Alcohol consumption, cue reactivity, craving and neural connectivity in non-treatment-seeking excessive (hazardous/harmful) alcohol drinking Mental and Behavioural Disorders
Conditions
Interventions
Drugs:
1. Active drug: 25 mg N,N -Dimethyltryptamine fumarate, administered as 10 ml 2.5 mg/ml solution in buffer, intravenously over 10 minutes
2. Placebo: equal volume (10 ml) buffer solution, admin
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 21 - 65 years 2. Normal or corrected-to-normal vision and hearing 3. Fluent English 4. Scoring >10 on the AUDIT questionnaire 5. Drinking =3 times a week 6. Drinking >20 UK units (160g etOH) per week for women or >35 UK units (280g etOH) per week for men; equivalent to = WHO ’moderate risk’ criteria 7. Motivated to reduce consumption based on the Motivation to Reduce Alcohol Consumption (MRAC) Scale
Exclusion criteria
Exclusion criteria: 1. Currently seeking or receiving treatment for alcohol use disorder (AUD) or other substance use disorders (SUDs) 2. Any current major mental health, neurological or physical health disorder 3. BMI 35 kg/m² 4. Severe alcohol dependence as assessed by Severity of Alcohol Dependence Questionnaire (SADQ) 5. Personal or family history of psychosis or schizophrenia 6. Personality disorder (assessed by Structured Assessment of Personality Abbreviated Scale [SAPAS] and clinical psychologist screening) 7. Lifetime trauma exposure (assessed by Stressful Life Events Screening Questionnaire [SLESQ]) 8. >3 lifetime uses of DMT 9. Use of psychedelics within the past 6 months / any regular lifetime use 10. Regular use (> 2x /month) of psychoactive drugs other than nicotine, alcohol or caffeine 11. Contraindications to MRI 12. Known contraindication to psychedelic drugs 13. Current participation in other psychedelics or alcohol studies 14. Prior participation in similar studies within the UCL Clinical Psychopharmacology Unit 15. Previous familiarity with movies used in MRI scanning
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 09/08/2024: Alcohol consumption (mean g EtOH/day) measured by self-report timeline-follow-back (TLFB) of the prior two weeks’ consumption at dosing - 7 days (baseline), + 14 days (post-intervention) and +28 days (1-month post-intervention). Follow-up timepoints are at +12 weeks, +24 weeks and +36 weeks. Timepoints may not be exact due to scheduling constraints but aim to be +/- 2 days from those above. Previous primary outcome measure: Alcohol consumption (mean g EtOH/day) measured by self-report timeline-follow-back (TLFB) at – 7 days (baseline), + 7 days (post-intervention) and +28 days (1-month post-intervention), with follow-up at +12 weeks, +24 weeks and +36 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 09/08/2024: 1. Blood phosphatidylethanol (pEth) levels measured by dried blood spot analysis at baseline, post-intervention (+14 days) and +28 days, with follow-up at + 12 weeks, +24 weeks and +36 weeks 2. Neural alcohol cue reactivity measured via cue reactivity fMRI task at baseline and +14 days 3. Subjective alcohol cue reactivity measured via exposure to in vivo cues at baseline and +14 days 4. Alcohol craving measured with the alcohol craving questionnaire (ACQ) at baseline, +14 days and +28 days with follow-up at + 12 weeks, +24 weeks and +36 weeks. 5. Daily alcohol consumption measured via smartphone ecological momentary assessment response (EMA) at -baseline, +14 days and +28 days with follow-up at + 12 weeks, +24 weeks and +36 weeks 6. Daily alcohol craving measured via daily smartphone VAS at -baseline, +14 days and +28 days with follow-up at + 12 weeks, +24 weeks and +36 weeks Timepoints may not be exact due to scheduling constraints, but aim to be +/- 2 days from those above. Previous secondary outcome measures: 1. Phosphatidylethanol (pEth) levels measured by dried blood spot analysis at baseline, +7 days and +28 days, with follow-up at + 12 weeks, +24 weeks and +36 weeks 2. Neural alcohol cue reactivity measured via cue reactivity fMRI task at baseline and +7 days 3. Subjective alcohol cue reactivity measured via exposure to in vivo cues at baseline and +7 days 4. Alcohol craving measured with the alcohol craving questionnaire (ACQ) at baseline, +7 days and +28 days with follow-up at + 12 weeks, +24 weeks and +36 weeks. 5. Daily alcohol consumption measured via smartphone ecological momentary assessment response (EMA) at -baseline, +7 days and +28 days with follow-up at + 12 weeks, +24 weeks and +36 weeks 6. Daily alcohol craving measured via daily smartphone VAS at -baseline, +7 days and +28 days with follow-up at + 12 weeks, +24 weeks and +36 weeks | — |
Countries
England, United Kingdom
Contacts
Public ContactGregory Cooper
Outcome results
None listed