Clinical TrialAlcohol Use Disorder (AUD)DMTDMTPlaceboPlaceboActive not recruiting

Understanding Neuroplasticity Induced by TrYptamines (UNITy): the effects of dimethyltryptamine (DMT) on drinking

Randomised, double-blind, placebo-controlled 2×2 factorial mechanistic study (n=120) testing 25 mg IV DMT vs placebo combined with alcohol memory reactivation in non-treatment-seeking hazardous/harmful drinkers.

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Target Enrollment
120 participants
Study Type
Phase NA interventional
Design
Randomized, double Blind

Detailed Description

A 2×2 factorial randomised, double-blind mechanistic trial evaluates 25 mg IV N,N‑DMT fumarate or placebo given as a single 10 ml infusion (10 minutes) crossed with an alcohol memory reactivation versus control memory procedure in non-treatment-seeking excessive drinkers.

Primary outcome is mean alcohol consumption (g EtOH/day) by TLFB at baseline and follow-ups; secondary measures include blood phosphatidylethanol, cue-reactivity fMRI, craving questionnaires and daily EMA of consumption and craving.

Neuroimaging and mechanistic biomarkers (fMRI cue reactivity, neural connectivity) and safety/tolerability are assessed with follow-ups to 36 weeks; anonymised data and code will be shared via open repositories.

Study Protocol

Preparation

sessions

Dosing

1 sessions
10 min each

Integration

sessions

Study Arms & Interventions

DMT + alcohol memory

experimental

IV DMT (25 mg) combined with alcohol memory reactivation procedure.

Interventions

  • DMT25 mg
    via IV• single dose• 1 doses total

    25 mg N,N‑DMT fumarate in 10 ml (2.5 mg/ml) infused over 10 minutes.

DMT + control memory

experimental

IV DMT (25 mg) combined with control memory reactivation.

Interventions

  • DMT25 mg
    via IV• single dose• 1 doses total

    25 mg DMT fumarate in 10 ml infused over 10 minutes.

Placebo + alcohol memory

inactive

IV placebo buffer with alcohol memory reactivation.

Interventions

  • Placebo ml
    via IV• single dose• 1 doses total

    10 ml buffer placebo infused over 10 minutes.

Placebo + control memory

inactive

IV placebo buffer with control memory reactivation.

Interventions

  • Placebo ml
    via IV• single dose• 1 doses total

    10 ml buffer placebo infused over 10 minutes.

Participants

Ages
21 – 65
Sexes
Male & Female

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

  • 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 <18 or >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

Study Protocol, Arms & Participants

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Study Details

Locations

Clinical Psychopharmacology Unit — London, United Kingdom

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