Medication-assisted treatment of opioid use disorder: review of the evidence and future directions.

Medication-assisted treatment of opioid use disorder with physiological dependence at least doubles rates of opioid-abstinence outcomes in randomized, controlled trials comparing psychosocial treatment of opioid use disorder with medication versus with placebo or no medication. This article reviews the current evidence for medication-assisted treatment of opioid use disorder and also presents clinical practice imperatives for preventing opioid overdose and the transmission of infectious disease. The evidence strongly supports the use of agonist therapies to reduce opioid use and to retain patients in treatment, with methadone maintenance remaining the gold standard of care. Combined buprenorphine/naloxone, however, also demonstrates significant efficacy and favorable safety and tolerability in multiple populations, including youth and prescription opioid-dependent individuals, as does buprenorphine monotherapy in pregnant women. The evidence for antagonist therapies is weak. Oral naltrexone demonstrates poor adherence and increased mortality rates, although the early evidence looks more favorable for extended-release naltrexone, which has the advantages that it is not subject to misuse or diversion and that it does not present a risk of overdose on its own. Two perspectives-individualized treatment and population management-are presented for selecting among the three available Food and Drug Administration-approved maintenance therapies for opioid use disorder. The currently unmet challenges in treating opioid use disorder are discussed, as are the directions for future research.

Adolescent substance use and unplanned pregnancy: strategies for risk reduction.

Substance use among adolescents increases the risk of unplanned pregnancies, which then increases the risk of fetal exposure to addictive, teratogenic substances. Specific interventions are necessary to target pregnancy planning and contraception among reproductive-age substance users. Screening for substance use using the CRAFFT is recommended in all health care settings treating adolescent patients. Screening for tobacco and nicotine use is also recommended along with the provision of smoking cessation interventions. Using motivational interviewing style and strategies is recommended to engage adolescents in discussions related to reducing substance use, risky sexual behavior, and probability of unplanned pregnancy or late-detection pregnancy.

Effectiveness of alcohol treatment interventions integrated into routine tuberculosis care in Tomsk, Russia.

AIMS: To test the feasibility and effectiveness of brief counseling intervention (BCI) and naltrexone integrated into tuberculosis (TB) care in Tomsk, Russia. DESIGN: Using a factorial randomized controlled trial design, patients were randomized into: naltrexone (NTX), brief behavioral compliance enhancement therapy (BBCET), treatment as usual (TAU) and BCI. SETTING AND PARTICIPANTS: In the Tomsk Oblast, hospitalized TB patients diagnosed with alcohol use disorders (AUDs) by the DSM-IV were referred at the start of TB treatment. Of the 196 participants, the mean age was 41 years and 82% were male. Severe TB (84.7% had cavitary disease) and smoking (92.9%) were common. The majority had a diagnosis of an AUD (63.0%); 27.6% reported nearly daily drinking and consumed a median of 16 standard drinks per day. MEASUREMENTS: Primary outcomes were 'favorable' TB outcome (cured, completed treatment) and change in mean number of abstinent days in the last month of study compared with baseline. Change in mean number of heavy drinking days, defined as four drinks per day and five drinks per day for women and men, respectively, and TB adherence, measured as percentage of doses taken as prescribed under direct observation, were secondary outcomes. Analysis based on 'intention-to-treat' was performed for multivariable analysis. FINDINGS: Primary TB and alcohol end-points between naltrexone and no-naltrexone or BCI and no-BCI groups did not differ significantly. TB treatment adherence and change in number of heavy drinking days also did not differ significantly among treatment arms. Among individuals with a prior quitting attempt (n = 111), naltrexone use was associated with an increased likelihood of favorable TB outcomes (92.3% versus 75.9%, P = 0.02). CONCLUSIONS: In Tomsk Oblast, Russia, tuberculosis patients with severe alcohol use disorders who were not seeking alcohol treatment did not respond to naltrexone or behavioral counselling integrated into tuberculosis care; however, those patients with past attempts to quit drinking had improved tuberculosis outcomes.

Gender differences in a clinical trial for prescription opioid dependence.

Although gender differences in substance use disorders have been identified, few studies have examined gender differences in prescription drug dependence. The aim of this study was to examine gender differences in clinical characteristics and treatment outcomes in a large clinical trial for prescription opioid dependence. Despite no pre-treatment differences in opioid dependence severity, women reported significantly greater functional impairment, greater psychiatric severity, and higher likelihood of using opioids to cope with negative affect and pain than men. Women were also more likely than men to have first obtained opioids via a legitimate prescription and to use opioids via the intended route of administration. Men reported significantly more alcohol problems than women. There were no significant gender differences in medication dose, treatment retention, or opioid outcomes. Thus, despite the presence of pre-treatment gender differences in this population, once the study treatment was initiated, women and men exhibited similar opioid use outcomes.

A multi-site, two-phase, Prescription Opioid Addiction Treatment Study (POATS): rationale, design, and methodology.

The National Institute on Drug Abuse Clinical Trials Network launched the Prescription Opioid Addiction Treatment Study (POATS) in response to rising rates of prescription opioid dependence and gaps in understanding the optimal course of treatment for this population. POATS employed a multi-site, two-phase adaptive, sequential treatment design to approximate clinical practice. The study took place at 10 community treatment programs around the United States. Participants included men and women age > or =18 who met Diagnostic and Statistical Manual, 4th Edition criteria for dependence upon prescription opioids, with physiologic features; those with a prominent history of heroin use (according to pre-specified criteria) were excluded. All participants received buprenorphine/naloxone (bup/nx). Phase 1 consisted of 4 weeks of bup/nx treatment, including a 14-day dose taper, with 8 weeks of follow-up. Phase 1 participants were monitored for treatment response during these 12 weeks. Those who relapsed to opioid use, as defined by pre-specified criteria, were invited to enter Phase 2; Phase 2 consisted of 12 weeks of bup/nx stabilization treatment, followed by a 4-week taper and 8 weeks of post-treatment follow-up. Participants were randomized at the beginning of Phase 1 to receive bup/nx, paired with either Standard Medical Management (SMM) or Enhanced Medical Management (EMM; defined as SMM plus individual drug counseling). Eligible participants entering Phase 2 were re-randomized to either EMM or SMM. POATS was developed to determine what benefit, if any, EMM offers over SMM in short-term and longer-term treatment paradigm. This paper describes the rationale and design of the study.

Integrated Management of Physician-delivered Alcohol Care for Tuberculosis Patients: Design and Implementation.

BACKGROUND: While the integration of alcohol screening, treatment, and referral in primary care and other medical settings in the U.S. and worldwide has been recognized as a key health care priority, it is not routinely done. In spite of the high co-occurrence and excess mortality associated with alcohol use disorders (AUDs) among individuals with tuberculosis (TB), there are no studies evaluating effectiveness of integrating alcohol care into routine treatment for this disorder. METHODS: We designed and implemented a randomized controlled trial (RCT) to determine the effectiveness of integrating pharmacotherapy and behavioral treatments for AUDs into routine medical care for TB in the Tomsk Oblast Tuberculosis Service (TOTBS) in Tomsk, Russia. Eligible patients are diagnosed with alcohol abuse or dependence, are newly diagnosed with TB, and initiating treatment in the TOTBS with Directly Observed Therapy-Short Course (DOTS) for TB. Utilizing a factorial design, the Integrated Management of Physician-delivered Alcohol Care for Tuberculosis Patients (IMPACT) study randomizes eligible patients who sign informed consent into 1 of 4 study arms: (1) Oral Naltrexone + Brief Behavioral Compliance Enhancement Therapy (BBCET) + treatment as usual (TAU), (2) Brief Counseling Intervention (BCI) + TAU, (3) Naltrexone + BBCET + BCI + TAU, or (4) TAU alone. RESULTS: Utilizing an iterative, collaborative approach, a multi-disciplinary U.S. and Russian team has implemented a model of alcohol management that is culturally appropriate to the patient and TB physician community in Russia. Implementation to date has achieved the integration of routine alcohol screening into TB care in Tomsk; an ethnographic assessment of knowledge, attitudes, and practices of AUD management among TB physicians in Tomsk; translation and cultural adaptation of the BCI to Russia and the TB setting; and training and certification of TB physicians to deliver oral naltrexone and brief counseling interventions for alcohol abuse and dependence as part of routine TB care. The study is successfully enrolling eligible subjects in the RCT to evaluate the relationship of integrating effective pharmacotherapy and brief behavioral intervention on TB and alcohol outcomes, as well as reduction in HIV risk behaviors. CONCLUSIONS: The IMPACT study utilizes an innovative approach to adapt 2 effective therapies for treatment of alcohol use disorders to the TB clinical services setting in the Tomsk Oblast, Siberia, Russia, and to train TB physicians to deliver state of the art alcohol pharmacotherapy and behavioral treatments as an integrated part of routine TB care. The proposed treatment strategy could be applied elsewhere in Russia and in other settings where TB control is jeopardized by AUDs. If demonstrated to be effective, this model of integrating alcohol interventions into routine TB care has the potential for expanded applicability to other chronic co-occurring infectious and other medical conditions seen in medical care settings.

The relationship of self-esteem and self-efficacy to treatment outcomes of alcohol-dependent men and women.

This study investigates whether self-esteem is associated with clinical and demographic characteristics, self-efficacy expectancies, and post-treatment drinking outcomes. Forty-one (40.6%) women and 60 (59.4%) men were recruited during inpatient alcohol dependence treatment. At baseline, lower self-esteem was significantly associated with current depression and other psychiatric disorders. Self-esteem was not related to gender, relapse, other one-year drinking outcomes, or self-efficacy. Age and psychiatric disorders were strong predictors of self-esteem at follow-up. This study suggests that different perceptions of the self have unique roles in recovery from alcohol use disorders.

Further validation of the Psycho-Social Well-Being Scale (PSWS) with community clients.

To monitor and evaluate the use of evidence-based approaches with mentally ill persons who abuse alcohol and other drugs, administrators, practitioners and evaluators will need to incorporate brief, reliable, and valid instruments into daily practice. The current two-part study provides further validation of the Psycho-Social Wellbeing Scale (PSWS), a multidisciplinary "debriefing tool" designed to capture and summarize data on clients' wellbeing from multiple sources in team-based community care. In the current investigation the PSWS was correlated with a number of valid instruments including the Brief Psychiatric Rating Scale, the Role Functioning Scale, the Social Functioning-12, the Alcohol Use Disorders Identification Test, the Alcohol Use and Drug Use Scales along with other important indices. Results show strong evidence of internal consistency, concurrent and discriminant validity with these criterion variables. Regression modeling demonstrates that the two main subscales (psychological and social wellbeing) add significantly to a model predicting substance abuse problems.