Background: We recently showed in a placebo-controlled trial (n=11) that oxytocin (OXY) (24 IU insufflation bid) demonstrated efficacy in reducing withdrawal symptoms, anxiety and need for lorazepam in subjects with alcohol dependence undergoing detoxification (Pedersen et al, ACER 37:484, 2013).
Methods: The current pilot study tested for safety and efficacy of OXY compared to placebo (PBO) in subjects admitted to a residential community detoxification center. Effects on withdrawal and on subsequent drinking behavior, craving and anxiety were examined. Subjects with alcohol dependence and a history of withdrawal were enrolled within 48 hours of admission and received 4 insufflations of OXY (24 IU per dose) or PBO on Day 1, 3 doses on subsequent inpatient days and then bid dosing on outpatient days. Subjects were also recruited post-detox for the drinking trial and received similar dosing except no qid dosing on Day 1. Subjects were followed for 12 weeks as outpatients and received Medical Management.
Results: 115 subjects were prescreened to give 30 subjects fully screened to yield 19 randomized subjects. 8 subjects (4 OXY) form the detox inpatient group with the outpatient group consisting of 9 subjects (6 OXY) who completed at least 4 weeks of medication. Subjects receiving OXY during detox had a mean reduction in CIWA of 2.8 in the 48 hrs post-randomization vs an increase of 1.0 on PBO (p=.025) and used a mean of 2.25 mg lorazepam vs 5.25 mg lorazepam with PBO (p=.076). During the outpatient phase both the OXY and PBO groups had large reductions in heavy drinking days and large increases in abstinent days with decreased craving and anxiety but no significant OXY/PBO differences were found. No serious adverse events were seen, 2 OXY subjects complained of nose irritation and 2 subjects stopped meds (1 PBO for hives and 1 OXY for burning in the nose).
Conclusions: The finding of a significant reduction in alcohol withdrawal symptoms with less lorazepam use in the OXY vs PBO condition is compatible with our initial trial and is of therapeutic interest given that OXY does not have the deleterious profile of sedation and addiction liability associated with the benzodiazepines. The failure to find an OXY vs PBO effect on drinking behavior, anxiety or craving post-detox is difficult to interpret given the limited power of the trial. Tolerability of OXY was reasonable. Additional OXY trials in alcohol dependence are warranted.