphine, followed by a 1-year baseline evaluation period. Using a modified stepped wedge design, sites are randomly assigned to the IF intervention, which is guided by the Promoting Action on Research Implementation in Health Services (PARiHS) framework to assess evidence, context, and facilitation-related factors impacting the adoption of ED-initiated buprenorphine. During the 6 months of IF through the 1-year IF evaluation period, external facilitators will work with local stakeholders to tailor and refine a bundle of activities to meet the site’s needs. The primary analyses will compare the baseline evaluation period to the IF evaluation period (n=120 patients with untreated OUD enrolled during each period) on (1) rates of provision of ED-initiated buprenorphine by ED providers with referral for ongoing medication (implementation outcome) and (2) rates of patient engagement in addiction treatment on the 30th day after the ED visit (effectiveness outcome). Finally, researchers will perform a cost-effectiveness analysis (CEA) to determine if the effectiveness benefits are worth the additional costs. Conclusions: The ED is rapidly being identified as a “24/7/365” site to combat the opioid crisis by offering access to medications for opioid use disorder treatment. Sustainable, evidence-based practice implementation is a complex and challenging process. This study has the potential to identify an implementation strategy that can be translated to other EDs, thereby increasing the adoption of ED-initiated buprenorphine into practice, narrowing the gap between OUD identification and treatment. Related protocols: CTN-0099

Abstract:

This study, supported in part by a CTN Invest Fellowship awarded to the first author, aimed to assess the prevalence of non-opioid drug use among opioid-addicted buprenorphine injecting individuals in Georgia (former Soviet republic), during and after a 12-week course of buprenorphine-naloxone (Suboxone) or methadone. This randomized, controlled trial used daily observed Suboxone or methadone and weekly counseling, urine tests, and Timeline Followback (TLFB) in weeks 0-12, and 20, as well as the Addiction Severity Index (ASI) at weeks 0, 4, 8, 12, and 20. Of the 80 patients (40/group, 4 women), 68 (85%) completed the 12 weeks of study treatment and 66 (82.5%) completed the 20 week follow-up.

At baseline, injecting more than one drug in the last 30 days was reported by 68.4% of patients in the methadone and 72.5% in the Suboxone groups. Drug use was markedly reduced in both treatment conditions, but there were significant differences in the prevalence of specific drugs with more opioid (1.5 vs. 0.2%; p = 0.03), less amphetamine (0.2 vs. 2.8%; p < 0.001) and less marijuana (1.7 vs. 10.2%; p < 0.001) positive urine tests in the methadone vs. Suboxone groups. At the 20 week follow-up, TLFB results on the 34 that continued methadone or the 3 on Suboxone showed less opioid (5.6 vs. 27.6%; p < 0.001), illicit buprenorphine (2.7 vs. 13.8%; p = 0.005), benzodiazepine (13.5 vs. 34.5%; p < 0.001), and marijuana (2.8 vs. 20.7%; p < 0.001) use than the 29 who did not continue opioid substitution therapy.

Conclusions: Daily observed methadone or buprenorphine-naloxone therapy with weekly counseling was markedly effective in reducing not only opioid use, but use of other psychoactive substances in Georgia, though there was more non-opioid use in patients treated with Suboxone, and more opioid use in patients treated with methadone. As in other settings, stopping opioid substitution therapy was associated with relapse to non-prescribed and other drug use.

Abstract:

Since first being identified in 1989, HCV has quickly gained attention as a public health concern due to its intense proliferation and negative consequences associated with chronic infection. In comparison with other blood-borne illnesses, HCV is now far more common than HIV/AIDS; and unlike HBV, HCV lacks available vaccines. Because injection drug use is by far the most significant risk factor for contracting HCV, and continued substance use among infected persons raises the risk for developing complications, as well as spreading the infection, this study sought to better understand the risk factors associated with HCV among patients enrolled into medication-assisted therapy for opioid dependence. Patients (N=1039) were randomized as part of a larger, multisite clinical trial sponsored by the National Drug Abuse Treatment Clinical Trials Network (CTN-0027) assessing liver function in opioid-dependent participants randomized to medication condition (buprenorphine/naloxone or methadone). HCV status was first assessed with an antibody screen; if positive, then current infection was determined with an antigen screen testing for detectable virus. Patients were classified as HCV negative, HCV positive but have cleared the virus, or as having chronic HCV. Logistic regression analysis was used to examine demographic and behavioral correlates of the three groups.

Thirty-four percent of patients were classified with chronic infection and 14% had evidence of prior infection with apparent clearing of the virus. Chronic infection was associated with recent injection drug use and cocaine use. Chronic HCV infection was also associated with being older and Hispanic.

Conclusions: Age, ethnicity, and current drug use increase the likelihood of being chronically infected with HCV. Strategies targeting high risk subgroups can aid in preventing further disease escalation. Further research would benefit from better understanding the role of ethnicity in transmission and/or spontaneous remission. Early intervention and continuous monitoring of IDUs should be the primary focus for addressing this epidemic.

Related protocols: CTN-0027

Abstract:

The prevalence of hepatitis-C-virus (HCV) infections is high among opioid-dependent individuals. Prior research on the simultaneous treatment of both conditions has primarily assessed success as it pertains to HCV. However, it has been noted that favorable substance use therapy outcomes may improve the likelihood of HCV-treatment initiation and success. Therefore, current guidelines for the treatment of HCV among illicit drug users suggest that treatment for addiction be given the highest priority. This study aimed to determine whether opioid-dependent participants in a clinical trial of buprenorphine-treatment tapering regimens, who tested positive for the HCV antibody, experienced significantly different levels of opioid abstinence than those not infected. Data came from the National Drug Abuse Treatment Clinical Trials Network study CTN-0003, which compared two taper schedules for buprenorphine-naloxone (one rapid and one gradual, n=516). Participants with the HCV antibody were significantly less likely to submit opioid-negative urine analyses during and/or immediately following active treatment, indicating a higher rate of opioid use among this group.

Conclusions: Individualized opioid-dependence treatment strategies may be required for opioid-dependent individuals who test positive for the HCV antibody in order to ensure resources for both opioid-dependence and HCV therapies are used efficiently.

Abstract:

This is the Results Article for CTN-0045-Ot.

Increasing rates of HIV testing within substance use disorder (SUD) treatment clients is an important public health strategy for reducing HIV transmission rates. This study from the National Drug Abuse Treatment Clinical Trials Network (“Rates of HIV Testing and Barriers to Testing in African Americans Receiving Substance Abuse Treatment,” CTN-0045-Ot) examined uptake of HIV testing among 1,224 clients in five SUD treatment units that offered on-site testing in Florida, New York, and California. Nearly one-third (30%) of the participants, who had not previously tested positive, reported not having been tested for HIV within the past 12 months. Women, African Americans, and injection drug users had a higher likelihood of having been tested within the past 12 months. The SUD treatment program was the most frequently identified location of participants’ last HIV test. Of those who were tested in the previous 12 months, 5% tested positive, suggesting that testing of SUD treatment clients has the potential to identify new cases of HIV and, thereby, potentially reduce further transmission.

Conclusions: Despite the availability of free, on-site testing, a substantial proportion of clients were not tested, suggesting that strategies to increase uptake of testing should include addressing barriers not limited to location and cost. Though the majority of HIV tests will have negative results, the benefits of finding even a small number of cases far outweigh the costs.

Related protocols: CTN-0045-Ot

Abstract:

Research over the past 20 years has shown that methadone maintenance (MET) reduces opioid use and is an effective HIV risk reduction intervention. Like methadone, treatment with buprenorphine-naloxone (BUP) also appears to reduce HIV risk. To date, only one study has compared HIV risk in patients receiving MET versus BUP. This article reports on a similar comparison of a much larger samples in a secondary analysis of data from the National Drug Abuse Treatment Clinical Trials Network (CTN) protocol “Starting Treatment with Agonist Replacement Therapies (START).” START was a randomized, open-label phase 4 study in participants entering opioid agonist treatment programs throughout the country that aimed to compare the effect of BUP and MET on liver function. The Risk Behavior Survey (RBS) was administered to participants, measuring past 30-day HIV risk, at baseline and weeks 12 and 24.

Among the 529 patients randomized to MET, 391 (74%) were completers; among the 740 randomized to BUP, 340 (46%) were completers; 700 completed the RBS. There were significant reductions in injecting risk with no differences between groups in mean number of times reporting injecting heroin, speedball, other opiates, and number of injections. There were also no differences between groups in terms of percent who shared needles, did not clean shared needles with bleach, shared cookers, or engaged in front/back loading of syringes. The percent having multiple sex partners decreased equally in both groups. For males on BUP, the sex risk composite increased; for males on MET, the sex risk decreased, resulting in significant group differences over time. For females there was a significant reduction in sex risk with no group differences.

Conclusions: Among MET and BUP patients who remained in treatment, HIV injecting risk was equally and markedly reduced, however MET retained more patients. Sex risk was equally and significantly reduced among females in both treatment conditions, but increased for males on BUP and decreased for males on MET. Overall, these findings further support the important of expanding availability of evidence-based medical treatments for opioid addiction.

Related protocols: CTN-0027

Abstract:

This secondary analysis of data from National Drug Abuse Treatment Clinical Trials Network protocol CTN-0027 (Starting Treatment with Agonist Replacement Therapies (START)”) explored differences in baseline clinical characteristics and opioid replacement therapy treatment outcomes by type (heroin, opioid analgesic (OA), or combined (heroin and OA)), and route (injector or non-injector) of opioid use. A total of 1,269 participants (32.2% female) were randomized to receive one of two study medications (methadone or buprenorphine/naloxone (BUP)). Of these, 731 participants completed the 24-week active medication phase. Treatment outcomes were opioid use during the final 30 days of treatment (among treatment completers) and treatment attrition. Non-opioid substance dependence diagnoses and injecting differentiated heroin and combined users from OA users. Non-opioid substance dependence diagnoses and greater heroin use differentiated injectors from non-injectors. Further, injectors were more likely to be using at end of treatment compared with non-injectors. OA users were more likely to complete treatment compared with heroin users and combined users. Non-injectors were more likely than injectors to complete treatment. There were no interactions between type of opioid used or injection status and treatment assignment (methadone or BUP) on either opioid use or treatment attrition.

Conclusions: Findings indicate that substance use severity differentiates heroin users from opioid analgesic users and injectors from non-injectors. Irrespective of medication, heroin use and injecting are associated with treatment attrition and opioid misuse during treatment. These results have particular clinical interest, as there is no evidence of superiority of BUP over methadone for treating opioid analgesic users versus heroin users. Programs offering maintenance therapies may benefit from targeting retention efforts on heroin and injection users. Potential interventions should include assuring that medication doses are optimized, using contingency management, or directing interventions to specific problem areas of individual patients.

Related protocols: CTN-0027

Abstract:

HIV infection disproportionately impacts minorities, yet research on racial/ethnic differences in the prevalence and correlates of HIV risk behaviors is limited. This study examined racial/ethnic differences in the rates of HIV risk behaviors and whether the relationship between HIV risk factors and HIV risk behaviors varies by race/ethnicity in clients participating in National Drug Abuse Treatment Clinical Trial Network (CTN) trials. The sample was 41% non-Hispanic White, 32% non-Hispanic Black, and 27% Hispanic (N = 2,063). HIV risk behaviors and measures of substance and psychosocial HIV risk factors in the past month were obtained. Non-Hispanic Blacks engaged in less HIV sexual risk behaviors overall than non-Hispanic Whites. While non-Hispanic Whites were the most likely to report any injection drug use, Hispanics engaged in the most HIV drug risk behaviors. Specific risk factors were differentially predictive of HIV risk behavior by race/ethnicity. Alcohol use severity was related to engaging in higher sex risk behaviors for non-Hispanic Blacks and Whites. Greater psychiatric severity was related to engaging in higher sex risk behaviors for non-Hispanic Whites. Drug use severity was associated with engaging in higher risk drug behaviors for non-Hispanic Whites and Hispanics, with the magnitude of the relationship stronger for Hispanics.

Conclusions: The findings from the present study suggest that there is a context in which HIV high risk behaviors occur within racial/ethnic groups as well as differences in the presence of risk factors associated with engaging in those behaviors. These findings are consistent with calls to culturally adapt evidence-based interventions and the need to maintain core elements of the intervention when adapting the intervention for increased relevance to the new targets. Further research testing HIV risk prevention interventions within racial/ethnic groups is needed to identify target behaviors or risk factors that are salient to inform HIV interventions.

Related protocols: CTN-0001, CTN-0002, CTN-0004, CTN-0005, CTN-0006, CTN-0007, CTN-0021

Abstract:

Racial and ethnic minorities and injection drug users (IDUs) are at increased risk of HIV infection. However, the associations between these patient characteristics and the availability of onsite HIV testing in substance use disorder treatment programs are unknown. This paper explored patient caseload characteristics associated with the availability of HIV testing in a sample of substance use disorder (SUD) treatment programs affiliated with the National Drug Abuse Treatment Clinical Trials Network (CTN). The authors found that almost half of programs (48%) provided onsite HIV testing for SUD patients, which is nearly double the rates reported by privately funded treatment programs and programs responding to the most recent National Survey of Substance Abuse Treatment Services. About 52% of CTN-affiliated programs offering onsite HIV testing services used a rapid test. Results also showed positive associations between the percentages of African American, Hispanic, and injection drug-using patients and the odds of offering non-rapid onsite HIV testing versus no onsite testing at all.

Conclusions: This finding is promising and suggests that rapid HIV testing may be a feasible innovation that can be successfully adopted by SUD treatment programs. The study also suggests that many programs are responding well to the needs of at-risk populations. Treatment programs and their patients may benefit from greater adoption of rapid testing which is less costly and better ensures that patients receive their results.

Abstract:

Injection drug use (IDU) is a primary vector for blood-borne infections. Awareness of Hepatitis C virus (HCV) infection status may affect risky injection behaviors. This study determines the prevalence of risky injection practices and examines associations between awareness of positive HCV status and risky injection behaviors. In this study, part of protocol CTN-0012, a national HIV screening trial, individuals seeking treatment for substance abuse at 12 community treatment programs were surveyed. Participants reported socio-demographic characteristics, substance use, risk behaviors, and HCV status. Researchers used multivariable logistic regression to test associations between participant characteristics and syringe/needle sharing. The 1281 participants included 244 (19%) individuals who reported injecting drugs in the past 6 months and 37.7% of IDUs reported being HCV positive. During the six months preceding baseline assessment, the majority of IDUs reported obtaining sterile syringes from pharmacies (51.6%) or syringe exchange programs (25%), but fewer than half of IDUs always used a sterile syringe (46.9%). More than one-third (38.5%) shared syringe/needles with another injector in the past 6 months. Awareness of positive HCV vs. negative/unknown status was associated with increased recent syringe/needle sharing (aOR 2.37, 95% CI 1.15, 4.88) in multivariable analysis.

Conclusions: Risky injection behaviors remain prevalent and awareness of HCV infection was associated with increased risky injection behaviors. This study highlights the need for broadly implemented HCV prevention interventions for all IDUs seeking addiction treatment, and suggests such interventions might particularly decrease transmission behaviors of those aware of their HCV infection and prevent HCV infections in those HCV-negative/unaware. As HCV screening and treatment options advance, community based treatment programs have a greater opportunity to play a central role in reducing HCV transmissions and engaging HCV-infected IDUs in treatment.

Related protocols: CTN-0012

Abstract:

This article reports on an ancillary investigation of data from protocols CTN-0001 and CTN-0002 (Buprenorphine/Naloxone versus Clonidine for Inpatient/Outpatient Opiate Detoxification). The sample included 343 opioid-dependent adults enrolled in the protocols. Researchers examined associations between depressive symptoms, co-occurring substance use (i.e., the use of substances other than opioids), and HIV-related sexual and injection risk behaviors. Data were collected using the Addiction Severity Index and the HIV Risk Behavior Scale, and analyzed using linear regression. Depressive symptoms were associated with an increased level of injection risk behaviors but were not associated with risky sexual behaviors. The co-occurring use of amphetamines also increased the likelihood of risky sexual behaviors.

Conclusions: Treatment of depression can make a contribution to decreasing injection risk among opioid-dependent injection drug users, especially if combined with other risk reduction interventions. This study also revealed that noninjecting amphetamine use was independently associated with sexual risk behaviors among opioid-dependent individuals.

Supported by the Duke Clinical Research Institute (CTN DSC 1).

Related protocols: CTN-0001, CTN-0002

Abstract:

In response to the rising rate of treatment admissions related to illicit use of amphetamines (e.g., methamphetamine), this ancillary investigation examined the prevalence of amphetamine use among treatment-seeking, opioid-dependent adults, explored whether amphetamine users were as likely as non-amphetamine users to enroll in opioid-dependence treatment trials, and determined whether amphetamine users manifested greater levels of medical and psychiatric comorbidity than nonusers. The sample included 1257 opioid-dependent adults screened for participation in three multisite studies of the National Drug Abuse Treatment Clinical Trials Network (protocols CTN-0001, -0002, and -0003), which studied the effectiveness of buprenorphine for opioid detoxification under varying treatment conditions. Five mutually exclusive groups were examined, i.e., nonusers, current amphetamine injectors, current amphetamine non-injectors, former amphetamine injectors, and former amphetamine non-injectors Of the sample, 22.3% had a history of regular amphetamine use; of those users, 30.3% reported injection as their primary route. Amphetamine users were as likely as nonusers to enroll in treatment trials. Bivariate analyses indicated elevated rates of psychiatric problems (depression, anxiety, etc.) and medical illnesses (dermatological, hepatic, etc.) among amphetamine users. After adjusting for demographic variables and lifetime use of other substances: current amphetamine users and former injectors showed an increased likelihood of having medical illnesses and hospitalizations; current injectors had elevated odds of suicidal thoughts or attempts; current non-injectors had exhibited elevated odds of anxiety, cognitive impairment, and violent behaviors; and former non-injectors had increased odds of depression.

Conclusions: Treatment-seeking, amphetamine-using, opioid-dependent adults manifest greater levels of medical and psychiatric morbidity than treatment-seeking, opioid-dependent adults who have not used amphetamines, indicating a greater need for intensive clinical management.

Supported by the Duke Clinical Research Institute (CTN DSC 1).

Abstract:

Protocol CTN-0017, “HIV and HCV Prevention in Drug Treatment Settings” was a study of 632 drug injectors that tested three interventions to reduce drug and sex risk behaviors. Participants were randomized to (a) a two-session, HIV/HCV counseling and education (C&E) model added to treatment as usual (TAU), (b) a one-session therapeutic alliance (TA) intervention conducted by outpatient counselors to facilitate treatment entry plus TAU, or (c) TAU. Significant reductions in drug and sex risk behaviors occurred for all three conditions over a 6-month follow-up period. C&E participants reported significantly greater rates of attending an HIV testing appointment, but this was not associated with better risk reduction outcomes. Reporting treatment participation within 2 months after detoxification and self-efficacy to practice safer injection behavior predicted reductions in injection risk behaviors.

Findings indicate that participation in detoxification was followed by significant decreases in drug injection and risk behaviors for up to six months; interventions added to standard treatment offered no improvement in risk behavior outcomes. The study supports the importance of access to detoxification for drug injectors followed by transition to continued treatment.

Related protocols: CTN-0017

Abstract:

As a member of the Oregon/Hawaii Node, the community treatment program (CTP) CODA, Inc. frequently participates in NIDA’s CTN clinical trials, including the recently completed rapid HIV testing trial (CTN-0032). Incorporating research lessons learned from the CTN experience into their treatment practice, CODA, a medication-assisted treatment (MAT) program for opioid dependence, expanded its electronic medical record data to include high risk behaviors, infectious diseases and greater attention to non-prescription use of opioid analgesics. The goal is to more appropriately tailor the substance abuse treatment to the identified needs of the local patient population. The self-reported prevalence of Hepatitis C (HCV) in new MAT patients is 35% and 49% in heroin dependent individuals. Despite being the group at highest risk for HCV, needle using heroin patients, when asked to assess their HCV risk, 58% reported being at low to no risk. The heroin dependent patients were also the individuals most likely to report engaging in high-risk behaviors such as “sex for drugs” or needle sharing. These findings illustrate the need for onsite rapid HCV testing and use of intensive HCV prevention curriculum. Non-prescription use of opioid analgesics rose to 33% of all new CODA patients seeking treatment and constitutes the drug of choice for 46% of women beginning MAT. All MAT withdrawals occurring before 90 days of treatment were in the heroin dependent patients. Clinical implications for ways to increase patient retention based on drug of choice and reduction in behaviors associated with compromised outcomes will be discussed.

Related protocols: CTN-0032

Abstract:

Injection drug use (IDU) remains an important means of hepatitis C transmission. The aim of this study, which analyzed data from patients enrolling in protocol CTN-0032, was to estimate the effect of awareness of hepatitis C diagnosis on risky injection behaviors among drug treatment clients. Of 1281 participants, 49% reported injecting drugs in the past 6 months (current) or previously but not in the last 6 months (former). Among 264 current IDUs, 35% reported they were positive for HCV and 39% had shared needles/works with another injector in the past 6 months. Those who shared needles were also more likely to have sex with a condom in the past 6 months (77% vs. 59%). In multivariable analysis, awareness of positive hepatitis C status vs. negative or unknown status was associated with increased odds of sharing needles or works after adjusted for age, gender, race, education, source of needles, and substance use. Awareness of hepatitis C positivity was associated with increased risky injection behaviors among injection drug users presenting for substance abuse treatment.

Hepatitis C screening in treatment programs may identify clients in need of targeted harm reduction interventions.

Related protocols: CTN-0032