Substance use Attitudes, Beliefs, Experience, and Knowledge Among Nursing and Nursing Assistant Students.

Stigma is a public health concern. Stigmatizing attitudes toward persons with substance use disorders (SUDs) can adversely impact clinical care and outcomes. Beliefs about SUD, prior experience and familiarity to persons with SUD, and educational curricula drive attitudes among health-care workers. In 2019, nursing and nursing assistant students were recruited through an online survey platform. Participants completed an SUD knowledge test and a survey assessing education, beliefs, personal experience, and confidence in recognizing the signs and symptoms of SUD. One hundred and ten health-care students (nursing students, n = 67 and nursing assistant students, n = 43) completed the survey. Among nursing assistant students, endorsing a disease model of addiction (F(2, 40) = 5.83, p < .001, R2 = .23), and personal familiarity with SUD (F(2, 40) = 4.46, p < .001, R2 = .18), were significantly positively predictive of positive regard toward working with persons with SUD. For nursing students, endorsing a disease model of addiction, educational curricula involving persons with SUD, and personal familiarity were significantly positively predictive of positive regard toward working with persons with SUDs (F(2, 61) = 11.52, p < .001, R2 = .36). Interventions to mitigate drug-related stigma among health-care students should center students with personal familiarity, promote the disease concept of addiction, and incorporate contact-based training.

iVY: protocol for a randomised clinical trial to test the effect of a technology-based intervention to improve virological suppression among young adults with HIV in the USA.

INTRODUCTION: Young adults with HIV (YWH) experience worse clinical outcomes than adults and have high rates of substance use (SU) and mental illness that impact their engagement in care and adherence to antiretroviral therapy (ART). The intervention for Virologic Suppression in Youth (iVY) aims to address treatment engagement/adherence, mental health (MH) and SU in a tailored manner using a differentiated care approach that is youth friendly. Findings will provide information about the impact of iVY on HIV virological suppression, MH and SU among YWH who are disproportionately impacted by HIV and at elevated risk for poor health outcomes. METHODS AND ANALYSIS: The iVY study will test the effect of a technology-based intervention with differing levels of resource requirements (ie, financial and personnel time) in a randomised clinical trial with an adaptive treatment strategy among 200 YWH (18-29 years old). The primary outcome is HIV virological suppression measured via dried blood spot. This piloted and protocolised intervention combines: (1) brief weekly sessions with a counsellor via a video-chat platform (video-counselling) to discuss MH, SU, HIV care engagement/adherence and other barriers to care; and (2) a mobile health app to address barriers such as ART forgetfulness, and social isolation. iVY has the potential to address important, distinct and changing barriers to HIV care engagement (eg, MH, SU) to increase virological suppression among YWH at elevated risk for poor health outcomes. ETHICS AND DISSEMINATION: This study and its protocols have been approved by the University of California, San Francisco Institutional Review Board. Study staff will work with a Youth Advisory Panel to disseminate results to YWH, participants and the academic community. TRIAL REGISTRATION NUMBER: NCT05877729.

Pre-implementation Assessment of Tobacco Cessation Interventions in Substance Use Disorder Residential Programs in California.

BACKGROUND: Across the United States, substance use disorder (SUD) treatment programs vary in terms of tobacco-related policies and cessation services offered. Implementation of tobacco-related policies within this setting can face several barriers. Little is known about how program leadership anticipate such barriers at the pre-implementation phase. This study used the Consolidated Framework for Implementation Research (CFIR) during the pre-implementation stage to identify factors that may influence the implementation stage of tobacco-related cessation policies and services in residential SUD programs. METHODS: We conducted semi-structured qualitative interviews with sixteen residential treatment program directors in California. The analysis was guided by a deductive approach using CFIR domains and constructs to develop codes and identify themes. ATLAS.ti software was used to facilitate thematic analysis of interview transcripts. FINDINGS: Themes that arose as anticipated facilitators for implementation included the relative advantage of the intervention vs. current practice, external policies/incentives to support tobacco-related policy, program directors' strong commitment and high self-efficacy to incorporate cessation into SUD treatment, and recognizing the importance of planning and engaging opinion leaders. Potential barriers included the SUD recovery culture, low stakeholder engagement, organizational culture, lack of workforce expertise, and lack of reimbursement for smoking cessation services. CONCLUSION: To support successful implementation of tobacco-related organizational change interventions, staff and clients of residential SUD programs require extensive education about the effectiveness of evidence-based medications and behavioral therapies for treating tobacco dependence. Publicly funded SUD treatment programs should receive support to address tobacco dependence among their clients through expanded reimbursement for tobacco cessation services.

Methadone maintenance patients lack analgesic response to a cumulative intravenous dose of 32 mg of hydromorphone.

OBJECTIVES: Acute pain management in patients with opioid use disorder who are maintained on methadone presents unique challenges due to high levels of opioid tolerance in this population. This randomized controlled study assessed the analgesic and abuse liability effects of escalating doses of acute intravenous (IV) hydromorphone versus placebo utilizing a validated experimental pain paradigm, quantitative sensory testing (QST). METHODS: Individuals (N = 8) without chronic pain were maintained on 80-100 mg/day of oral methadone. Participants received four IV, escalating/incremental doses of hydromorphone over 270 min (32 mg total) or four placebo doses within a session test day. Test sessions were scheduled at least one week apart. QST and abuse liability measures were administered at baseline and after each injection. RESULTS: No significant differences between the hydromorphone and placebo control conditions on analgesic indices for any QST outcomes were detected. Similarly, no differences on safety or abuse liability indices were detected despite the high doses of hydromorphone utilized. Few adverse events were detected, and those reported were mild in severity. CONCLUSIONS: The findings demonstrate that methadone-maintained individuals are highly insensitive to the analgesic effects of high-dose IV hydromorphone and may require very high doses of opioids, more efficacious opioids, or combined non-opioid analgesic strategies to achieve adequate analgesia.

COVID-19 vaccine trust among clients in a sample of California residential substance use treatment programs.

BACKGROUND: Individuals with a substance use disorder (SUD) are at a significantly higher risk for coronavirus disease-19 (COVID-19) and have higher rates of COVID-19 related hospitalization and death than those without SUD. This study assessed COVID-19 vaccine trust, transmission awareness, risk and protective behaviors, and effects of COVID-19 on mental health and smoking among a sample of clients in California residential SUD treatment programs and identified factors associated with vaccine trust. METHODS: A multi-site sample of SUD treatment clients (n = 265) completed a cross-sectional survey. Multivariable logistic regression was used to identify factors associated with COVID-19 vaccine trust. RESULTS: Participants were predominantly male (82.3 %) and racially/ethnically diverse (33.3 % Non-Hispanic White). Most participants were aware of COVID-19 modes of transmission, however, only 39.5 % trusted a COVID-19 vaccine would be safe and effective. Factors independently associated with trust in a COVID-19 vaccine included age (AOR = 1.03, 95 % CI = 1.02, 1.05, p = 0.0001) and wearing a mask all the time (AOR = 2.48, 95 % CI = 1.86, 3.31, p = 0.0001). African Americans were less likely than White participants to trust that a COVID-19 vaccine is safe and effective (AOR = 0.41, 95 % CI = 0.23, 0.70, p = 0.001). CONCLUSION: SUD treatment clients were aware of COVID-19 modes of transmission; however, fewer than half trusted that a COVID-19 vaccine would be safe and effective. Health communication about COVID-19 for people with SUD should use a multipronged approach to address COVID-19 vaccine mistrust and transmission risk behaviors.

Video-Counseling Intervention to Address HIV Care Engagement, Mental Health, and Substance Use Challenges: A Pilot Randomized Clinical Trial for Youth and Young Adults Living with HIV.

Background: Substance use and mental health are two barriers to engagement in care and antiretroviral therapy (ART) adherence among youth and young adults living with HIV (YLWH). The consequences of suboptimal adherence in YLWH are increased risk of HIV transmission and a future generation of immunodeficient adults with drug-resistant virus. Methods: The Youth to Telehealth and Texting for Engagement in Care (Y2TEC) study was a pilot randomized crossover trial that examined the feasibility and acceptability of a novel video-counseling series and accompanying text messages aimed at mental health, substance use, and HIV care engagement for YLWH. The intervention consisted of twelve 20-30-min weekly video-counseling sessions focused on identifying and addressing barriers to HIV care, mental health, and substance use challenges. Participants completed quantitative surveys at baseline, 4 months, and 8 months. Feasibility and acceptability were evaluated using prespecified benchmarks. Results: Fifty YLWH aged 18-29 years living in the San Francisco Bay Area were enrolled. Eighty-six percent and 75% of participants were retained at 4 and 8 months, respectively. A total of 455 (76%) video-counseling sessions were completed. In 82% of sessions, participants responded that they strongly agreed/agreed with this statement: "I felt heard, understood, and respected by the counselor." In 81% of sessions, participants responded that they strongly agreed/agreed with this statement: "Overall, today's session was right for me." At baseline, among participants reporting mental health challenges, only 10% noted having ever received mental health services, and among those who reported substance use challenges, ∼19% reported ever receiving substance use services. After 4 months of the Y2TEC intervention, participants reported slightly higher ART adherence and HIV knowledge, decreased depression and anxiety, and reduced stigma related to mental health and substance use. Conclusions: The Y2TEC intervention using video-counseling and text messaging was feasible and acceptable for YLWH. ClinicalTrials.gov ID: NCT03681145.

Addressing HIV care, mental health and substance use among youth and young adults in the Bay Area: description of an intervention to improve information, motivation and behavioural skills.

OBJECTIVE: Youth represent a population disparately impacted by the HIV epidemic. With most new HIV diagnoses occurring among adolescents and young adults, novel approaches to address this disparity are necessary. The objective of the current study was to describe the Youth to Telehealth and Text to Improve Engagement in Care (Y2TEC) intervention, which aims to fill this gap. The Y2TEC intervention (trial registration NCT03681145) offers an innovative approach to improve HIV treatment engagement among youth living with HIV by focusing on treatment barriers related to mental health and substance use. This allows for a holistic approach to providing culturally informed intervention strategies for this population. PARTICIPANTS AND SETTING: The Y2TEC intervention was developed for youth with HIV in the large metropolitan area of the San Francisco Bay Area. The Y2TEC intervention was developed based on formative interdisciplinary research and is grounded in the information-motivation-behavioural skills model. RESULTS: The intervention includes 12 sessions each lasting 20-30 minutes, which are delivered through videoconferencing and accompanying bidirectional text messaging. The intervention sessions are individualised, with session dosage in each major content area determined by participant's level of acuity. CONCLUSIONS: The Y2TEC intervention is well positioned to help decrease HIV-related disparities in youth living with HIV through its innovative use of video-counselling technologies and an integrated focus on HIV, mental health and substance use.

Use of technology for delivery of mental health and substance use services to youth living with HIV: a mixed-methods perspective.

Disparities in HIV treatment outcomes among youth living with HIV (YLWH) present a challenge for ending the HIV epidemic. Antiretroviral therapy (ART) adherence can be impacted by comorbidities such as mental health and substance use. Technology use has shown promise in increasing access to mental health and substance use services. Using a mixed-methods approach, we conducted formative research to describe the relationship between mental health, substance use, and medication adherence in 18-29 year-old YLWH, and explored technology use as an approach to supporting these services. Among 101 YLWH, ART adherence was significantly negatively associated with mental health measures such as depression, trauma, and adverse childhood experiences and marijuana and stimulants use. Depression had the highest level of relative importance in its association with ART adherence. During in-depth interviews with 29 participants, barriers to and facilitators of accessing and maintaining mental health services were identified. Most participants favored technology use for mental health and substance use service delivery, including videoconferencing with a counselor. Provision of ongoing mental health and substance use treatment is an important mechanism to achieving HIV treatment engagement. Technology, particularly videoconferencing, may have the capacity to overcome many barriers to care by increasing accessibility of these services.

Overcoming Technological Challenges: Lessons Learned from a Telehealth Counseling Study.

Background: Telehealth methods, including video chat counseling, have been growing in popularity within the behavioral health counseling field for over a decade. While video-based counseling methods have been shown to be effective and convenient, they have unique challenges stemming from the technology they use. Technical challenges can negatively impact appointment flow, intervention effectiveness, and the satisfaction of both patients and clinicians. Methodology: The Y2TEC (Youth to Text or Telehealth for Engagement in HIV Care) study is a pilot randomized control trial examining the feasibility and acceptability of a video counseling series provided to young adults (ages 18-29) living with HIV. The study's clinicians provided about 500 video-based counseling sessions through the Zoom videoconferencing platform. The study team then developed recommendations for overcoming technical challenges through a review of the best practice literature, insights from the clinicians and study coordinator, engaging in consultations during supervision meetings, receiving verbal feedback from participants, and reviewing logs of technical challenges. Results: Through our experience, we have found that quality of video-based counseling services can be greatly improved with minor intentional technological modifications in preparation and provision of services. We provide an overview of common challenges and corresponding recommendations to address them. Conclusion: This article can help clinicians improve their quality of telehealth sessions by identifying several common technological challenges that can occur during video chat sessions, exploring the impact of these challenges on session dynamics and providing concise, best practice-based recommendations to mitigate these issues that clinicians face.

Telehealth and texting intervention to improve HIV care engagement, mental health and substance use outcomes in youth living with HIV: a pilot feasibility and acceptability study protocol.

INTRODUCTION: Youth and young adults living with HIV (YLWH) experience worse clinical outcomes than adults and high rates of behavioural health challenges that impact their engagement in care and adherence to antiretroviral therapy. This study in the San Francisco Bay area aims to evaluate the feasibility, acceptability and preliminary clinical outcomes of a 12-session telehealth counselling series provided to 80 YLWH, including education, motivational enhancement and problem-solving around HIV care, mental health, substance use and other challenges. Findings will provide information about benefits and challenges of telehealth counselling for YLWH and will guide the development of new technology-based strategies for care. METHODS AND ANALYSIS: The Youth to Telehealth and Text to Improve Engagement in Care study is a pilot randomised, crossover trial examining the feasibility and acceptability of a telehealth counselling intervention consisting of twelve 20-30 min weekly sessions focused on identifying and problem-solving around barriers to HIV care access and adherence and on addressing mental health, substance use and/or other issues. Participants also receive text messages for check-ins, appointment reminders and to improve engagement. Participants complete quantitative online surveys at baseline, 4 and 8 months and qualitative exit interviews. Clinical outcomes, including plasma HIV RNA and CD4+ cell count, are collected from medical records. Study staff will explore outcomes of the intervention using quantitative and qualitative methods. ETHICS AND DISSEMINATION: This study and its protocols have been approved by the University of California, San Francisco (UCSF) Institutional Review Board. Study staff will work with the UCSF Center for AIDS Prevention Studies' Community Engagement Core and the Youth Advisory Panel to disseminate results to the community, participants and the academic community. TRIAL REGISTRATION: NCT03681145.

Fair hearing outcomes of patients recommended discharge from methadone maintenance.

A system known as fair hearings is a due process opportunity for patients who are involuntarily discharged from methadone maintenance treatment to challenge the discharge recommendation. We know very little about the processes and outcomes of fair hearings. For this study, we used a mixed methods approach to retrospectively analyze 73 fair hearing reports that were documented from a California methadone maintenance treatment program between 2000 and 2014. The aims of the study were to identify the reasons for involuntary discharge recommendation from methadone maintenance, describe the factors involved when fair hearing outcomes decided in favor of the clinic, and describe the factors involved when fair hearing outcomes decided in favor of the patient. We found that patient attendance at the fair hearing meeting was significantly related to the outcome ruling in favor of the patient. We organized the reasons for discharge recommendations into five categories: 1) suspected diversion, 2) behavioral/interpersonal, 3) repeated, unexcused absences, 4) co-occurring substance use, and 5) multiple sources of opioids. For each category, we use excerpts from fair hearing reports to provide context to the circumstances involved in an outcome favoring the patient or the clinic.

A Pilot Study of a Readiness Group to Increase Initiation of Smoking Cessation Services among Women in Residential Addiction Treatment.

This study implemented a smoking cessation readiness group (RG) in two women-focused residential substance abuse treatment programs, with the aim of engaging women in smoking cessation services. The primary outcome was defined as attending at least one cessation group after the RG ended. The RG combined features of the Expert Systems (ES) approach with a practice quit attempt. ES is an interactive system which tailors intervention to the smokers' stage of change, while the practice quit attempt rehearses the process of quitting smoking. As a secondary aim we tested whether incentives, used to promote participation and engagement in the RG, would increase initiation of smoking cessation services. Participants (N=75) were women smokers enrolled in two residential programs, and intention to quit smoking was not required for participation. Twelve participant cohorts were randomly assigned to receive the RG with or without incentives. Following the RG intervention, 38.7% of participants (n=29) attended at least one smoking cessation session. Both the number of RG sessions attended and a successful practice quit attempt predicted the later use of cessation services, while incentives did not. From pre- to post-RG, participants reported decreased cigarettes per day (CPD: 11.8 vs. 7.6, p<.0001) and decreased nicotine dependence as measured by the Heaviness Smoking Index (HSI: 2.3 vs. 1.8, p<.001). The 3-session group-format RG intervention was associated with initiation of smoking cessation services and with changes in smoking behavior.

Uptake of HIV testing in substance use disorder treatment programs that offer on-site testing.

Increasing rates of HIV testing within substance use disorder (SUD) treatment clients is an important public health strategy for reducing HIV transmission rates. The present study 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. 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.

Community-based harm reduction substance abuse treatment with methamphetamine-using men who have sex with men.

Harm reduction approaches endeavor to assist individuals with avoiding the most detrimental consequences of risk taking behaviors, but limited research has documented the outcomes of harm reduction substance abuse treatment. In total, 211 methamphetamine-using men who have sex with men (MSM) enrolled in two outcome studies of substance abuse treatment programs that were implementing an evidence-based, cognitive-behavioral intervention (i.e., the Matrix Model) from a harm reduction perspective. Study 1 (N = 123) examined changes in self-reported substance use, Addiction Severity Index (ASI) composite scores, and HIV care indicators over a 12-month follow-up. Study 2 (N = 88) assessed changes in substance use, sexual risk taking, and HIV care indicators over a 6-month follow-up. Participants in study 1 reported reductions in cocaine/crack use as well as decreases in the ASI drug and employment composite scores. Among HIV-positive participants in study 1 (n = 75), 47 % initiated or consistently utilized anti-retroviral therapy and this was paralleled by significant increases in self-reported undetectable HIV viral load. Study 2 participants reported reductions in methamphetamine use, erectile dysfunction medication use in combination with other substances, and sexual risk-taking behavior while using methamphetamine. Participants in both studies reported concurrent increases in marijuana use. Taken together, these studies are among the first to observe that clients may reduce stimulant use and concomitant sexual risk-taking behavior during harm reduction substance abuse treatment. Randomized controlled trials are needed to examine the differential effectiveness of harm reduction and abstinence-based approaches to substance abuse treatment.

Interaction of disulfiram with antiretroviral medications: efavirenz increases while atazanavir decreases disulfiram effect on enzymes of alcohol metabolism.

BACKGROUND AND OBJECTIVES: Alcohol abuse complicates treatment of HIV disease and is linked to poor outcomes. Alcohol pharmacotherapies, including disulfiram (DIS), are infrequently utilized in co-occurring HIV and alcohol use disorders possibly related to concerns about drug interactions between antiretroviral (ARV) medications and DIS. METHOD: This pharmacokinetics study (n=40) examined the effect of DIS on efavirenz (EFV), ritonavir (RTV), or atazanavir (ATV) and the effect of these ARV medications on DIS metabolism and aldehyde dehydrogenase (ALDH) activity which mediates the DIS-alcohol reaction. RESULTS: EFV administration was associated with decreased S-Methyl-N-N-diethylthiocarbamate (DIS carbamate), a metabolite of DIS (p=.001) and a precursor to the metabolite responsible for ALDH inhibition, S-methyl-N,N-diethylthiolcarbamate sulfoxide (DETC-MeSO). EFV was associated with increased DIS inhibition of ALDH activity relative to DIS alone administration possibly as a result of EFV-associated induction of CYP 3A4 which metabolizes the carbamate to DETC-MeSO (which inhibits ALDH). Conversely, ATV co-administration reduced the effect of DIS on ALDH activity possibly as a result of ATV inhibition of CYP 3A4. DIS administration had no significant effect on any ARV studied. DISCUSSION/CONCLUSIONS: ATV may render DIS ineffective in treatment of alcoholism. FUTURE DIRECTIONS: DIS is infrequently utilized in HIV-infected individuals due to concerns about adverse interactions and side effects. Findings from this study indicate that, with ongoing clinical monitoring, DIS should be reconsidered given its potential efficacy for alcohol and potentially, cocaine use disorders, that may occur in this population.

Interactions between alcohol and the HIV entry inhibitor Maraviroc.

BACKGROUND: Alcohol use is common among people with HIV, and beliefs about alcohol interactions with medications predict decreased medication adherence, risking drug-resistant mutations. Maraviroc is an HIV entry inhibitor approved for treatment of both drug-sensitive and drug-resistant HIV strains. The present study evaluated the effects of alcohol on maraviroc pharmacokinetics and the effects of maraviroc on alcohol pharmacokinetics. METHODS: Ten healthy adults completed alcohol (1 g/kg) and placebo alcohol pharmacokinetics sessions before and after 7 days of maraviroc administration. RESULTS: Alcohol concentrations increased 12% following maraviroc. Maraviroc pharmacokinetics were unaffected by alcohol. CONCLUSIONS: Maraviroc treatment should not be interrupted if alcohol is consumed.

Interactions between alcohol and the antiretroviral medications ritonavir or efavirenz.

OBJECTIVE: Alcohol abuse occurs frequently in those with human immunodeficiency virus (HIV) infection. Alcohol has been linked to poor response to HIV treatment and more rapid progression of HIV. One possible contributor to such observations is drug interactions between alcohol and antiretroviral (ARV) medications. This study examined drug interactions between antiretroviral therapies (ARTs) containing either efavirenz or ritonavir with alcohol. METHODS: Human immunodeficiency virus-infected individuals not currently receiving ARTs participated in a randomized, double-blind, placebo-controlled study in which alcohol (or placebo) was administered and followed by blood sampling for pharmacokinetics, subjective, cardiovascular, and neuropsychological responses obtained at predetermined times. Antiretroviral therapy was then initiated and alcohol (or placebo) sessions were repeated after at least 2 weeks of observed ART. RESULTS: Blood alcohol concentrations (BAC) were lower after ART in a pattern consistent with decreased bioavailability. No effect of alcohol on ritonavir or efavirenz pharmacokinetics was observed. A pharmacodynamic interaction between alcohol and efavirenz was observed as evidenced by no change in intoxication or drowsiness before and after efavirenz ART despite lower BAC. CONCLUSIONS: These results show the effectiveness of implementing ART and its role in diminution of BAC, which could be associated with decreased risk of physiological toxicities related to alcohol consumption relative to those with untreated HIV infection. A potential pharmacodynamic interaction between alcohol and efavirenz was observed as demonstrated by a lack of decline in ratings of intoxication and drowsiness despite decreased BAC. Alcohol consumption did not alter the pharmacokinetics of ritonavir or efavirenz.

Directly administered antiretroviral therapy: pilot study of a structural intervention in methadone maintenance.

Devising interventions to provide integrated treatment for addiction and medical problems is an urgent issue. This study piloted a structural intervention, Directly Administered Antiretroviral Therapy (DAART), to assist methadone-maintenance patients in HIV medication adherence. Twenty-four participants received: (1) antiretroviral medications at the methadone clinic daily before receiving their methadone; (2) take-home antiretroviral medication for days they were not scheduled to attend the methadone clinic, and (3) brief adherence counseling to address adherence barriers. DAART lasted 24 weeks, with a planned step-down to twice-weekly administration in weeks 25-36, followed by self-administration in weeks 37-48. Retention rates at weeks 24, 36, and 48 were 83, 92, and 75% respectively. DAART was associated with improvement in the proportion of participants achieving viral suppression as well as with high medication adherence rates (clinic-verified; 85% and self-reported 97%) during the active intervention phase. DAART was effective as an intervention but did not promote transition to self-administration. This study demonstrates that DAART is adaptable and simple enough to be implemented into methadone treatment programs interested in providing HIV adherence services.

Untreated HIV infection is associated with higher blood alcohol levels.

BACKGROUND: Alcohol abuse has been associated with HIV/AIDS progression, but the effects of HIV infection and treatment on alcohol exposure have not been explored to date. This pilot study examines the relationship of untreated HIV infection to blood alcohol concentrations (BAC) relative to BAC after initiation of antiretroviral therapy (ART). METHODS: Fifteen volunteers with untreated HIV/AIDS participated in 2 sets of alcohol or alcohol placebo administration studies before and after initiation of ART. Oral alcohol (1 g/kg) or alcohol placebo was administered, participants were followed for pharmacokinetics, subjective responses, and cognitive effects over 8 hours. After initial alcohol studies, the ART regimen selected by participant clinicians was instituted. Observed ART dosing took place for at least 2 weeks. Participants then returned for a second set of alcohol/placebo administration studies while on ART. RESULTS: Participants had significantly higher BAC (P < 0.001) before ART than after ART administration. Alcohol area under the curve was significantly higher in untreated HIV disease (P = 0.011) with significantly higher C(max) (P = 0.015) and C(min) (P = 0.05). The elimination rate was not different between pre-ART and post-ART conditions. Despite declines in BAC after ART initiation, no differences in subjective responses were observed with alcohol administration. CONCLUSIONS: Untreated HIV infection is associated with risk for higher BAC than that observed after ART. These findings indicate that patients with untreated HIV disease who ingest alcohol are at greater risk for alcohol associated adverse events and toxicities and underscores the need for simultaneous treatment of alcohol use disorders and HIV in patients with co-occurring conditions.

Interactions between buprenorphine and the protease inhibitors darunavir-ritonavir and fosamprenavir-ritonavir.

BACKGROUND: This study examined drug interactions between buprenorphine, a partial opioid agonist used for opioid dependence treatment and pain management, and the protease inhibitors (PIs) darunavir-ritonavir and fosamprenavir-ritonavir. METHODS: The pharmacokinetics of buprenorphine and its metabolites and symptoms of opioid withdrawal or excess were compared in opioid-dependent, buprenorphine-naloxone-maintained, human immunodeficiency virus (HIV)-negative volunteers (11 for darunavir-ritonavir and 10 for fosamprenavir-ritonavir) before and after 15 days of PI administration. PI pharmacokinetics and adverse effects were compared between the buprenorphine-maintained participants and an equal number of sex-, age-, race-, and weight-matched, healthy, non-opioid-dependent volunteers who received darunavir-ritonavir or fosamprenavir-ritonavir but not buprenorphine. RESULTS: There were no significant changes in buprenorphine or PI plasma levels and no significant changes in medication adverse effects or opioid withdrawal. Increased concentrations of the inactive metabolite buprenorphine-3-glucuronide suggested that darunavir-ritonavir and fosamprenavir-ritonavir induced glucuronidation of buprenorphine. CONCLUSIONS: Dose adjustments are not likely to be necessary when buprenorphine and darunavir-ritonavir or fosamprenavir-ritonavir are coadministered for the treatment of opioid dependence and HIV disease.