NCT02649231

Ketamine for Reduction of Alcoholic Relapse

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Alcohol Use Disorder

Interventions

Type	Name	Description
DRUG	Ketamine	0.8 mg/kg ketamine
DRUG	Placebo	0.9% saline
BEHAVIORAL	Psychological Therapy	Manualised relapse prevention based CBT
BEHAVIORAL	Alcohol Education	Simple education about alcohol effects

Timeline

• Start date: 2016-10-01
• Primary completion: 2020-02-01
• Completion: 2020-02-01
• First posted: 2016-01-07
• Last updated: 2021-10-05
• Results posted: 2021-09-09

Locations

2 sites across 1 country: United Kingdom