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Tag Archives: clinical-trials

Comparative Dynamics of Four Smoking Withdrawal Symptom Scales

Abstract Aims: Examine the association of person-specific trajectories of withdrawal symptoms of urge-to-smoke, negative affect, physical symptoms, and hunger during the first 7 days after smoking cessation with abstinence at end of treatment (EOT) and 6 months. Design: Hierarchical Linear Modeling (HLM) was used to model person-specific trajectory parameters (level, slope, curvature and volatility) for withdrawal symptoms. Setting: University-based smoking cessation trials.

Pharmacological interventions in the treatment of the acute effects of Cannabis: a systematic review of literature

Background: Cannabis intoxication is related to a number of physical and mental health risks with ensuing social costs. However, little attention has been given to the investigation of possible pharmacological interactions in this condition. Objective: To review the available scientific literature concerning pharmacological interventions for the treatment of the acute effects of cannabis

Gender research in the national institute on drug abuse national treatment clinical trials network: a summary of findings.

Conclusions: These published studies have expanded the evidence base regarding interventions for vulnerable groups of women with SUDs as well as gender-specific interventions to reduce HIV risk behaviors in substance-using men and women. The results also underscore the complexity of accounting for gender in the design of clinical trials and analysis of results. Scientific Significance: To fully understand the relevance of gender-specific moderators and mediators of outcome, it is essential that future translational studies adopt more sophisticated approaches to understanding and measuring gender-relevant factors and plan sample sizes that are adequate to support more nuanced analytic methods

Power of automated algorithms for combining time-line follow-back and urine drug screening test results in stimulant-abuse clinical trials.

Conclusions: Further investigation is needed to determine if simple, naïve procedures such as the ELCON algorithms are optimal for comparing clinical study treatment arms. But researchers who currently require an automated algorithm in scenarios similar to those simulated for combining TLFB and UDS to test group differences in stimulant use should consider one of the ELCON algorithms. Scientific Significance: This analysis continues a line of inquiry which could determine how best to measure outpatient stimulant use in clinical trials (NIDA.

Standardized patient walkthroughs in the national drug abuse treatment clinical trials network: common challenges to protocol implementation.

Conclusions and Scientific Significance: Standardized patient walkthroughs capture issues with study procedures previously unidentified with didactic training or unscripted rehearsals. Clinical trials within the National Drug Abuse Treatment Clinical Trials Network are conducted in addiction treatment centers that vary on multiple dimensions. Based on walkthrough observations, the national protocol team and local site leadership modify standardized operating procedures and resolve cross-site problems prior to recruiting study participants

Strategies for safety reporting in substance abuse trials.

Conclusion: Comparison of the previous reporting strategies used in SUD trials to the new strategy demonstrates a more consistent safety system with a reduction in safety reporting burden while maintaining appropriate safety monitoring. Scientific Significance: Safety assessments should be tailored to the participant risks based on the trial intervention. The current strategies could be applied to safety assessments across all clinical trials in SUDs.

Primary outcome indices in illicit drug dependence treatment research: systematic approach to selection and measurement of drug use end-points in…

ABSTRACT 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)

Relative performance of common biochemical indicators in detecting cigarette smoking

ABSTRACT Aims Many cities have banned indoor smoking in public places. Thus, an updated recommendation for a breath carbon monoxide (CO) cutoff is needed that optimally determines smoking status

UT Southwestern Researchers Lead Network Of Texas Scientists Trying To Find Better Drug-Addiction Treatments

UT Southwestern Medical Center psychiatry researchers are leading the Texas arm of a national network that conducts clinical trials aimed at finding effective treatments for drug addiction. More than 100 community treatment providers and academic medical centers throughout the country are funded in part through the National Institute on Drug Abuse’s Clinical Trials Network (CTN)…

The expansion of the field of research on ayahuasca: Some reflections about the ayahuasca track at the 2010 MAPS “Psychedelic Science in the 21st…

A recent conference sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS) in collaboration with the Heffter Research Institute, the Beckley Foundation and the Council on Spiritual Practices held from April 15th to 18th 2010, in San José, USA () united 90 presenters and 1100 participants with the goal of giving visibility to studies on the therapeutic potentials of psychedelics (psilocybin, MDMA, ibogaine, ayahuasca, etc.) in the treatment of often intractable ailments such as anxiety in terminal cancer patients, cluster headaches, obsessive–compulsive disorders, drug addiction, and post-traumatic stress disorders, as well as the role of these substances in human enhancement and well-being in general. MAPS was chartered in 1986, with the mission to develop cannabis and psychedelics into prescription medicines to treat illnesses, to build a network of clinics where these prescription medicines can be administered, and to provide public education on the harm and benefits of using psychedelics and cannabis.