At a glance
ClinicalIndex Comparison Record- ✓Meet DSM-5 criteria for severe alcohol use disorder AND DSM-IV criteria for alcohol dependence within the last 12 months
- ✓Currently abstinent from alcohol (BAC 0.00 by breathalyser) and negative urine drug screening
- ✓Minimum of mild depression (Beck Depression Inventory-II >14)
- ✓Capacity to give informed consent per GCP guidelines
- ✕Currently taking relapse prevention medication or anti-depressants
- ✕Uncontrolled hypertension (systolic ≥140 mmHg or diastolic ≥90 mmHg)
- ✕BMI <16 or >35
- ✕History of psychosis or first-degree relative with psychosis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II, Randomised, Double-blind, Placebo- Controlled, Multi-site, Parallel Group Clinical Trial to Examine Ketamine as a Pharmacological Treatment for Alcohol Dependence in an Alcohol Dependent Population
In Brief
A Phase 2 clinical trial evaluating Ketamine, Placebo, and 2 other interventions for Primary Alcohol Use Disorder. Completed, enrolled 96 participants across 2 sites.
Detailed Summary
96 recently detoxified alcoholics will be randomized to receive either 3 sessions ketamine (0.8 mg/kg IV over 45 minutes) or placebo plus manualised psychological therapy, or 3 sessions of ketamine or placebo plus simple psychoeducation. Patients will be assessed at 3 and 6 months on a range of psychological and biological variables. Primary endpoints will be % days abstinent at 6 months and relapse rates at 6 months. Secondary endpoints include depressive symptoms, craving, quality of life.
Study Details
Timeline
Interventions
0.8 mg/kg ketamine
0.9% saline
Manualised relapse prevention based CBT
Simple education about alcohol effects