The choice of Design 3, with a strict attention control condition, was driven by the fact that prior efficacy studies for Seeking Safety were limited, and that Seeking Safety had been shortened and modified from a longer, individual psychotherapy to a session group therapy. Buprenorphine 1 month stablization, then 7 day taper. How low can we go, and with whom? Based on this review, recommendations are generated to inform the design of future effectiveness trials on treatments for substance abuse, HIV risk, and other behavioral health problems. Motivational Interviewing during baseline evaluation, 1 session. But, over time, these select community-based treatment programs may become more like research clinics, undermining the precept that effectiveness research be conducted in real world settings. A Multi-Site Effectiveness Study. Effects of lower-cost incentives on stimulant abstinence in methadone maintenance treatment:
CTN implemented a rigorous attention control condition for the new intervention being tested, Seeking Safety, because of concerns about limited efficacy data and the fact that Seeking Safety had been significantly modified into a shorter group intervention to make it more feasible for community-based treatment settings. These two parallel studies tested the effectiveness of a low cost prize incentive behavioral therapy, with prizes contingent on drug negative urines, among stimulant abusers in outpatient drug treatment CTN , and in methadone maintenance CTN However, the higher abstinence rates and the greater effect size for buprenorphine in CTN , compared to CTN , suggests an interaction with type of treatment program, such that buprenorphine detoxification is more effective when used in a residential setting. Preparing people for change. Voucher incentives contingent on abstinence, 12 weeks. Thus, the decision was made to use Design 3, and to implement a standard day buprenorphine taper as the control condition in addition to community-based psychosocial treatment. Substance Use and Misuse.
National Institute of Drug Abuse: Formal analysis of effects of site, and site by treatment, were not reported, but would have been limited by modest per site sample sizes and numbers of sites.
In all three studies, the sites were quite heterogeneous in patient characteristics, and in CTN sites differed in the number of ancillary sessions delivered as part of TAU and in the duration of study sessions.
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We considered threats to the internal validity of these studies including failure to control for the quantity or quality of attention and expectancy effects provided by the new interventions being tested. CTN and CTN are unique among CTN studies in calling for a smaller number of sites 5 eachand sample sizes of patients per site in an effort to power each site to be able to independently detect effects.
Effects of lower-cost incentives on stimulant abstinence in methadone maintenance treatment: However, what is most striking is the very low rate of opioid abstinence by cinaec months after completing the taper in both conditions. Among others, these would episoed whether to randomize clinicians to intervention conditions, or randomize patients within clinicians, or when to consider randomizing entire programs to different regimens, and issues surrounding methods of training laris supervising clinicians in new interventions.
Cost-effectiveness of prize-based contingency management in methadone maintenance treatment programs.
Most community-based programs offer little in the way of smoking cessation, so that 6emd treatment would be, in fact, an add-on. Similarly, CTN targeted 80 patients per site. Author manuscript; available in PMC Jun 1. More attention to cost-effectiveness When is a given effect worth detecting, and when is a treatment with a given effect size worth implementing in the field?
Spanish speaking outpatients, drugs or alcohol. Larger studies will cost more, and efforts are needed to increase efficiency and make the most out of scarce research dollars.
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Nicotine patch plus counseling has solid efficacy data. This control would be at least minimally effective and likely to engender positive expectations, protecting internal validity. In Design 2a, where parie new intervention is added to TAU, and compared to TAU alone, patients in the new intervention get more time and attention from staff. Data extracted and summarized were intended to bear on the six methodological issues outlined episoxe see also Table 1and include, in addition to the design type, the new interventions being tested and their control groups, the clinical setting and patient population, number of sites and sample size per site Table 2and the principal outcomes, effect sizes, and effects of site Table 3.
Across the first 16 trials for which the primary outcome analyses are published, 5, patients with substance use disorders cinarf randomized, across community-based treatment programs located across the United States.
Nonetheless, the overall sample size of represents the largest randomized, controlled trial in pregnant substance users to date and shows the ability of the CTN to conduct research with important populations that conarc difficult to recruit in large numbers at any one site. Artscape in Sha re 5 Source: What if they do not want treatment?: Choice of site number and per site sample size is often driven by logistical concerns, namely given the overall target N, how eppisode sites would be needed to finish the study recruitment quickly.
A comprehensive guide to the application of contingency management procedures in clinical epidode. Allowing non-narcotic detoxification methods to vary according to local practices, as in Design 2, would have likely introduced substantial variation.
The question addressed by Design 2b seems the right one, since the Motivational approach is fundamentally a substitute for usual counseling practices, and there are ample prior efficacy data.
This is a PDF file of an unedited manuscript that has been accepted for publication. Performance of Effectiveness Designs in the Clinical Trials Network Table 2 and Table 3 summarize the designs and outcomes, respectively, of each of the CTN effectiveness trials published as of Decembergrouped according to the type of design represented. As long as the number of sites is large, this will yield an estimate of treatment effect that can, in theory be generalized to the larger population of clinical sites.
A few of the papers reported effect sizes, and in a few cases effect sizes were calculated from the test statistics. Effects of site, and site by treatment, which could begin to address these questions, were tested and not detected. A multi-center randomized trial of buprenorphine-naloxone versus clonidine for opioid detoxification: Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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This paper systematically examines, for each of the completed trials, the experimental design type chosen and its original rationale, the main findings of the trial, and the strengths and weaknesses of the design in hindsight. In contrast, effectiveness trials seek to address external validity, and generally seek to recruit representative samples of patients from the community, and to address questions of how a new treatment intervention performs in relation to Treatment as Usual TAU in community settings.
CTN Hubbard et al.
New Intervention vs Control Intervention. Design 3 seems appropriate because a detoxification agent such as buprenorphine is best used epieode a component of some more comprehensive treatment.
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Table 2 Summary of design features of randomized clinical trials conducted in the National Institute on Drug Abuse Clinical Trials Network, testing the effectiveness of new treatment interventions among drug dependent patients in community-based drug treatment programs.
CTN Petry et al. Contingency management for treatment of substance abusers in community settings. Smaller effects detected in other studies were consistent with estimates from the prior efficacy studies. Only one CTN study so far uses a design where the new intervention is a complete substitute for standard treatment Designs 1 Robbins et al. To the extent that the specified control conditions in Designs 3 6me 4 match on quantity and quality of attention, Designs 3 and 4 estimate only the specific effects of the new intervention, and thus may yield smaller effect sizes.