NCT02649231

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2016

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

September 9, 2021

Completed
Last Updated

October 5, 2021

Status Verified

September 1, 2021

Enrollment Period

3.3 years

First QC Date

January 5, 2016

Results QC Date

August 5, 2021

Last Update Submit

September 9, 2021

Conditions

Primary Alcohol Use Disorder

Outcome Measures

Primary Outcomes (2)

  • Relapse Rates

    Time line follow back

    6 months

  • Percentage Days Abstinent

    Time line follow back

    6 months

Study Arms (4)

Ketamine+Psychological Therapy

EXPERIMENTAL

Ketamine with psychological therapy

Drug: KetamineBehavioral: Psychological Therapy

Ketamine+Education

ACTIVE COMPARATOR

ketamine with alcohol education

Drug: KetamineBehavioral: Alcohol Education

Placebo+Psychological Therapy

ACTIVE COMPARATOR

placebo with psychological therapy

Drug: PlaceboBehavioral: Psychological Therapy

Placebo+Education

PLACEBO COMPARATOR

placebo with simple alcohol education

Drug: PlaceboBehavioral: Alcohol Education

Interventions

KetamineDRUG

0.8 mg/kg ketamine

Ketamine+EducationKetamine+Psychological Therapy
PlaceboDRUG

0.9% saline

Placebo+EducationPlacebo+Psychological Therapy
Psychological TherapyBEHAVIORAL

Manualised relapse prevention based CBT

Ketamine+Psychological TherapyPlacebo+Psychological Therapy
Alcohol EducationBEHAVIORAL

Simple education about alcohol effects

Ketamine+EducationPlacebo+Education

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Meet either a) DSM-5 criteria for severe alcohol use disorder and b) DSM-IV criteria for alcohol dependence within the last 12 months;
  • Currently abstinent from alcohol (breathalyser BAC level 0.00) and negative urine drug screening (participants testing positive for THC who do not have a history or current cannabis dependency may be included);
  • Minimum of mild depression(\>14 on Beck Depression Inventory-II);
  • Capacity to give informed consent as defined by GCP guidelines;
  • Willing and able to wear SCRAM-X bracelet for 6 months;
  • Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; True abstinence) from the time consent is signed until 6 weeks after treatment discontinuation and inform the trial if pregnancy occurs. For the purpose of clarity, True abstinence is when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence, withdrawal, spermicides only or lactational amenorrhoea method for the duration of a trial, are not acceptable methods of contraception;
  • Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for trial treatment and on day of first treatment.

You may not qualify if:

  • Currently taking any other relapse prevention medication or anti-depressants;
  • Uncontrolled hypertension, systolic 140mm Hg or greater and diastolic 90mm Hg or greater;
  • \<16 or \> 35 BMI
  • History of psychosis, or in a first-degree relative as identified by DSM-5 or DSM-IV SCID; co-morbid current psychiatric diagnosis excluding depression, identified via self-reported or identified by a medical professional;
  • Previous or current diagnosis of substance dependence / severe substance misuse disorder;
  • History of neuropsychological difficulties
  • One or more previous confirmed seizures;
  • Currently taking daily prescribed medication contraindicated in the SPC with ketamine:
  • Barbiturates and/or narcotics
  • Atracurium and tubocurarine
  • Central nervous system (CNS) depressants (e.g. phenothiazines, sedating H1 - blockers or skeletal muscle relaxants)
  • Anxiolytics, sedatives and hypnotics
  • Thiopental, thyroid hormones
  • Antihypertensive agents
  • Theophylline and methylxanthines.
  • +22 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

NIHR Exeter Clinical Research Facility

Exeter, EX4 5DW, United Kingdom

Location

NIHR UCLH Clinical Research Facility

London, NW1 2BU, United Kingdom

Location

Related Publications (3)

  • Grabski M, McAndrew A, Lawn W, Marsh B, Raymen L, Stevens T, Hardy L, Warren F, Bloomfield M, Borissova A, Maschauer E, Broomby R, Price R, Coathup R, Gilhooly D, Palmer E, Gordon-Williams R, Hill R, Harris J, Mollaahmetoglu OM, Curran HV, Brandner B, Lingford-Hughes A, Morgan CJA. Adjunctive Ketamine With Relapse Prevention-Based Psychological Therapy in the Treatment of Alcohol Use Disorder. Am J Psychiatry. 2022 Feb;179(2):152-162. doi: 10.1176/appi.ajp.2021.21030277. Epub 2022 Jan 11.

    PMID: 35012326DERIVED

  • Grabski M, Borissova A, Marsh B, Morgan CJA, Curran HV. Ketamine as a mental health treatment: Are acute psychoactive effects associated with outcomes? A systematic review. Behav Brain Res. 2020 Aug 17;392:112629. doi: 10.1016/j.bbr.2020.112629. Epub 2020 May 30.

    PMID: 32485203DERIVED

  • McAndrew A, Lawn W, Stevens T, Porffy L, Brandner B, Morgan CJ. A proof-of-concept investigation into ketamine as a pharmacological treatment for alcohol dependence: study protocol for a randomised controlled trial. Trials. 2017 Apr 4;18(1):159. doi: 10.1186/s13063-017-1895-6.

    PMID: 28372596DERIVED

MeSH Terms

Interventions

KetamineEthanol

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsAlcohols

Results Point of Contact

Title
Professor Celia Morgan
Organization
University of Exeter
Celia.Morgan@exeter.ac.uk
01392 724649

Study Officials

  • Celia Morgan, Ph.D.

    UCL

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2016

First Posted

January 7, 2016

Study Start

October 1, 2016

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

October 5, 2021

Results First Posted

September 9, 2021

Record last verified: 2021-09

Locations

GB(2)