Opening the "black box": Four common implementation strategies for expanding the use of medications for opioid use disorder in primary care.

Background: Despite the persistent increase in overdose deaths, access to medications for opioid use disorders remains limited. Recent federal funding aimed at increasing access prompts a need to understand if implementation strategies improve access.

Methods: This is an analysis of data from 174 primary care clinics enrolled in a state-wide medications for opioid use disorders (MOUD) implementation effort in California.

Implementation of the hub and spoke model for opioid use disorders in California: Rationale, design and anticipated impact.

As part of the State Targeted Response to the opioid epidemic, California has adopted the Hub and Spoke model to expand access to medications for opioid use disorder, particularly buprenorphine, throughout the state. By aligning opioid treatment programs as hubs with primary care, office-based practitioners, and other health care settings as spokes, a broader treatment model can reach more people with opioid use disorder, improve access to medications for opioid use disorders, and decrease overdose deaths. Expanding access requires expanding knowledge and intensive implementation support of new practices.

Using e-technologies in clinical trials.

Clinical trials have been slow to incorporate e-technology (digital and electronic technology that utilizes mobile devices or the Internet) into the design and execution of studies. In the meantime, individuals and corporations are relying more on electronic platforms and most have incorporated such technology into their daily lives. This paper provides a general overview of the use of e-technologies in clinical trials research, specifically within the last decade, marked by rapid growth of mobile and Internet-based tools.

The Use of Technology in Participant Tracking and Study Retention: Lessons Learned From a Clinical Trials Network Study.

Background: The growing use of newer communication and Internet technologies, even among low-income and transient populations, require research staff to update their outreach strategies to ensure high follow-up and participant retention rates. This paper presents the views of research assistants on the use of cell phones and the Internet to track participants in a multisite randomized trial of substance use disorder treatment.

Methods: Preinterview questionnaires exploring tracking and other study-related activities were collected from 21 research staff across the 10 participating US sites.

Gender-based Outcomes and Acceptability of a Computer-assisted Psychosocial Intervention for Substance Use Disorders.

Background: Digital technologies show promise for increasing treatment accessibility and improving quality of care, but little is known about gender differences. This secondary analysis uses data from a multi-site effectiveness trial of a computer-assisted behavioral intervention, conducted within NIDA's National Drug Abuse Clinical Trials Network, to explore gender differences in intervention acceptability and treatment outcomes.

Methods: Men (n=314) and women (n=192) were randomly assigned to 12-weeks of treatment-as-usual (TAU) or modified TAU+Therapeutic Education System (TES), whereby TES substituted for 2hours of TAU per week.

Acceptability of a web-based community reinforcement approach for substance use disorders with treatment-seeking American Indians/Alaska Natives.

Longstanding disparities in substance use disorders and treatment access exist among American Indians/Alaska Natives (AI/AN). Computerized, web-delivered interventions have potential to increase access to quality treatment and improve patient outcomes. Prior research supports the efficacy of a web-based version [therapeutic education system (TES)] of the community reinforcement approach to improve outcomes among outpatients in substance abuse treatment; however, TES has not been tested among AI/AN.

Racial/ethnic match and treatment outcomes for women with PTSD and substance use disorders receiving community-based treatment.

This study examined the relationship between racial/ethnic match and treatment outcomes for 224 women who participated in a clinical trial of group treatments for posttraumatic stress disorder (PTSD) and substance use disorders. Generalized estimating equations were used to examine the effect of client-therapist racial/ethnic match on outcomes. Results revealed racial/ethnic match was not significantly associated with session attendance.

Internet-delivered treatment for substance abuse: a multisite randomized controlled trial.

Objective: Computer-delivered interventions have the potential to improve access to quality addiction treatment care. The objective of this study was to evaluate the effectiveness of the Therapeutic Education System (TES), an Internet-delivered behavioral intervention that includes motivational incentives, as a clinician-extender in the treatment of substance use disorders.

Method: Adult men and women (N=507) entering 10 outpatient addiction treatment programs were randomly assigned to receive 12 weeks of either treatment as usual (N=252) or treatment as usual plus TES, with the intervention substituting for about 2 hours of standard care per week (N=255).

Web-based, psychosocial treatment for substance use disorders in community treatment settings.

The purpose of this multisite clinical trial was to evaluate the effectiveness of a web-based version of the Community Reinforcement Approach, plus motivational incentives, within community-based, outpatient substance abuse treatment. This ongoing study is being conducted within the National Drug Abuse Treatment Clinical Trials Network, funded by the National Institute on Drug Abuse. Midway through the enrollment of 500 participants, the study is being implemented in 10 treatment programs across the United States.

Helping alliance, retention, and treatment outcomes: a secondary analysis from the NIDA Clinical Trials Network Women and Trauma Study.

We examined the association between the therapeutic alliance and treatment outcomes among 223 women with posttraumatic stress disorder (PTSD) and substance use disorders who participated in a multisite clinical trial of group treatments for trauma and addictions in the United States throughout 2004 and 2005. General linear models indicated that women who received Seeking Safety, a cognitive-behavioral treatment, had significantly higher alliance ratings than those in Women's Health Education, a control group. Alliance was related to significant decreases in PTSD symptoms and higher attendance in both interventions.

Design and methodological considerations of an effectiveness trial of a computer-assisted intervention: an example from the NIDA Clinical Trials Network.

Computer-assisted interventions hold the promise of minimizing two problems that are ubiquitous in substance abuse treatment: the lack of ready access to treatment and the challenges to providing empirically-supported treatments. Reviews of research on computer-assisted treatments for mental health and substance abuse report promising findings, but study quality and methodological limitations remain an issue. In addition, relatively few computer-assisted treatments have been tested among illicit substance users.

Baseline matters: the importance of covariation for baseline severity in the analysis of clinical trials.

Background: Clinical trials testing the effectiveness of interventions for addictions, HIV transmission risk, and other behavioral health problems are important to advancing evidence-based treatment. Such trials are expensive and time-consuming to conduct, but the underlying effect sizes tend to be modest, and often findings are disappointing, failing to show evidence of treatment effects.

Objectives: To demonstrate how appropriate covariation for baseline severity can enhance detection of treatment effects.

Gender research in the National Institute on Drug Abuse National Treatment Clinical Trials Network: a summary of findings.

Background: The National Institute of Drug Abuse's National Drug Abuse Treatment Clinical Trials Network (CTN) was established to foster translation of research into practice in substance abuse treatment settings. The CTN provides a unique opportunity to examine in multi-site, translational clinical trials, the outcomes of treatment interventions targeting vulnerable subgroups of women; the comparative effectiveness of gender-specific protocols to reduce risk behaviors; and gender differences in clinical outcomes.

Objectives: To review gender-related findings from published CTN clinical trials and related studies from January 2000 to March 2010.

NIDA's Clinical Trials Network: an opportunity for HIV research in community substance abuse treatment programs.

Background/objectives: HIV continues to be a significant problem among substance users and their sexual partners in the United States. The National Drug Abuse Treatment Clinical Trials Network (CTN) offers a national platform for effectiveness trials of HIV interventions in community substance abuse treatment programs. This article presents the HIV activities of the CTN during its first 10 years.

Community Providers' Impression of HIV Prevention Intervention Research in NIDA's Clinical Trials Network.

Research-based approaches to HIV risk reduction are available but not readily adopted by community-based treatment programs. This exploratory survey study assessed staff (N=116) attitudes as a function of direct research participation, treatment program type, and study performance within seven methadone maintenance and eight psychosocial outpatient substance abuse treatment programs that participated in the NIDA Clinical Trials Network HIV risk reduction trials. Clinical staff who directly participated in the research reported intervention components as useful and were more likely to report perceived increases in HIV testing/referrals compared to staff who did not directly participate.

Do treatment improvements in PTSD severity affect substance use outcomes? A secondary analysis from a randomized clinical trial in NIDA's Clinical Trials Network.

Objective: The purpose of the analysis was to examine the temporal course of improvement in symptoms of posttraumatic stress disorder (PTSD) and substance use disorder among women in outpatient substance abuse treatment.

Method: Participants were 353 women randomly assigned to 12 sessions of either trauma-focused or health education group treatment. PTSD and substance use assessments were conducted during treatment and posttreatment at 1 week and after 3, 6, and 12 months.

Multisite randomized trial of behavioral interventions for women with co-occurring PTSD and substance use disorders.

The authors compared the effectiveness of the Seeking Safety group, cognitive-behavioral treatment for substance use disorder and posttraumatic stress disorder (PTSD), to an active comparison health education group (Women's Health Education [WHE]) within the National Institute on Drug Abuse's Clinical Trials Network. The authors randomized 353 women to receive 12 sessions of Seeking Safety (M = 6.2 sessions) or WHE (M = 6.

The impact of trauma-focused group therapy upon HIV sexual risk behaviors in the NIDA Clinical Trials Network "Women and trauma" multi-site study.

Women in drug treatment struggle with co-occurring problems, including trauma and post-traumatic stress disorder (PTSD), which can heighten HIV risk. This study examines the impact of two group therapy interventions on reduction of unprotected sexual occasions (USO) among women with substance use disorders (SUD) and PTSD. Participants were 346 women recruited from and receiving treatment at six community-based drug treatment programs participating in NIDA's Clinical Trials Network.

Effectiveness of HIV/STD sexual risk reduction groups for women in substance abuse treatment programs: results of NIDA Clinical Trials Network Trial.

Context: Because drug-involved women are among the fastest growing groups with AIDS, sexual risk reduction intervention for them is a public health imperative.

Objective: To test effectiveness of HIV/STD safer sex skills building (SSB) groups for women in community drug treatment.

Design: Randomized trial of SSB versus standard HIV/STD Education (HE); assessments at baseline, 3 and 6 months.

Training and fidelity monitoring of behavioral interventions in multi-site addictions research.

Aims: Methods for the training and fidelity monitoring of behavioral interventions in multi-site addictions research are reviewed, including five published studies and seven ongoing studies sponsored by the National Institute on Drug Abuse-funded Clinical Trials Network.

Methods: Methods are categorized and reviewed consistent with a technology model of treatment delivery. Topics include: therapist selection, training, certification, and supervision; selection, training, and certification of supervisors; scales and processes used for monitoring of the quality of treatment; and processes followed to provide new training for replacement staff once trials have begun.

Substance abuse treatment entry, retention, and outcome in women: a review of the literature.

This paper reviews the literature examining characteristics associated with treatment outcome in women with substance use disorders. A search of the English language literature from 1975 to 2005 using Medline and PsycInfo databases found 280 relevant articles. Ninety percent of the studies investigating gender differences in substance abuse treatment outcomes were published since 1990, and of those, over 40% were published since the year 2000.

Promising treatments for women with comorbid PTSD and substance use disorders.

Objective: The authors' goal was to compare the efficacy of a manualized cognitive behavior therapy that addresses both posttraumatic stress disorder (PTSD) and substance abuse (seeking safety) with a manualized cognitive behavior therapy that addresses only substance abuse (relapse prevention) and with standard community care for the treatment of comorbid posttraumatic stress disorder (PTSD) and substance use disorder.

Method: One hundred seven women from an urban, low-income population who had comorbid PTSD and substance use disorder were randomly assigned to receive the two kinds of cognitive behavior therapy or received standard community treatment. Participants were recruited from both community and clinical populations and evaluated with structured clinical instruments.

Emotion-focused coping as a mediator of maternal cocaine abuse and antisocial behavior.

A great deal of data implicate parental drug use as a potential risk factor for child abuse; however, theories for understanding the links between maternal drug use and antisocial behavior have yet to be examined empirically. This case-control study investigated correlates of adult antisocial behavior among 279 inner-city mothers in 3 comparison groups: drug abusers (n = 112), depressed mothers (n = 73), and nonsubstance abusing controls (n = 94). Using hierarchical regression techniques and mediational analyses controlling for ethnicity, current depression, and family history of substance abuse, support was provided for an emotion-focused coping style as a link between addictive and antisocial behavior.