Hazardous and harmful drinking behaviour Mental and Behavioural Disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Scoring >8 on the Alcohol Use Disorders Identification Test (AUDIT) 2. Consuming > 40 (men) or >30 (women) UK units/week 3. Primarily drinking beer 4. Non-treatment seeking 5. Drinking = 4 days/week 6. Drinking >3 units on drinking days 7. Aged 18-60 8. Endorsing a statement of being ‘highly motivated to reduce’ drinking 9. BMI >18<35
Exclusion criteria
Exclusion criteria: 1. Diagnosis of alcohol or substance use disorder (AUD/SUD) or other psychiatric disorder 2. Undergoing or seeking treatment for alcohol use 3. Undergoing or seeking treatment for any psychiatric disorder 4. Use of recreational drugs (other than tobacco) > 1x/ month 5. Major physical health issues contraindicating ketamine 6. Blood pressure > 145/90, allergy/contraindication to ketamine 7. Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured from baseline (pre-manipulation, Day 1) to post manipulation (Day 10): 1. Alcohol reactivity and priming; operationalized as self-rated urge to drink in-vivo alcohol (beer), urge to drink more beer post-consumption and anticipated/actual enjoyment of the beer pre/post consumption. 2. Harmful drinking behavior, operationalized as number of drinking days and heavy drinking or 'binge' days per week and quantitative alcohol consumption, as assessed by the Timeline Follow-Back. 3. Perceived changes in drinking behaviour from Day 1 to Day 10, consisting of 5-point Likert scale items judging relative urge to drink, enjoyment of drinking and volume of drinking (anchored 'much less than usual' to 'much more than usual'). These are rated retrospectively on Day 10. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Maintenance of any post-manipulation changes in drinking behavior (according to the Timeline Follow-Back) at 9 month follow-up 2. Changes in liking and ‘urge to drink’ responses to visual images of beer, wine, soft drink (orange juice) and neutral images from Day 1 to Day 10. All ratings are on an 11-point scale. 3. Changes in the following measures of attitudes related to drinking: Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES), Comprehensive Effects of Alcohol (COEA) scale, Obsessive Compulsive Drinking Scale (OCDS), Alcohol Craving Questionnaire (ACQ-NOW) and Alcohol Use Disorders Identification Test (AUDIT). These are assessed at Day 1, Day 10, 2 week, 3-month, 6 month and 9-month follow-up time points. 4. Electronic pressure algometry as a measure of pain threshold, performed on Day 1, Day 3 and Day 10 will be collected to assess an exploratory learning model of pain and its possible disruption through memory mechanisms". This is operationalized as threshold pressure in Newtons. 5. The following measures are potentially important covariate or cofounding factors that we wish to assess for similarity between groups at baseline, but which are not outcomes for study. No specific predictions are made about changes or group differences in these measures: Family history of alcoholism, Lifetime cumulative drinking questionnaire, Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES), The Beck Depression Inventory (BDI), Barratt Impulsiveness Scale (BIS), Behavioural Inhibition/Activation Scale (BIS/BAS)4, Distress Tolerance Scale (DTS), Positive and Negative Affect Scale (PANAS), Alcohol Use Disorders Identification Test (AUDIT) 5.1. Acute responses to drug/placebo infusion as assessed by the Clinician Administered Dissociative States Scales (CADSS), Bodily Symptoms Scale (BSS), Drug Effects Questionnaire (DEQ) and Snaith-Hamilton Pleasure Scale (SHAPS). | — |
Countries
United Kingdom