%0 Journal Article %J J Subst Abuse Treat %D 2012 %T Mindful awareness in body-oriented therapy as an adjunct to women's substance use disorder treatment: a pilot feasibility study. %A Price, Cynthia J %A Wells, Elizabeth A %A Donovan, Dennis M %A Rue, Tessa %K Adult %K Anxiety %K Cognitive Therapy %K Depression %K Feasibility Studies %K Feeding and Eating Disorders %K Female %K Follow-Up Studies %K Humans %K Middle Aged %K Mind-Body Therapies %K Pilot Projects %K Recurrence %K Stress, Psychological %K Substance-Related Disorders %K Treatment Outcome %K Young Adult %X

This study examined mindful awareness in body-oriented therapy (MABT) feasibility as a novel adjunct to women's substance use disorder (SUD) treatment. As an individual therapy, MABT combines manual and mind-body approaches to develop interoception and self-care tools for emotion regulation. A 2-group randomized controlled trial repeated-measures design was used, comparing MABT to treatment as usual (TAU) on relapse to substance use and related health outcomes. Sixty-one women were screened for eligibility, and 46 enrolled. Participants randomized to MABT received 8 weekly MABT sessions. Results showed moderate to large effects, including significantly fewer days on substance use, the primary outcome, for MABT compared with TAU at posttest. Secondary outcomes showed improved eating disorder symptoms, depression, anxiety, dissociation, perceived stress, physical symptom frequency, and bodily dissociation for MABT compared with TAU at the 9-month follow-up. In conclusion, it is feasible to implement MABT in women's SUD treatment, and results suggest that MABT is worthy of further efficacy testing.

%B J Subst Abuse Treat %V 43 %P 94-107 %8 2012 Jul %G eng %N 1 %R 10.1016/j.jsat.2011.09.016 %0 Journal Article %J Addiction %D 2012 %T Primary outcome indices in illicit drug dependence treatment research: systematic approach to selection and measurement of drug use end-points in clinical trials. %A Donovan, Dennis M %A Bigelow, George E %A Brigham, Gregory S %A Carroll, Kathleen M %A Cohen, Allan J %A Gardin, John G %A Hamilton, John A %A Huestis, Marilyn A %A Hughes, John R %A Lindblad, Robert %A Marlatt, G Alan %A Preston, Kenzie L %A Selzer, Jeffrey A %A Somoza, Eugene C %A Wakim, Paul G %A Wells, Elizabeth A %K Alcoholism %K Biomedical Research %K Clinical Trials as Topic %K Consensus %K Endpoint Determination %K Humans %K Self Report %K Street Drugs %K Substance Abuse Detection %K Substance Withdrawal Syndrome %K Substance-Related Disorders %K Tobacco Use Disorder %K Treatment Outcome %X

AIMS: Clinical trials test the safety and efficacy of behavioral and pharmacological interventions in drug-dependent individuals. However, there is no consensus about the most appropriate outcome(s) to consider in determining treatment efficacy or on the most appropriate methods for assessing selected outcome(s). We summarize the discussion and recommendations of treatment and research experts, convened by the US National Institute on Drug Abuse, to select appropriate primary outcomes for drug dependence treatment clinical trials, and in particular the feasibility of selecting a common outcome to be included in all or most trials.

METHODS: A brief history of outcomes employed in prior drug dependence treatment research, incorporating perspectives from tobacco and alcohol research, is included. The relative merits and limitations of focusing on drug-taking behavior, as measured by self-report and qualitative or quantitative biological markers, are evaluated.

RESULTS: Drug-taking behavior, measured ideally by a combination of self-report and biological indicators, is seen as the most appropriate proximal primary outcome in drug dependence treatment clinical trials.

CONCLUSIONS: We conclude that the most appropriate outcome will vary as a function of salient variables inherent in the clinical trial, such as the type of intervention, its target, treatment goals (e.g. abstinence or reduction of use) and the perspective being taken (e.g. researcher, clinical program, patient, society). It is recommended that a decision process, based on such trial variables, be developed to guide the selection of primary and secondary outcomes as well as the methods to assess them.

%B Addiction %V 107 %P 694-708 %8 2012 Apr %G eng %N 4 %R 10.1111/j.1360-0443.2011.03473.x %0 Journal Article %J J Subst Abuse Treat %D 2010 %T Study results from the Clinical Trials Network's first 10 years: where do they lead? %A Wells, Elizabeth A %A Saxon, Andrew J %A Calsyn, Donald A %A Jackson, Thomas R %A Donovan, Dennis M %K Clinical Trials as Topic %K Humans %K National Institute on Drug Abuse (U.S.) %K Quality Assurance, Health Care %K Research Design %K Risk-Taking %K Substance-Related Disorders %K Treatment Outcome %K United States %X

The National Drug Abuse Treatment Clinical Trials Network (CTN) began in 2000 with the goal of "improv[ing] the quality of drug abuse treatment throughout the country using science as the vehicle." Since then, 24 discrete clinical trials were launched, 20 are completed, and 15 have published main outcome papers. Of the latter, 4 tested pharmacological treatment, 8 psychosocial/behavioral treatment, 1 a combination of medication and counseling, and 2 targeted HIV/hepatitis C virus risk behavior. We review main study findings for these trials, including treatment retention, substance use or risk behavior outcomes, and secondary outcomes when analyzed. The purpose of this review is to identify the incremental progress toward improving drug treatment made by these trials and to propose next steps for the CTN and for the field arising from these studies. The CTN provides a unique opportunity to systematically design trials that incorporate treatment improvements from previous trials and to direct efforts toward innovations most likely to be incorporated into practice.

%B J Subst Abuse Treat %V 38 Suppl 1 %P S14-30 %8 2010 Jun %G eng %R 10.1016/j.jsat.2009.12.009