Placebo group improvement in trials of pharmacotherapies for alcohol use disorders: a multivariate meta-analysis examining change over time.

OBJECTIVE: Placebo group improvement in pharmacotherapy trials has been increasing over time across several pharmacological treatment areas. However, it is unknown to what degree increasing improvement has occurred in pharmacotherapy trials for alcohol use disorders or what factors may account for placebo group improvement. This meta-analysis of 47 alcohol pharmacotherapy trials evaluated (1) the magnitude of placebo group improvement, (2) the extent to which placebo group improvement has been increasing over time, and (3) several potential moderators that might account for variation in placebo group improvement. METHOD: Random-effects univariate and multivariate analyses were conducted that examined the magnitude of placebo group improvement in the 47 studies and several potential moderators of improvement: (a) publication year, (b) country in which the study was conducted, (c) outcome data source/type, (d) number of placebo administrations, (e) overall severity of study participants, and (f) additional psychosocial treatment. RESULTS: Substantial placebo group improvement was found overall and improvement was larger in more recent studies. Greater improvement was found on moderately subjective outcomes, with more frequent administrations of the placebo, and in studies with greater participant severity of illness. However, even after controlling for these moderators, placebo group improvement remained significant, as did placebo group improvement over time. CONCLUSIONS: Similar to previous pharmacotherapy placebo research, substantial pretest to posttest placebo group improvement has occurred in alcohol pharmacotherapy trials, an effect that has been increasing over time. However, several plausible moderator variables were not able to explain why placebo group improvement has been increasing over time.

Teaching motivational interviewing to primary care staff in the Veterans Health Administration.

BACKGROUND: The Veterans Health Administration (VHA) is implementing the patient-centered medical home (PCMH) model of primary care which emphasizes patient-centered care and the promotion of healthy lifestyle changes. Motivational Interviewing (MI) is effective for promoting various health behaviors, thus a training protocol for primary care staff was implemented in a VHA health care setting. OBJECTIVES: We examined the effect of the training protocol on MI knowledge, confidence in ability to use MI-related skills and apply them to written vignettes, perceived comfort level and skill in lifestyle counseling, and job-related burnout. DESIGN: Training was provided by experts in MI. The training protocol consisted of three sessions--one half day in-person workshop followed by a 60-minute virtual training, followed by a second workshop. Each of the sessions were spaced two weeks apart and introduced trainees to the theory, principles, and skills of using MI in health care settings. PARTICIPANTS: All primary care staff at the Veterans Affairs Palo Alto Health Care System were invited to participate. MEASUREMENTS: Trainees completed a short set of questionnaires immediately before and immediately after the training. RESULTS: We found support for our primary hypotheses related to knowledge, confidence, and written responses to the vignettes. Changes in perceived comfort level and skill in lifestyle counseling, and job-related burnout were not observed. CONCLUSIONS: Training primary care staff in MI is likely to become increasingly common as health care systems transition to the PCMH model of care. Therefore, it is important for health care systems to have low-cost methods for evaluating the effectiveness of such trainings. This study is a first step in developing a brief written assessment with the potential of measuring change in a range of behaviors and skills consistent with MI.

Problem-free drinking over 16 years among individuals with alcohol use disorders.

BACKGROUND: Limited data exist on the rates and long-term stability of non-problem drinking in individuals who sought help for an alcohol use disorder. METHODS: A sample of initially untreated individuals with alcohol use disorders (n=420) was surveyed at baseline and 1 year and was re-assessed at 8 and 16 years. RESULTS: In the 6 months prior to the 1-year assessment, 36% (n=152) of participants reported abstinence from alcohol, 48% (n=200) reported drinking with problems, and 16% (n=68) reported non-problem drinking. At each follow up, 16-21% of the sample reported non-problem drinking. Compared to individuals in the abstinent and problem-drinking groups, individuals who were drinking in a problem-free manner at 1 year had reported, at baseline, fewer days of intoxication, drinks per drinking day, alcohol dependence symptoms, and alcohol-related problems, less depression, and more adaptive coping mechanisms. Over time, 48% of participants who engaged in non-problem drinking at 1 year continued to report positive outcomes (either non-problem drinking or abstinence) throughout the long-term follow-up, whereas 77% of those abstaining at 1 year reported positive outcomes throughout the same time period. Additionally, 43% of individuals with problematic alcohol consumption at 1 year reported positive outcomes over the remaining follow-up interval, a rate that was not significantly different from the rate of positive outcomes of 48% observed in those with initial problem-free drinking. CONCLUSIONS: Although some individuals report non-problem drinking a year after initially seeking help, this pattern of alcohol use is relatively infrequent and is less stable over time than is abstinence. An accurate understanding of the long-term course of alcohol use and problems could help shape expectations about the realistic probability of positive outcomes for individuals considering moderate drinking as a treatment goal.

National Dissemination of Motivation Enhancement Therapy in the Veterans Health Administration: Training Program Design and Initial Outcomes.

Motivational enhancement therapy (MET) can be defined most simply as the "….combination of Motivational Interviewing (MI) with assessment feedback…." (Miller & Rollnick, 2013, p. 250). MET has a clear evidence-base promoting its use especially for treatment of substance use disorders (SUDs). Despite its efficacy and utility, MET is not widely used in clinical settings. In 2012, to facilitate the dissemination of MET, the Veterans Health Administration [VHA; the health care component of the U.S. Department of Veterans Affairs (VA)] launched a national training program that provided competency-based training in MET to VA staff working in SUD specialty care clinics. All VA facilities are required to implement EBPs for SUDs, such as MET, and ensure that they are available to veterans. This paper describes the VA MET training program and examines the impact of the MET training program on participants' knowledge of MET and self-reported MET skills. We review the components of the training and consultation and discuss adaptations made from the Project MATCH MET model to a real-world clinical setting. Of the 264 training participants we trained 2012-2013, 213 (81%) successfully completed all requirements of the training program, including requirements for demonstrating competency and attending at least 75% of scheduled consultation calls. After completion of the training program, approximately 85% of the clinicians reported implementing MET often (either 1-3 times per week or daily). Furthermore, we saw significant increases in MI knowledge from pretraining assessment to post-workshop and from pretraining to post-consultations. Additional training program details and revisions are discussed.

Mesa Grande: a methodological analysis of clinical trials of treatments for alcohol use disorders.

AIM: A 3-year update with 59 new controlled trials is provided for the ongoing Mesa Grande project reviewing clinical trials of treatments for alcohol use disorders. The project summarizes the current evidence for various treatment approaches, weighting findings differentially according to the methodological strength of each study. DESIGN: The review includes 361 controlled studies that (1) evaluated at least one treatment for alcohol use disorders, (2) compared it with an alternative condition (such as a control group, a placebo, a brief intervention or an alternative treatment), (3) used a procedure designed to create equivalent groups before treatment and (4) reported at least one outcome measure of drinking or alcohol-related consequences. Studies were rated by two reviewers on 12 methodological criteria, and outcome logic was analyzed for the specific treatment modalities tested. FINDINGS: Methodological quality of studies was significantly but modestly correlated with the reporting of a specific effect of treatment. Among psychosocial treatments, strongest evidence of efficacy was found for brief interventions, social skills training, the community reinforcement approach, behavior contracting, behavioral marital therapy and case management. For the first time, two pharmacotherapies also appeared among the most strongly supported approaches: opiate antagonists (naltrexone, nalmefene) and acamprosate. Least supported were methods designed to educate, confront, shock or foster insight regarding the nature and causes of alcoholism. CONCLUSIONS: Treatment methods differ substantially in apparent efficacy. It would be sensible to consider these differences in designing and funding treatment programs.

How effective is continuing care for substance use disorders? A meta-analytic review.

Given the often chronic nature of substance use disorders, patients sometimes receive less intensive continuing care following an initial period of more intensive treatment. This meta-analysis estimated the effect of continuing care and formally tested several proposed moderators (intervention duration, intensity, modality, and setting) of that effect. A systematic search identified 33 controlled trials of continuing care; 19 included a no/minimal treatment condition and were analyzed to assess the overall effect of continuing care versus control. Continuing care had a small, but significant, positive effect size, both at the end of the continuing care interventions (g=0.187, p<0.001) and at follow-up (g=0.271, p<0.01). Limited by a small number of studies, analyses did not identify any significant moderators of overall effects. These results show that continuing care can provide at least modest benefit after initial treatment. We discuss study characteristics that may have reduced the magnitude of the overall continuing care effect estimate.

Meta-analysis of naltrexone and acamprosate for treating alcohol use disorders: when are these medications most helpful?

AIMS: Although debates over the efficacy of oral naltrexone and acamprosate in treating alcohol use disorders tend to focus on their global efficacy relative to placebo or their efficacy relative to each other, the underlying reality may be more nuanced. This meta-analysis examined when naltrexone and acamprosate are most helpful by testing: (i) the relative efficacy of each medication given its presumed mechanism of action (reducing heavy drinking versus fostering abstinence) and (ii) whether different ways of implementing each medication (required abstinence before treatment, detoxification before treatment, goal of treatment, length of treatment, dosage) moderate its effects. METHODS: A systematic literature search identified 64 randomized, placebo-controlled, English-language clinical trials completed between 1970 and 2009 focused on acamprosate or naltrexone. RESULTS: Acamprosate had a significantly larger effect size than naltrexone on the maintenance of abstinence, and naltrexone had a larger effect size than acamprosate on the reduction of heavy drinking and craving. For naltrexone, requiring abstinence before the trial was associated with larger effect sizes for abstinence maintenance and reduced heavy drinking compared with placebo. For acamprosate, detoxification before medication administration was associated with better abstinence outcomes compared with placebo. CONCLUSIONS: In treatment for alcohol use disorders, acamprosate has been found to be slightly more efficacious in promoting abstinence and naltrexone slightly more efficacious in reducing heavy drinking and craving. Detoxification before treatment or a longer period of required abstinence before treatment is associated with larger medication effects for acamprosate and naltrexone respectively.

Motivational interview improves treatment entry in homeless veterans.

Motivational Interviewing (MI) has successfully been used to facilitate entry and compliance in drug and alcohol treatment programs. Some questions have been raised as to the effectiveness of MI in severely distressed populations. This study aims to assess the effectiveness of MI in a population of homeless, unemployed, and substance dependent veterans who are being wait-listed for entry into a residential treatment program. Seventy-five veterans placed on a wait-list were randomized to receive a single MI or standard (Std) intake interview. Outcomes assessed were entry, and length of stay (LOS). Secondary outcomes assessed included program completion and rates of graduation. Readiness to change and self-efficacy were assessed before and after the interview. Significantly more participants entered the program in the MI group (95%) than in the Std group (71%). Although those in the MI group remained in the program longer, and had higher program completion and graduation rates, these differences were not statistically significant. No significant between-group or within-group differences were found in readiness or self-efficacy. This study demonstrates that a single, easily administered intervention can increase program entry. Also based on the study findings, further research into the question of whether MI can increase program retention, in a severely distressed population, is warranted.

Quantum change: ten years later.

Ten years ago, 55 people shared their stories of personality transformation and sudden extensive cognitive and behavior changes. We termed this type of change "quantum change" (QC). The majority reported that because of their experience, their lives were much better, and most were confident the changes would last. Thirty people from the original study were re-interviewed. Most remembered quite vividly the QC experience reported 10 years earlier. The QC experiences fell along a continuum, with some describing their QC as a one-time event that dramatically changed the way they lived, others experienced repeated changes that were either of similar intensity to the initial experience or milder than the initial experience, and some framed the initial change experience as one aspect of a continuing growth process. These dramatic changes have continued, and none described a return to old ways of being.