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Ketamine for Reduction of Alcoholic Relapse

NCT02649231 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2021-10-05

Study results available
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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

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

Sponsors & Collaborators

  • University College, London

    lead OTHER

Principal Investigators

  • Celia Morgan, Ph.D. · UCL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2020-02-29
Completion
2020-02-29

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02649231 on ClinicalTrials.gov