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A Phase Iii, Randomized, Multi-Center, Double Blind, Placebo Controlled Study Of Safety And Efficacy Of Lofexidine For Relief Of Symptoms In Individuals Undergoing Inpatient Opioid Withdrawal, Charles W. Gorodetzky, Sharon L. Walsh, Peter R. Martin, Andrew J. Saxon, Kristen L. Gullo, Kousick Biswas
A Phase Iii, Randomized, Multi-Center, Double Blind, Placebo Controlled Study Of Safety And Efficacy Of Lofexidine For Relief Of Symptoms In Individuals Undergoing Inpatient Opioid Withdrawal, Charles W. Gorodetzky, Sharon L. Walsh, Peter R. Martin, Andrew J. Saxon, Kristen L. Gullo, Kousick Biswas
Center on Drug and Alcohol Research Faculty Publications
Background: Lofexidine is an alpha-2-adrenergic receptor agonist approved in the United Kingdom (UK) for the treatment of opioid withdrawal symptoms. Lofexidine has demonstrated better efficacy than placebo for reducing opioid withdrawal symptoms in patients undergoing opioid withdrawal with less reported hypotension than clonidine.
Methods: Designed as an FDA registration trial, this 8-day, randomized, double-blind, placebo-controlled, parallel-group study in 264 patients dependent on short-acting opioids evaluated the efficacy of lofexidine hydrochloride in reducing withdrawal symptoms in patients undergoing opioid withdrawal. The primary efficacy measures were SOWS-Gossop on Day 3 and time-to-dropout. Secondary endpoints included the proportion of participants who were completers; …
Comparing Adult Cannabis Treatment-Seekers Enrolled In A Clinical Trial With National Samples Of Cannabis Users In The United States, Erin A. Mcclure, Jacqueline S. King, Aimee Wahle, Abigail G. Matthews, Susan C. Sonne, Michelle R. Lofwall, Aimee L. Mcrae-Clark, Udi E. Ghitza, Melissa Martinez, Kasie Cloud, Harvir S. Virk, Kevin M. Gray
Comparing Adult Cannabis Treatment-Seekers Enrolled In A Clinical Trial With National Samples Of Cannabis Users In The United States, Erin A. Mcclure, Jacqueline S. King, Aimee Wahle, Abigail G. Matthews, Susan C. Sonne, Michelle R. Lofwall, Aimee L. Mcrae-Clark, Udi E. Ghitza, Melissa Martinez, Kasie Cloud, Harvir S. Virk, Kevin M. Gray
Center on Drug and Alcohol Research Faculty Publications
Background—Cannabis use rates are increasing among adults in the United States (US) while the perception of harm is declining. This may result in an increased prevalence of cannabis use disorder and the need for more clinical trials to evaluate efficacious treatment strategies. Clinical trials are the gold standard for evaluating treatment, yet study samples are rarely representative of the target population. This finding has not yet been established for cannabis treatment trials. This study compared demographic and cannabis use characteristics of a cannabis cessation clinical trial sample (run through National Drug Abuse Treatment Clinical Trials Network) with three nationally …