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

Abstract

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).

• Authors: Kathleen M Carroll, Elise E DeVito, Sarah W Yip, Charla Nich, Mehmet Sofuoglu
• Journal: The American journal on addictions (Am J Addict) Vol. 28 Issue 4 Pg. 238-245 (07 2019) ISSN: 1521-0391 [Electronic] England
• PMID: 31165574 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural)
• Copyright: © 2019 American Academy of Addiction Psychiatry.

Chemical References

• Analgesics, Opioid
• Cholinesterase Inhibitors
• Galantamine
• Methadone

Topics

• Adolescent
• Adult
• Aged
• Analgesics, Opioid (therapeutic use)
• Cholinesterase Inhibitors (therapeutic use)
• Cocaine-Related Disorders (drug therapy, 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, drug therapy)
• Treatment Outcome
• Young Adult