Clinical TrialParallelAlcohol Use Disorder (AUD)LSDCompleted

A clinical study of LSD treatment in alcoholism

Randomized controlled three-year investigation comparing three LSD treatment conditions (hypnodelic, psychedelic, and drug-alone) against a milieu therapy control in 176 male alcoholic inpatients at Mendota State Hospital, Wisconsin. All groups improved significantly across all follow-up periods; no LSD condition outperformed the control.

Target Enrollment
176 participants
Study Type
Phase NA interventional
Design
Randomized, single Blind
Registry
Not listed

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Detailed Description

A three-year randomized controlled investigation designed to determine whether any of three LSD treatment conditions would outperform a milieu-only control for male alcoholic inpatients, and whether adding post-discharge disulfiram could enhance any treatment's effect.

176 male alcoholic patients at the Alcoholic Treatment Center (ATC), Mendota State Hospital, Madison, Wisconsin were randomly assigned to one of four conditions: (1) Hypnodelic Therapy (LSD + hypnosis + psychotherapy), (2) Psychedelic Therapy (LSD + psychotherapy), (3) Drug Alone (LSD only), or (4) Milieu Therapy / No Therapy (control). 44 patients per arm. Half of each group (n=22) were additionally assigned disulfiram (0.5g/day orally) for up to 12 months post-discharge, creating a 2×4 factorial design.

All LSD conditions used a single oral dose of 3 µg/kg body weight in a ~3-hour morning session. A standardized ~2-hour preparatory session preceded treatment for all participants. Thirteen psychiatrists served as therapists, each trained in hypnosis and LSD administration and balanced across conditions. Following each session, patients were observed overnight in a dedicated observation room with nursing supervision, vital sign monitoring, and sedation as needed.

Outcome was assessed at inpatient (pre-treatment and ~2 weeks post-treatment) and at 3, 6, 9, and 12 months post-discharge using the Psychiatric Evaluation Profile (PEP), California Psychological Inventory (CPI), Breathalyzer, Drinking Follow-up Form (DFF), and Behavior Rating Scale (BRS, also rated by relatives). Follow-up rates exceeded 87% at all time points.

All four groups showed statistically significant improvement from baseline across most measures at both inpatient and follow-up evaluations. However, no treatment condition was superior to any other. Approximately 65% of patients had returned to drinking by 3 months and 80–90% by 12 months. Disulfiram assignment made no significant difference in any outcome measure. The authors concluded that LSD treatment procedures offered no therapeutic advantage over the standard milieu program.

Note: This trial predates clinical trial registration systems and has no registry entry. Details derived from Ludwig et al. (1969), American Journal of Psychiatry, 126(1):59–69.

Study Protocol

Preparation

1 sessions
120 min each

Dosing

1 sessions
180 min each

Integration

0 sessions

Therapeutic Protocol

psychodynamicsupportive

Study Arms & Interventions

LSD 210 µg/70 kg (with hypnosis)

experimental

LSD (3 µg/kg body weight, oral) administered at session start, followed by a 30–45 min hypnotic induction aimed at deep trance, then active dynamically oriented psychotherapy targeting the patient's major problem areas for the remainder of the ~3-hour session. Hypnotic control was periodically reinforced throughout. Post-session: observation room for the rest of the day and overnight, with nursing supervision, vital signs, and sedation as needed.

Interventions

  • LSD3 mcg/kg
    via OralSingle session1 doses total

LSD 210 µg/70 kg (with psychotherapy)

experimental

LSD (3 µg/kg body weight, oral) administered at session start; patients instructed to talk about their problems while therapist engaged in active dynamically oriented psychotherapy throughout the ~3-hour session — identical therapeutic style to the hypnodelic arm but without hypnosis. Post-session: same observation room protocol.

Interventions

  • LSD3 mcg/kg
    via OralSingle session1 doses total

LSD 210 µg/70 kg

experimental

LSD (3 µg/kg body weight, oral) administered at session start; patients instructed to relax and independently work through their problems. Therapist remained present in the room throughout the ~3-hour session but was not to initiate dialogue — only brief support if the patient became anxious or panicky. Post-session: same observation room protocol.

Interventions

  • LSD3 mcg/kg
    via OralSingle session1 doses total

Milieu Therapy / No Therapy (Control)

no intervention

No drug or active psychotherapy administered. Patients spent an equivalent amount of time in the treatment room in 'contemplation and meditation,' asked to conduct an honest personal inventory, write down the reasons for their problems, and make constructive plans for the future. Represents the standard milieu treatment program of the ATC (therapeutic community meetings, small group therapy, AA, work assignments, recreational and occupational therapy, individual counseling).

Participants

Ages
2155
Sexes
male

Inclusion Criteria

  • 1) Between the ages of 21 and 55; 2) Up to four previous admissions to Mendota State Hospital for alcoholism; 3) No overt psychosis; 4) No evidence of serious neurological or physical disability; 5) Contact with a responsible relative (who was not over 70 years old) within one year; 6) Residence within a specified geographical area.

Exclusion Criteria

  • Overt psychosis; serious neurological or physical disability; no contact with a responsible relative within one year (or relative over age 70); residence outside the specified geographical area; more than four previous admissions to Mendota State Hospital for alcoholism. (Exclusion criteria as implied by stated inclusion criteria in the paper.)

Study Protocol, Arms & Participants

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Study Details

  • Status
    Completed
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Randomizedsingle Blind
  • Target Enrollment176 participants
  • Timeline
    Start: 1966-01-01
    End: 1968-12-31
  • Compound
  • Topic

Locations

Alcoholic Treatment Center (ATC), Mendota State HospitalMadison, Wisconsin, United States

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