Contemporary clinical trials
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Contemp Clin Trials · Sep 2016
Clinical TrialDesign of the NIDA clinical trials network validation study of tobacco, alcohol, prescription medications, and substance use/misuse (TAPS) tool.
Substance use and its associated use disorders are under-detected and under-treated in primary care. There is a need for a clinically useful brief screening and assessment instrument to identify primary care patients with substance use, sub-threshold substance use disorder (SUD), and SUD to facilitate brief intervention and treatment. ⋯ The TAPS Tool study builds on prior work to develop a 2-stage clinical tool for facilitating the adoption of screening, brief assessment and treatment for SUDs in primary care.
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Contemp Clin Trials · Sep 2016
Randomized Controlled Trial Multicenter StudyNIDA Clinical Trials Network CTN-0051, Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment (X:BOT): Study design and rationale.
For opioid-dependent patients in the US and elsewhere, detoxification and counseling-only aftercare are treatment mainstays. Long-term abstinence is rarely achieved; many patients relapse and overdose after detoxification. Methadone, buprenorphine-naloxone (BUP-NX) and extended-release naltrexone (XR-NTX) can prevent opioid relapse but are underutilized. This study is intended to develop an evidence-base to help patients and providers make informed choices and to foster wider adoption of relapse-prevention pharmacotherapies. ⋯ NCT02032433.
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Contemp Clin Trials · Sep 2016
Randomized Controlled TrialQigong/Tai Chi Easy for fatigue in breast cancer survivors: Rationale and design of a randomized clinical trial.
Breast cancer survivors (BCSs) often report fatigue that persists for years following treatment. Despite a growing body of evidence for meditative movement practices to improve symptoms among BCSs, few studies have explored using Qigong/Tai Chi to reduce fatigue. Additionally, few have examined the biological mechanisms through which fatigue may be reduced using Qigong/Tai Chi. ⋯ Findings from this study may reveal the effects of the unique mind-body aspects of QG/TCE on fatigue in BCSs with a complex design that separates the effects of low-intensity physical activity (SQG) and social support/attention (ES) from the primary intervention. Further, results will likely contribute greater understanding of the biological mechanisms of these practices related to improved symptoms among BCSs.
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Contemp Clin Trials · Sep 2016
Randomized Controlled TrialStudy design, interventions, and baseline characteristics for the Substance use and TRauma Intervention for VEterans (STRIVE) trial.
While comorbidity between posttraumatic stress disorder (PTSD) and substance use disorders (SUD) is common among veterans, there is debate regarding how to best treat individuals suffering from both conditions. Despite data supporting the effectiveness of integrated treatments that simultaneously address both disorders, due to concerns that an early focus on trauma may increase dropout and reduce the likelihood of achieving SUD-related goals, providers continue to prefer a sequential approach, where the addiction is treated first and PTSD treatment is instituted following sustained abstinence or reduced use. This project is designed to directly examine these provider concerns by evaluating the benefits and harms of an integrated versus a sequential approach to treating comorbid PTSD and SUD. ⋯ In this randomized clinical trial, one hundred eighty-three veterans with co-occurring PTSD and SUD have been randomized to one of two psychotherapies that include the same treatment components for SUD and PTSD (Motivational Enhancement Therapy and Prolonged Exposure respectively), but differ by whether the components are delivered sequentially or are integrated such that PTSD and SUD symptoms are addressed concurrently. We hypothesize that veterans assigned to integrated treatment will show greater improvement in PTSD and SUD symptoms than veterans assigned to sequential treatment. If this hypothesis is supported, the findings have the potential to change clinicians' beliefs and challenge long-standing practice patterns that require participation in SUD treatment prior to initiating trauma-focused therapies for PTSD.
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Contemp Clin Trials · Jul 2016
Randomized Controlled TrialExtended-release naltrexone opioid treatment at jail reentry (XOR).
Extended-release naltrexone (XR-NTX) is an injectable monthly sustained-release mu opioid receptor antagonist, which blocks the typical effects of heroin and other opioid agonists. Use of XR-NTX among opioid dependent persons leaving jails and prisons is increasing despite scant high-quality evidence regarding XR-NTX's effectiveness at re-entry. ⋯ XR-NTX is a potentially important, effective treatment and relapse prevention option for a large US population of persons with opioid use disorders leaving jails. This study will estimate XR-NTX's effectiveness relative to existing standards of care, including counseling-only treatment-as-usual and methadone maintenance.