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

Am J Addict. 2019 Jul;28(4):238-245. doi: 10.1111/ajad.12904. Epub 2019 Jun 4.

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).

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • 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

Substances

  • Analgesics, Opioid
  • Cholinesterase Inhibitors
  • Galantamine
  • Methadone