Clinical TrialLSDPlaceboPlaceboCompleted

Single Oral Lysergide (LSD 500 µg) in Inpatient Alcoholic Rehabilitation: Controlled Evaluation with Schizophrenic Sub-Analysis (Tomsovic & Edwards 1970)

Controlled evaluation of single oral lysergide (LSD) 500 µg in an inpatient 90-day Alcoholic Rehabilitation Programme (Q J Stud Alcohol 1970 Dec; Tomsovic M, Edwards RV; PMID 5490826). n=75 volunteers received lysergide; among these, 23 were classified as schizophrenic. Volunteers paired with contemporaneous admissions; at day 45, one of each pair assigned to lysergide by coin toss (partially randomised). Control group I: volunteers who did not receive lysergide or received placebo substitute. Control group II: routine programme participants who had completed before the project or did not volunteer. Session: single oral 500 µg lysergide in specially furnished room (colourful drapes, pictures, music); patient-chosen nursing assistant present non-directively for 7 h; administering psychiatrist made intermittent visits; preparatory readings and debrief the next day. Primary outcome: drinking control (Drinking Adjustment Scale) at 3, 6, and 12 months; validation by spouses/informants. Secondary: Blewett & Chwelos Scales (acute/subacute reactions); subjective session classification ("good"/"moderate"/"poor"); rates of recrudescence (vivid post-session recurrences). Schizophrenic vs non-schizophrenic sub-analyses. No registration (pre-registration era, 1970). CT.gov: 0 hits.

Target Enrollment
75 participants
Study Type
interventional
Design
Randomized, single Blind

Study Arms & Interventions

Lysergide

experimental

Single oral dose of lysergide (LSD) in a specially furnished room as part of a 90-day rehabilitation program.

Interventions

  • LSD500 µg
    via oralsingle dose1 doses total

    The study included both nonschizophrenic and schizophrenic subgroups.

Control Group I

placebo

Volunteers for the lysergide treatment who did not receive the drug or received a placebo substitute.

Interventions

  • Placebo
    via oralsingle dose1 doses total

    Described as a volunteer control group that may have experienced a deprivation effect.

Control Group II

active comparator

Patients who passed through the regular 90-day Alcoholic Rehabilitation Program but did not volunteer for the lysergide project.

Interventions

  • Placebo

    Standard 90-day rehabilitation program participants.

Primary Results(1 publication)

Participants

N = 343Mean age: 43–45 across armsM. et al. 1970

Adverse Events (from all publications)

Arm / GroupnAny TEAESevereSeriousDiscont.
Lysergideexperimental750(0.0%)
Control Group Iplacebo75
Control Group IIactive_comparator193

* The paper states: 'None of our lysergide-treated patients, to the best of our knowledge, suffered any of these serious aftereffects' (referring to prolonged states of panic, confusion, psychosis, paranoia, and suicidal or homicidal behavior).

* No specific safety data reported for this arm.

Study Details

  • Status
    Completed
  • Type
    interventional
  • Design
    Randomizedsingle Blind
  • Target Enrollment75 participants
  • Timeline
    Start: 1966-01-01
    End: 1970-12-31
  • Compounds

Related Publications

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