Trial Outcomes & Findings for Lysergic Acid Diethylamide (LSD)-Assisted Psychotherapy in People With Illness-related Anxiety (NCT NCT00920387)

NCT ID: NCT00920387

Last Updated: 2023-07-12

Results Overview

The STAI differentiates between State Anxiety, defined as "anxiety experienced in reaction to a specific environmental circumstance," and Trait Anxiety, defined as "long-standing nervous affect or anxiety disorder." The STAI-state subscale is a 20-item self-reported scale which assesses subjects' levels of transient, situationally oriented, anxiety. Participants respond to each item by selecting a response from a 4-point Likert scale ranging from 4 ("Not at all") to 1 ("Very much so"). STAI-state scores are summed for a total score that range from 20 to 80, with higher scores indicating greater state anxiety. The STAI-trait subscale also consists of 20-items and is scored the same way, with total scores ranging from 20 to 80, with higher scores indicating greater trait anxiety.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

Baseline (Visit 4)

Results posted on

2023-07-12

Participant Flow

Participants were recruited through general information about the study reported in media, by flyers, presentations in hospitals or cancer support groups, or referral from other physicians.

Participant milestones

Participant milestones
Measure	Full Dose LSD (200 mcg) Blinded Stage 1 200 mcg LSD administered once during each of two blinded LSD-assisted therapy sessions, scheduled two to four weeks apart during Stage 1 200 mcg LSD: Administering 200 mcg LSD orally once at the start of each of two day-long psychotherapy session Therapy: Therapy provided by male and female co-therapists	Active Placebo LSD (20 mcg) Stage 1 20 mcg LSD administered once during each of two blinded LSD-assisted therapy sessions, scheduled two to four weeks apart during Stage 1. 20 mcg LSD: Administer 20 mcg LSD orally once at the start of each of two day-long psychotherapy session Therapy: Therapy provided by male and female co-therapists	Full Dose LSD (200 mcg) Open-Label Stage 2 200 mcg LSD administered open-label once during two experimental sessions, scheduled two to eight weeks apart during Stage 2
Stage 1 STARTED	8	4	0
Stage 1 COMPLETED	7	4	0
Stage 1 NOT COMPLETED	1	0	0
Stage 2 STARTED	0	0	3
Stage 2 COMPLETED	0	0	3
Stage 2 NOT COMPLETED	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Full Dose LSD (200 mcg) Blinded Stage 1 200 mcg LSD administered once during each of two blinded LSD-assisted therapy sessions, scheduled two to four weeks apart during Stage 1 200 mcg LSD: Administering 200 mcg LSD orally once at the start of each of two day-long psychotherapy session Therapy: Therapy provided by male and female co-therapists	Active Placebo LSD (20 mcg) Stage 1 20 mcg LSD administered once during each of two blinded LSD-assisted therapy sessions, scheduled two to four weeks apart during Stage 1. 20 mcg LSD: Administer 20 mcg LSD orally once at the start of each of two day-long psychotherapy session Therapy: Therapy provided by male and female co-therapists	Full Dose LSD (200 mcg) Open-Label Stage 2 200 mcg LSD administered open-label once during two experimental sessions, scheduled two to eight weeks apart during Stage 2
Stage 1 Adverse Event	1	0	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Full Dose LSD (200 mcg) n=8 Participants 200 mcg LSD administered once during each of two LSD-assisted therapy sessions, scheduled two to four weeks apart. 200 mcg LSD: Administering 200 mcg LSD orally once at the start of each of two day-long psychotherapy session Therapy: Therapy provided by male and female co-therapists	Active Placebo LSD (20 mcg) n=3 Participants 20 mcg LSD administered once during each of two LSD-assisted therapy sessions, scheduled two to four weeks apart. 20 mcg LSD: Administer 20 mcg LSD orally once at the start of each of two day-long psychotherapy session Therapy: Therapy provided by male and female co-therapists	Total n=11 Participants Total of all reporting groups
Age, Continuous	49.6 years STANDARD_DEVIATION 8.4 • n=8 Participants	57.4 years STANDARD_DEVIATION 9.9 • n=3 Participants	51.7 years STANDARD_DEVIATION 9.1 • n=11 Participants
Sex: Female, Male Female	3 Participants n=8 Participants	1 Participants n=3 Participants	4 Participants n=11 Participants
Sex: Female, Male Male	5 Participants n=8 Participants	2 Participants n=3 Participants	7 Participants n=11 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
History of suicidal tendencies None	8 Participants n=8 Participants	1 Participants n=3 Participants	9 Participants n=11 Participants
History of suicidal tendencies Mild	0 Participants n=8 Participants	2 Participants n=3 Participants	2 Participants n=11 Participants
Type of life-threatening illness Metastatic breast carcinoma	3 Participants n=8 Participants	1 Participants n=3 Participants	4 Participants n=11 Participants
Type of life-threatening illness Metastatic gastric carcinoma	2 Participants n=8 Participants	0 Participants n=3 Participants	2 Participants n=11 Participants
Type of life-threatening illness Plasmocytoma	1 Participants n=8 Participants	0 Participants n=3 Participants	1 Participants n=11 Participants
Type of life-threatening illness Non-Hodgkin's Lymphoma	0 Participants n=8 Participants	1 Participants n=3 Participants	1 Participants n=11 Participants
Type of life-threatening illness Celiac Disease	0 Participants n=8 Participants	1 Participants n=3 Participants	1 Participants n=11 Participants
Type of life-threatening illness Parkinson's Disease	1 Participants n=8 Participants	0 Participants n=3 Participants	1 Participants n=11 Participants
Type of life-threatening illness Bechterew's Disease	1 Participants n=8 Participants	0 Participants n=3 Participants	1 Participants n=11 Participants

PRIMARY outcome

Timeframe: Baseline (Visit 4)

Outcome measures

Outcome measures
Measure	Full Dose LSD (200 mcg) n=8 Participants 200 mcg LSD administered once during each of two LSD-assisted therapy sessions, scheduled two to four weeks apart. 200 mcg LSD: Administering 200 mcg LSD orally once at the start of each of two day-long psychotherapy session Therapy: Therapy provided by male and female co-therapists	Active Placebo LSD (20 mcg) n=3 Participants 20 mcg LSD administered once during each of two LSD-assisted therapy sessions, scheduled two to four weeks apart. 20 mcg LSD: Administer 20 mcg LSD orally once at the start of each of two day-long psychotherapy session Therapy: Therapy provided by male and female co-therapists
Baseline State-Trait Anxiety Inventory (STAI) STAI-state	53.1 score on a scale Standard Deviation 4.7	47.7 score on a scale Standard Deviation 7.7
Baseline State-Trait Anxiety Inventory (STAI) STAI-trait	53.2 score on a scale Standard Deviation 4.3	43.3 score on a scale Standard Deviation 7.0

PRIMARY outcome

Timeframe: 2 months after second experimental session

Outcome measures

Outcome measures
Measure	Full Dose LSD (200 mcg) n=8 Participants 200 mcg LSD administered once during each of two LSD-assisted therapy sessions, scheduled two to four weeks apart. 200 mcg LSD: Administering 200 mcg LSD orally once at the start of each of two day-long psychotherapy session Therapy: Therapy provided by male and female co-therapists	Active Placebo LSD (20 mcg) n=3 Participants 20 mcg LSD administered once during each of two LSD-assisted therapy sessions, scheduled two to four weeks apart. 20 mcg LSD: Administer 20 mcg LSD orally once at the start of each of two day-long psychotherapy session Therapy: Therapy provided by male and female co-therapists
Primary Endpoint State-Trait Anxiety Inventory (STAI) STAI-state	41.5 score on a scale Standard Deviation 3.2	51.7 score on a scale Standard Deviation 5.3
Primary Endpoint State-Trait Anxiety Inventory (STAI) STAI-trait	45.2 score on a scale Standard Deviation 3.7	49.0 score on a scale Standard Deviation 6.1

Adverse Events

Full Dose LSD (200 mcg Stage 1)

Serious events: 1 serious events

Other events: 8 other events

Deaths: 1 deaths

Active Placebo LSD (20 mcg Stage 1)

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Full Dose LSD (200 mcg Stage 2)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Full Dose LSD (200 mcg Stage 1) n=8 participants at risk 200 mcg LSD administered once during each of two LSD-assisted therapy sessions, scheduled two to four weeks apart. 200 mcg LSD: Administering 200 mcg LSD orally once at the start of each of two day-long psychotherapy session Therapy: Therapy provided by male and female co-therapists	Active Placebo LSD (20 mcg Stage 1) n=4 participants at risk 20 mcg LSD administered once during each of two LSD-assisted therapy sessions, scheduled two to four weeks apart. 20 mcg LSD: Administer 20 mcg LSD orally once at the start of each of two day-long psychotherapy session Therapy: Therapy provided by male and female co-therapists	Full Dose LSD (200 mcg Stage 2) n=3 participants at risk 200 mcg LSD administered once during each of two LSD-assisted therapy sessions, scheduled two to eight weeks apart. 200 mcg LSD: Administering 200 mcg LSD orally once at the start of each of two day-long psychotherapy session Therapy: Therapy provided by male and female co-therapists
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastic Esophageal Cancer	12.5% 1/8 • From enrollment to end of Stage 2 (approximately 11 months)	0.00% 0/4 • From enrollment to end of Stage 2 (approximately 11 months)	0.00% 0/3 • From enrollment to end of Stage 2 (approximately 11 months)
Renal and urinary disorders Pyelonephritis	0.00% 0/8 • From enrollment to end of Stage 2 (approximately 11 months)	25.0% 1/4 • From enrollment to end of Stage 2 (approximately 11 months)	0.00% 0/3 • From enrollment to end of Stage 2 (approximately 11 months)

Other adverse events

Additional Information

Berra Yazar-Klosinski, PhD / Chief Scientific Officer

Multidisciplinary Association for Psychedelic Studies (MAPS) Public Benefit Corp.

Phone: (831) 429-6362

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Full Dose LSD (200 mcg Stage 1) n=8 participants at risk 200 mcg LSD administered once during each of two LSD-assisted therapy sessions, scheduled two to four weeks apart. 200 mcg LSD: Administering 200 mcg LSD orally once at the start of each of two day-long psychotherapy session Therapy: Therapy provided by male and female co-therapists	Active Placebo LSD (20 mcg Stage 1) n=4 participants at risk 20 mcg LSD administered once during each of two LSD-assisted therapy sessions, scheduled two to four weeks apart. 20 mcg LSD: Administer 20 mcg LSD orally once at the start of each of two day-long psychotherapy session Therapy: Therapy provided by male and female co-therapists	Full Dose LSD (200 mcg Stage 2) n=3 participants at risk 200 mcg LSD administered once during each of two LSD-assisted therapy sessions, scheduled two to eight weeks apart. 200 mcg LSD: Administering 200 mcg LSD orally once at the start of each of two day-long psychotherapy session Therapy: Therapy provided by male and female co-therapists
Infections and infestations Pneumonia	12.5% 1/8 • From enrollment to end of Stage 2 (approximately 11 months)	0.00% 0/4 • From enrollment to end of Stage 2 (approximately 11 months)	0.00% 0/3 • From enrollment to end of Stage 2 (approximately 11 months)
Injury, poisoning and procedural complications Femur Fracture	12.5% 1/8 • From enrollment to end of Stage 2 (approximately 11 months)	0.00% 0/4 • From enrollment to end of Stage 2 (approximately 11 months)	0.00% 0/3 • From enrollment to end of Stage 2 (approximately 11 months)
Nervous system disorders Headache	12.5% 1/8 • From enrollment to end of Stage 2 (approximately 11 months)	0.00% 0/4 • From enrollment to end of Stage 2 (approximately 11 months)	0.00% 0/3 • From enrollment to end of Stage 2 (approximately 11 months)
Reproductive system and breast disorders Menorrhagia	12.5% 1/8 • From enrollment to end of Stage 2 (approximately 11 months)	0.00% 0/4 • From enrollment to end of Stage 2 (approximately 11 months)	0.00% 0/3 • From enrollment to end of Stage 2 (approximately 11 months)
Skin and subcutaneous tissue disorders Palmar-plantar Erythrody Saesthesia Syndrome	12.5% 1/8 • From enrollment to end of Stage 2 (approximately 11 months)	0.00% 0/4 • From enrollment to end of Stage 2 (approximately 11 months)	0.00% 0/3 • From enrollment to end of Stage 2 (approximately 11 months)
Blood and lymphatic system disorders Anemia	12.5% 1/8 • From enrollment to end of Stage 2 (approximately 11 months)	0.00% 0/4 • From enrollment to end of Stage 2 (approximately 11 months)	0.00% 0/3 • From enrollment to end of Stage 2 (approximately 11 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	12.5% 1/8 • From enrollment to end of Stage 2 (approximately 11 months)	0.00% 0/4 • From enrollment to end of Stage 2 (approximately 11 months)	0.00% 0/3 • From enrollment to end of Stage 2 (approximately 11 months)
Skin and subcutaneous tissue disorders Skin Lesion	0.00% 0/8 • From enrollment to end of Stage 2 (approximately 11 months)	25.0% 1/4 • From enrollment to end of Stage 2 (approximately 11 months)	0.00% 0/3 • From enrollment to end of Stage 2 (approximately 11 months)
Psychiatric disorders Anxiety	25.0% 2/8 • From enrollment to end of Stage 2 (approximately 11 months)	50.0% 2/4 • From enrollment to end of Stage 2 (approximately 11 months)	33.3% 1/3 • From enrollment to end of Stage 2 (approximately 11 months)
Psychiatric disorders Anger	12.5% 1/8 • From enrollment to end of Stage 2 (approximately 11 months)	50.0% 2/4 • From enrollment to end of Stage 2 (approximately 11 months)	0.00% 0/3 • From enrollment to end of Stage 2 (approximately 11 months)
Nervous system disorders Disturbance in Attention	0.00% 0/8 • From enrollment to end of Stage 2 (approximately 11 months)	25.0% 1/4 • From enrollment to end of Stage 2 (approximately 11 months)	0.00% 0/3 • From enrollment to end of Stage 2 (approximately 11 months)
General disorders Feeling Cold	75.0% 6/8 • From enrollment to end of Stage 2 (approximately 11 months)	0.00% 0/4 • From enrollment to end of Stage 2 (approximately 11 months)	33.3% 1/3 • From enrollment to end of Stage 2 (approximately 11 months)
Psychiatric disorders Affect Liability	12.5% 1/8 • From enrollment to end of Stage 2 (approximately 11 months)	25.0% 1/4 • From enrollment to end of Stage 2 (approximately 11 months)	33.3% 1/3 • From enrollment to end of Stage 2 (approximately 11 months)
Psychiatric disorders Emotional Distress	62.5% 5/8 • From enrollment to end of Stage 2 (approximately 11 months)	25.0% 1/4 • From enrollment to end of Stage 2 (approximately 11 months)	0.00% 0/3 • From enrollment to end of Stage 2 (approximately 11 months)
Psychiatric disorders Time Perception Altered	50.0% 4/8 • From enrollment to end of Stage 2 (approximately 11 months)	0.00% 0/4 • From enrollment to end of Stage 2 (approximately 11 months)	66.7% 2/3 • From enrollment to end of Stage 2 (approximately 11 months)
Psychiatric disorders Thinking Abnormal	12.5% 1/8 • From enrollment to end of Stage 2 (approximately 11 months)	25.0% 1/4 • From enrollment to end of Stage 2 (approximately 11 months)	0.00% 0/3 • From enrollment to end of Stage 2 (approximately 11 months)
Psychiatric disorders Perseveration	0.00% 0/8 • From enrollment to end of Stage 2 (approximately 11 months)	0.00% 0/4 • From enrollment to end of Stage 2 (approximately 11 months)	33.3% 1/3 • From enrollment to end of Stage 2 (approximately 11 months)
Psychiatric disorders Tachyphrenia	0.00% 0/8 • From enrollment to end of Stage 2 (approximately 11 months)	25.0% 1/4 • From enrollment to end of Stage 2 (approximately 11 months)	0.00% 0/3 • From enrollment to end of Stage 2 (approximately 11 months)
Psychiatric disorders Feeling Abnormal	62.5% 5/8 • From enrollment to end of Stage 2 (approximately 11 months)	50.0% 2/4 • From enrollment to end of Stage 2 (approximately 11 months)	33.3% 1/3 • From enrollment to end of Stage 2 (approximately 11 months)
Psychiatric disorders Derealization	12.5% 1/8 • From enrollment to end of Stage 2 (approximately 11 months)	0.00% 0/4 • From enrollment to end of Stage 2 (approximately 11 months)	33.3% 1/3 • From enrollment to end of Stage 2 (approximately 11 months)
Psychiatric disorders Bradyphrenia	12.5% 1/8 • From enrollment to end of Stage 2 (approximately 11 months)	0.00% 0/4 • From enrollment to end of Stage 2 (approximately 11 months)	0.00% 0/3 • From enrollment to end of Stage 2 (approximately 11 months)
Psychiatric disorders Hallucination	12.5% 1/8 • From enrollment to end of Stage 2 (approximately 11 months)	0.00% 0/4 • From enrollment to end of Stage 2 (approximately 11 months)	0.00% 0/3 • From enrollment to end of Stage 2 (approximately 11 months)
Psychiatric disorders Illusions	75.0% 6/8 • From enrollment to end of Stage 2 (approximately 11 months)	25.0% 1/4 • From enrollment to end of Stage 2 (approximately 11 months)	66.7% 2/3 • From enrollment to end of Stage 2 (approximately 11 months)
Eye disorders Mydriasis	37.5% 3/8 • From enrollment to end of Stage 2 (approximately 11 months)	0.00% 0/4 • From enrollment to end of Stage 2 (approximately 11 months)	0.00% 0/3 • From enrollment to end of Stage 2 (approximately 11 months)
Skin and subcutaneous tissue disorders Perspiration	25.0% 2/8 • From enrollment to end of Stage 2 (approximately 11 months)	0.00% 0/4 • From enrollment to end of Stage 2 (approximately 11 months)	0.00% 0/3 • From enrollment to end of Stage 2 (approximately 11 months)
General disorders Impaired Gait	25.0% 2/8 • From enrollment to end of Stage 2 (approximately 11 months)	0.00% 0/4 • From enrollment to end of Stage 2 (approximately 11 months)	66.7% 2/3 • From enrollment to end of Stage 2 (approximately 11 months)
General disorders Feeling of Relaxation	0.00% 0/8 • From enrollment to end of Stage 2 (approximately 11 months)	25.0% 1/4 • From enrollment to end of Stage 2 (approximately 11 months)	0.00% 0/3 • From enrollment to end of Stage 2 (approximately 11 months)
General disorders Asthenia	0.00% 0/8 • From enrollment to end of Stage 2 (approximately 11 months)	25.0% 1/4 • From enrollment to end of Stage 2 (approximately 11 months)	0.00% 0/3 • From enrollment to end of Stage 2 (approximately 11 months)
Psychiatric disorders Depersonalization	0.00% 0/8 • From enrollment to end of Stage 2 (approximately 11 months)	0.00% 0/4 • From enrollment to end of Stage 2 (approximately 11 months)	33.3% 1/3 • From enrollment to end of Stage 2 (approximately 11 months)
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/8 • From enrollment to end of Stage 2 (approximately 11 months)	25.0% 1/4 • From enrollment to end of Stage 2 (approximately 11 months)	0.00% 0/3 • From enrollment to end of Stage 2 (approximately 11 months)
Psychiatric disorders Altered Perception of Music	0.00% 0/8 • From enrollment to end of Stage 2 (approximately 11 months)	25.0% 1/4 • From enrollment to end of Stage 2 (approximately 11 months)	0.00% 0/3 • From enrollment to end of Stage 2 (approximately 11 months)