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Clinicians and researchers alike are increasingly interested in how best to personalize interventions. A dynamic treatment regimen is a sequence of prespecified decision rules which can be used to guide the delivery of a sequence of treatments or interventions that is tailored to the changing needs of the individual. The sequential multiple-assignment randomized trial is a research tool which allows for the construction of effective dynamic treatment regimens. We derive easy-to-use formulae for computing the total sample size for three common two-stage sequential multiple-assignment randomized trial designs in which the primary aim is to compare mean end-of-study outcomes for two embedded dynamic treatment regimens which recommend different first-stage treatments. The formulae are derived in the context of a regression model which leverages information from a longitudinal outcome collected over the entire study. We show that the sample size formula for a sequential multiple-assignment randomized trial can be written as the product of the sample size formula for a standard two-arm randomized trial, a deflation factor that accounts for the increased statistical efficiency resulting from a longitudinal analysis, and an inflation factor that accounts for the design of a sequential multiple-assignment randomized trial. The sequential multiple-assignment randomized trial design inflation factor is typically a function of the anticipated probability of response to first-stage treatment. We review modeling and estimation for dynamic treatment regimen effect analyses using a longitudinal outcome from a sequential multiple-assignment randomized trial, as well as the estimation of standard errors. We also present estimators for the covariance matrix for a variety of common working correlation structures. Methods are motivated using the ENGAGE study, a sequential multiple-assignment randomized trial aimed at developing a dynamic treatment regimen for increasing motivation to attend treatments among alcohol- and cocaine-dependent patients. [ABSTRACT FROM AUTHOR]

Sequential, multiple assignment, randomized trial (SMART) designs have become increasingly popular in the field of precision medicine by providing a means for comparing more than two sequences of treatments tailored to the individual patient, i.e., dynamic treatment regime (DTR). The construction of evidence-based DTRs promises a replacement to ad hoc one-size-fits-all decisions pervasive in patient care. However, there are substantial statistical challenges in sizing SMART designs due to the correlation structure between the DTRs embedded in the design (EDTR). Since a primary goal of SMARTs is the construction of an optimal EDTR, investigators are interested in sizing SMARTs based on the ability to screen out EDTRs inferior to the optimal EDTR by a given amount which cannot be done using existing methods. In this article, we fill this gap by developing a rigorous power analysis framework that leverages the multiple comparisons with the best methodology. Our method employs Monte Carlo simulation to compute the number of individuals to enroll in an arbitrary SMART. We evaluate our method through extensive simulation studies. We illustrate our method by retrospectively computing the power in the Extending Treatment Effectiveness of Naltrexone (EXTEND) trial. An R package implementing our methodology is available to download from the Comprehensive R Archive Network. [ABSTRACT FROM AUTHOR]

Background: The perceived benefits of drug use are not currently integrated into the treatment of substance use disorder. This omission appears paradoxical and is unsubstantiated by empirical research. As the perceived benefits of drug use are catalysts for drug initiation, relapse and continuous use, increased knowledge about these benefits seems crucial to efficacious treatment. Aims: To investigate the perceived benefits of drug use in substance use disorder. Method: The study is a phenomenological-hermeneutical investigation using thematic analysis of interviews with 30 long-term recovered adult service users. Results: Our thematic analysis resulted in three themes and several sub-themes: (1) Benefits of drug use; (2) Necessity of intense experiences; and (3) Importance of being unconventional. Conclusions: Findings indicate that the benefits of non-problematic and problematic drug use are motivated by similar individual and social needs. An absolute distinction between problematic and non-problematic drug use thus seems arbitrary and potentially counterproductive for clinical practice. The benefits of drug use should be researched as a possible add-on treatment module, as this knowledge may be of significant clinical value in treatment frameworks. [ABSTRACT FROM AUTHOR]

Objective: To critically review the methodologies used to study relapse in substance abusers and compare some of the findings these methodologies have produced. Method: Representative studies that have used retrospective, prospective, or near real time methodologies to study antecedents or consequences of relapse are presented and the strengths and weaknesses of each methodology are reviewed. Limitations in the ability of substance abusers to accurately report internal states are considered. Degree of convergence in findings across methodologies is examined. Results: Retrospective reports can provide perhaps the most detailed accounts of circumstances and experiences leading up to relapse, but are also more likely to be inaccurate due to the limitations of memory. Prospective studies are less likely to be affected by memory problems, but may not capture factors that immediately precede relapse. The near real time methodology, which uses palm-top computers to gather data, has many advantages over other methodologies, but a number of limitations as well. The two studies in which retrospective reports were directly compared to either prospective or near real time reports yielded mixed results regarding degree of agreement. Findings from several areas of research suggest that some substance abusers may have difficulty recognizing and reporting internal states. Conclusions: Despite memory problems and other limitations of self-report, all three methodologies have produced findings that implicate negative affect states, increased craving, cognitive factors, interpersonal problems, and lack of coping as factors in relapse. Future relapse studies should make use of all three methodologies to obtain data on relapse and consequences, and steps should be taken to enhance the accuracy of the self-reports that are gathered with each method. (J. Stud. Alcohol 60: 566-576, 1999), ONE OF THE MORE distressing problems in substance abuse treatment is the relatively high rate of relapse to alcohol, drug, or nicotine use following periods of abstinence. Although specific criteria [...]

Background: We estimated the efficacy of the Addiction-Comprehensive Health Enhancement Support System (A-CHESS) in increasing the use of services for addiction and examined the extent to which this use of services mediated the effects of A-CHESS on risky drinking days and abstinence from drinking.Methods: We conducted secondary data analyses of the A-CHESS randomized controlled trial. Recruitment occurred in five residential treatment programs operated by two addiction treatment organizations. Participants were 349 adults with alcohol use disorders recruited two weeks before discharge from residential treatment. We provided intervention arm participants with a smartphone, the A-CHESS application, and an 8-month service plan. Control arm participants received treatment as usual. Telephone interviews at 4, 8, and 12-month follow-ups assessed past-month risky drinking days, past-month abstinence, and post-discharge service utilization (past-month outpatient addiction treatment and past-week mutual help including Alcoholics Anonymous and Narcotics Anonymous). Using mixed effects latent variable models, we estimated the indirect effects of A-CHESS on drinking outcomes, as mediated by post-discharge service utilization.Results: Approximately 50.5% of participants reported outpatient addiction treatment and 75.5% reported mutual help at any follow-up interview in the year following randomization. Assignment to the A-CHESS intervention was associated with an increased odds of outpatient addiction treatment across follow-ups, but not mutual help. This use of outpatient addiction treatment mediated the effect of A-CHESS on risky drinking days, but not abstinence. The effect of A-CHESS through outpatient addiction treatment appeared to reduce the expected number of risky drinking days across follow-ups by 11%.Conclusions: The mobile health (mHealth) intervention promoted the use of outpatient addiction treatment, which appeared to contribute to its efficacy in reducing risky drinking. Future research should investigate how mHealth interventions could link patients to needed treatment services and promote the sustained use of these services. [ABSTRACT FROM AUTHOR]

Background Research has led to improvements in the effectiveness of interventions for substance use disorders (SUD), but for the most part progress has been modest, particularly with regard to longer-term outcomes. Moreover, most individuals with SUD do not seek out treatment. Argument/analysis This paper presents two recommendations on how to improve treatment engagement and long-term outcomes for those with SUD. First, treatments should go beyond a focus on reducing or eliminating substance use to target greater access to and more time spent in experiences that will be enjoyable or otherwise rewarding to clients. Secondly, there must be sufficient incentives in the environment to justify the effort needed to sustain long-term abstinence for individuals who often have limited access to such incentives. Conclusions To increase rates of long-term recovery from substance misuse, treatments should link clients to reinforcers that will make continued abstinence more appealing. This work needs to extend beyond interventions focused on the individual or family to include the local community and national policy in an effort to incentivize longer-term recoveries more strongly. [ABSTRACT FROM AUTHOR]

Background: Intimate partnerships are discouraged during early recovery, despite research that highlights their capacity to be resources for change. Objective: This study seeks to provide descriptions of intimate partnerships and how such partnerships challenge and/or support minimizing HIV sex-risk among participants in continuing care for cocaine addiction in order to inform substance use programming. Methods: Forty-two recorded continuing care counseling sessions of 33 people who discussed HIV sex-risk behavior were transcribed and analyzed using thematic analysis. This sample was derived from a larger randomized controlled trial that looked at the impact of a continuing care intervention for people with cocaine use problems. Results: Although participants expressed the desire for a primary intimate partnership, casual intimate partnerships that often involved HIV sex-risk behavior were more prevalent. Challenges to having a primary intimate partner included the belief that intimate partnerships do not support recovery, difficulty in developing friendships with women among heterosexual men, and the ubiquity of drug use and sex work in home environments with limited economic opportunity. Despite these challenges, some participants reported having primary intimate partners that supported their recovery through open communication. Conclusion: Clinicians providing substance use interventions can consider encouraging components of intimate partnerships that support recovery. In addition, the strong environmental influence on individual HIV sex-risk behavior should be considered in delivering any substance use intervention. [ABSTRACT FROM AUTHOR]