Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05474989
Other study ID # 2022-00121
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date June 1, 2024
Est. completion date May 1, 2028

Study information

Verified date October 2023
Source University Hospital, Basel, Switzerland
Contact Felix Müller, PD Dr. med.
Phone +41 (0)61 325 5111
Email felix.mueller@upk.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Alcohol use causes more overall harm than any other drug and is the seventh leading risk factor for both deaths and disability-adjusted life years. Alcohol use disorders (AUD) are among the most common and undertreated mental disorders in developed countries. Pharmacological and psychotherapeutic treatments only show limited efficacy and around 60% of the patients relapse in the short-term after withdrawal. Lysergic acid diethylamide (LSD) was investigated in numerous clinical trials during the 1950s and 1960s. Specifically, the use of LSD in the treatment of AUD was investigated extensively. A pooled analysis of six historical clinical trials demonstrated, that a single dose of LSD significantly reduced alcohol use at three and six months after LSD administration. However, these trials are limited by several factors, including the use of diagnostic standards that are no longer not up to date, single, high-dose treatment regimes, missing biological assessment for alcohol use, and no consequent assessment of blinding. Therefore, the present study aims to evaluate the safety and efficacy of LSD for the treatment of AUD and addresses the shortcomings of previous studies. The trial has a double-blind, active placebo-controlled, randomized, parallel design and will be conducted in specialized treatment centers for addictive disorders in Switzerland. The study will include 126 patients after withdrawal treatment and will primarily assess the efficacy of LSD for the treatment of AUD. Patients will be treated using a 1:1 allocation. Each arm will last 20 weeks and will comprise nine study visits without drug administration and two study days involving LSD or active placebo administration. In the first session, patients in the treatment group will receive a dose of 150 µg LSD, followed by another 150 µg or 250 µg LSD in the second session, which will take place approximately 4 weeks after the first session. The primary outcome is the mean of percent heavy drinking days after administration of two doses of LSD at 3 months follow-up. Additionally, the study will assess neurobiological mechanisms of action and several other measures.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 126
Est. completion date May 1, 2028
Est. primary completion date May 1, 2028
Accepts healthy volunteers No
Gender All
Age group 25 Years and older
Eligibility Key inclusion criteria: - age = 25 years - moderate to severe AUD - completion of a qualified detoxification for AUD within 30 days prior to screening - a minimum of 4 heavy drinking days within the last 30 days before detoxification - intention to stop or decrease drinking Key exclusion criteria: - significant alcohol withdrawal symptoms at screening - participating or starting in any formal treatment for AUD until completion of visit 9 - cognitive impairment - borderline personality disorder - current post-traumatic stress disorder - current suicidality or history of a serious suicide attempt - significant prodromal symptoms - history of a diagnosis of a psychotic or bipolar disorder in subjects or first-degree relatives - pregnancy or breast-feeding - lack of safe contraception are exclusion criterion for women only

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
LSD
Moderate to high dose LSD
Active placebo
Low dose LSD

Locations

Country Name City State
Switzerland University Hospital of Psychiatry, University of Basel Basel
Switzerland University Hospital of Psychiatry, University of Bern Bern

Sponsors (2)

Lead Sponsor Collaborator
Felix Mueller University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percent heavy drinking days The primary outcome is the mean of percent heavy drinking days after administration of two doses of LSD assessed with the alcohol timeline follow-back (TLFB) questionnaire compared between treatment groups Period of three months after the second intervention
Secondary Cortical thickness measured with MRI Changes in the cortical thickness of ACC, PCC, and PFC Two weeks before first administration, two and 12 weeks after second administration
Secondary The volume of the striatum measured with MRI Changes in the volume of the striatum Two weeks before first administration, two and 12 weeks after second administration
Secondary White matter microstructure measured with MRI Changes in white matter microstructure in the cingulum bundle and the PFC-striatal connection pathway Two weeks before first administration, two and 12 weeks after second administration
Secondary Days to first heavy drinking day Days to first heavy drinking day after first and second administration assessed with TLFB Three months after the second intervention
Secondary Days to first drinking day Days to first drinking day assessed after first and second administration assessed with TLFB Three months after the second intervention
Secondary Percent days abstinent Percent days abstinent after first and second administration assessed with TLFB Three months after the second intervention
Secondary Drinks per drinking day Drinks per drinking day after first and second administration assessed with TLF Three months after the second intervention
Secondary Adverse consequences of alcohol use Adverse consequences of alcohol use assessed with Short Inventory of Problems Three months after the second intervention
Secondary Craving Craving assessed with Obsessive Compulsive Drinking Scale Three months after the second intervention
Secondary Ethyl glucuronide Ethyl glucuronide (EtG) in hair Screening and three months after the second intervention
Secondary Phosphatidylethanol Phosphatidylethanol (PEth) in blood Screening, day of first intervention, day of second intervention, three months after the second intervention
Secondary General health General health assessed with General Health Questionnaire Three months after the second intervention
Secondary Depression Hamilton Depression Rating Scale Three months after the second intervention
Secondary Anxiety Beck Anxiety Inventory Three months after the second intervention
Secondary Blinding Blinding will be assessed directly after each session by asking patients and therapists to guess the group assignment ("high dose", "low dose", "don't know") and to provide their degree of certainty (using a visual analogue scale) of their guess. In the evening after administration 1 (week 4) and administration 2 (week 8), respectively
Secondary Safety: Adverse events Adverse events will be documented at each visit and each session. Week 0 to week 20
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04927364 - Examining the Effectiveness of Deep TMS in Veterans With Alcohol Use Disorder N/A
Active, not recruiting NCT04618653 - Comprehensive Process Model of AA-related Behavior Change
Recruiting NCT05471154 - Non-invasive Brain Stimulation of the Prefrontal Cortex in Substance Use Disorders N/A
Completed NCT05021640 - Study of DCR-AUD in Healthy Volunteers Phase 1
Not yet recruiting NCT05064228 - Mobile Rewarding Activity Centered Treatment N/A
Completed NCT04958655 - Mental Imagery Intervention for Alcohol Craving N/A
Completed NCT05252221 - Alcohol Telemedicine Consultation in Primary Care (ATC) N/A
Completed NCT06108115 - Smartphone-Based Intervention for Sleep Disturbance in Individuals Recovering From Alcohol Use Disorder N/A
Not yet recruiting NCT06303778 - Combining a Smartphone App With Medications to Manage Heavy Drinking N/A
Completed NCT04639895 - Cognitive Rehabilitation Through Personalized Virtual Reality and Paper-and-pencil Interventions in the Alcohol Use Disorder Treatment. N/A
Completed NCT02911285 - NAC for Treating Comorbid PTSD and SUD Phase 2
Recruiting NCT04598399 - Comparison of the Effectiveness of Two Psycho-physical Interventions: Mindfulness Based Relapse Prevention (MBRP) and Unguided Meditative Relaxation in Patients With Alcohol Use Disorder N/A
Completed NCT04827056 - Effect of Sublingual Formulation of Dexmedetomidine HCl (BXCL501) - Alcohol Interaction Study Phase 1
Completed NCT04974645 - Pilot: Digital Therapeutic vs Education for the Management of Problematic Substance Use N/A
Recruiting NCT05992272 - Cue Effects in Human Addiction: Pavlovian to Instrumental Transfer
Completed NCT04229095 - Medication Development in Alcoholism: Suvorexant Versus Placebo Phase 2
Recruiting NCT05534568 - The Oklahoma Parent-Child Assistance Program N/A
Completed NCT04925570 - The Anchor Study: Digitally Delivered Intervention for Reducing Problematic Substance Use Phase 2
Active, not recruiting NCT05492942 - Records for Alcohol Care Enhancement N/A
Recruiting NCT05015881 - Relationship Between Brain and Heart Glucose Metabolism in Alcohol Use Disorder Phase 2/Phase 3