ABSTRACT
Background: Oxytocin (OT) treatment in drug addiction studies have suggested potential therapeutic benefits. There is a paucity of clinical trial studies of oxytocin in cocaine use disorders. Method: This was a 6-week randomized, double-blind, outpatient clinical trial study investigating the effect of daily Intranasal Oxytocin (24 IU) on cocaine use by cocaine use disorder patients. After a 7-day inpatient abstinence induction stage, patients were randomized to intranasal oxytocin or intranasal placebo. During the outpatient phase, cocaine use disorder patients were required to present themselves to the research staff 3 times a week for witnessed randomized medication administration, to provide a urine sample for qualitative toxicology, and complete mandatory assessments, including the Time-Line-Follow Back. For the interim days, patients were given an "at-home" bottle that was weighed at each clinic visit to monitor compliance. Results: Neither administration of Intranasal placebo (n = 11) or Oxytocin (n = 15) induced at least 3 weeks of continuous abstinence. However, from week 3, the odds of weekly abstinence increased from 4.61 (95% CI = 1.05, 20.3) to 15.0 (CI = 1.18, 190.2) by week 6 for the Intranasal Oxytocin group (t = 2.12, p = 0.037), though there was no significant group difference overall in the odds of abstinence over time (F1,69 = 1.73, p = 0.19). More patients on Intranasal Oxytocin dropped out (p = 0.0005). Conclusions: Intranasal Oxytocin increased the odds of weekly abstinence in Cocaine patients after 2 weeks compared to PBO, but was associated with a higher dropout rate. (ClinicalTrials.gov 02,255,357, 10/2014).
