This randomised controlled trial (n=24) investigates the rapid alleviation of depression in individuals with coexisting alcohol dependence (AUD), utilising ketamine at sub-anaesthetic doses (7-140mg/70kg intramuscular).
The study, registered on ANZCTR with the identifier ACTRN12610000390088, aims to characterise the best use of ketamine for rapid antidepressant treatment in depressed alcoholics. Participants will receive four separate infusions of blinded ketamine or saline placebo, with each administration separated by approximately seven days.
The primary outcomes include assessing the proportion of subjects showing remission (Montgomery-Asberg Depression Rating Scale <7) and the reduction in alcohol consumption.
The study is conducted at the University of Otago in New Zealand and is funded by the University of Otago Research Grant. Ethical approval is pending as of the last available update in June 2010, and the anticipated recruitment start date is in September 2010.
Trial Details
The intervention is utilising ketamine at sub-anaesthetic doses. Dose range of ketamine is 0.1 to 2mgs/kg intramuscular (IM). All subjects are scheduled to receive 4 separate infusions of blinded ketamine/saline placebo, with each administration separated by ~7 days. IM doses of ketamine in cohort 1 will be 0.1, 0.25 and 0.5mg/kg. In cohort 2, doses will be 0.5, 1, and 2 mg/kg (note: there is a common dose level between groups). Placebo will be inserted randomly into the dosing sequence. Clinic visits for each subject are the ketamine dose procedure, Follow-up visits at day1, day 3 & day 7 post infusion (a total 4 visits per participant). For each participant there is an ascending dose subject to safety and tolerability of preceding dose. As above the 2nd cohort has a higher dose range.NCT Number ACTRN12610000390088
Sponsors & Collaborators
University of OtagoThe University of Otago (specifically the Dunedin School of Medicine) is associated with psychedelic research but doesn't yet have a full profile.