Double‐Blind Placebo‐Controlled Trial of Galantamine for Methadone‐Maintained Individuals With Cocaine Use Disorder: Secondary Analysis of Effects on Illicit Opioid Use

• Published in: The American journal on addictions 2019-07, Vol.28 (4), p.238-245
• Main Authors: Carroll, Kathleen M., DeVito, Elise E., Yip, Sarah W., Nich, Charla, Sofuoglu, Mehmet
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Analgesics, Opioid - therapeutic use; Cholinesterase Inhibitors - therapeutic use; Cocaine-Related Disorders - drug therapy; Cocaine-Related Disorders - epidemiology; Double-Blind Method; Female; Follow-Up Studies; Galantamine - therapeutic use; Humans; Male; Methadone - therapeutic use; Middle Aged; Opiate Substitution Treatment - methods; Opioid-Related Disorders - diagnosis; Opioid-Related Disorders - drug therapy; Treatment Outcome; Young Adult
• ISSN: 1055-0496; 1521-0391
• DOI: 10.1111/ajad.12904

Background and Objectives Concurrent use of cocaine and opioids is a persistent and challenging problem, particularly within methadone maintenance settings, and there are no approved pharmacotherapies for this population. Galantamine, a cholinesterase inhibitor, was found in a randomized clinical trial to reduce cocaine use among methadone‐maintained individuals who were also cocaine dependent. Because of the potential of galantamine to reduce multiple drugs of abuse, it may also reduce opioid use. Methods We conducted a secondary analysis of a randomized, double‐blind, placebo‐controlled trial of 120 methadone‐maintained individuals with concurrent cocaine dependence. Participants were randomized to galantamine or placebo in a 12‐week trial with a 6‐month follow‐up (97% of intention to treat sample reached for final follow‐up). Results There was a significant main effect for galantamine over placebo on percent of urine specimens that were negative for opioids, both within treatment (77% for galantamine vs 62% for placebo, F = 5.0, P = 0.027) and through a 6‐month follow‐up (81% vs 59%, respectively, F = 10.8, P = 0.001). This effect was seen regardless of whether participants used nonprescribed opioids during the baseline period. Galantamine effects were seen early in treatment, with participants in placebo submitting the first opioid‐positive urine specimen significantly sooner than participants in galantamine (median day 15 vs 53, Wilcoxon = 5.7, P = 0.02). Conclusions and Scientific Significance If these results are supported in future trials, galantamine may hold promise across multiple drugs of abuse, including opioids. (Am J Addict 2019;28:238–245)