Psilocybin for Methamphetamine Addiction
ConditionMethamphetamine Use Disorder
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age25-65
SponsorKevin Murnane
About this trial
The primary purpose of this study is to preliminarily determine if the use of psilocybin to promote abstinence from methamphetamine is feasible and well tolerated in populations such as those found in Northern Louisiana. Investigators will assess the impact of psilocybin-facilitated treatment on methamphetamine abstinence, craving, negative affect, cognitive function and quality of life. Components of the psilocybin experience will also be measured (persisting effects, quality of life, challenging experiences, etc). Investigators will assess feasibility and tolerability as rates of retention and challenging experiences, among other factors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 25-65 at time of signing informed consent
Identification of methamphetamine as drug of choice
Score of at least 3 on the Severity of Dependence Scale
Have been at the designated local treatment facility for at least 7 days
Disqualifiers
Meeting criteria for substance dependence diagnoses other than methamphetamine (except nicotine and cannabis) as assessed by the MINI
History of Hallucinogen Use Disorder or Hallucinogen Persisting Perceptive Disorder
Women who are pregnant, plan to become pregnant, or are breast feeding
Women who do not agree to engage in abstinence or are not using dual contraceptive methods at the time of enrollment and for the study duration
Trial design
Design model
Single group
Treatments tested in this trial
Psilocybin 25 mg
Drug25 mg administered orally (capsules)
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: PsilocybinExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Participant retention rate
Description: Retention in the study will be assessed by measuring the percentage of study visits completed per participant. Measure: * Retention rate (percent of scheduled study visits completed by each participant).
Time frame
Screening, Visit #12
Participant retention rate
Description: Retention in the study will be assessed by measuring the percentage of study visits completed per participant. Measure: * Retention rate (percent of scheduled study visits completed by each participant).
Time frame
Baseline Assessments, Visit #23
Participant retention rate
Description: Retention in the study will be assessed by measuring the percentage of study visits completed per participant. Measure: * Retention rate (percent of scheduled study visits completed by each participant).
Time frame
Preparatory Session #1, Visit #3 (on study day (-)14; 14 days prior to dosing)4
Participant retention rate
Description: Retention in the study will be assessed by measuring the percentage of study visits completed per participant. Measure: * Retention rate (percent of scheduled study visits completed by each participant).
Time frame
Preparatory Session #2, Visit #4 (on study day (-) 7; 7 days prior to dosing)Secondary outcomes
1
Effects of psilocybin on quality of life
Description: Quality of life will be assessed using a validated self-report questionnaire. Measure: * Quality of Life Questionnaire (QOL): Score range = 14-70; higher scores indicate greater life satisfaction.
Time frame
Baseline assessment, visit #22
Effects of psilocybin on quality of life
Description: Quality of life will be assessed using a validated self-report questionnaire. Measure: * Quality of Life Questionnaire (QOL): Score range = 14-70; higher scores indicate greater life satisfaction.
Time frame
30 day post drug administration (Follow up #1), Visit #93
Effects of psilocybin on quality of life
Description: Quality of life will be assessed using a validated self-report questionnaire. Measure: * Quality of Life Questionnaire (QOL): Score range = 14-70; higher scores indicate greater life satisfaction.
Time frame
60 day post drug administration (Follow up #2), Visit #104
Effects of psilocybin on quality of life
Description: Quality of life will be assessed using a validated self-report questionnaire. Measure: * Quality of Life Questionnaire (QOL): Score range = 14-70; higher scores indicate greater life satisfaction.
Time frame
120 days post drug administration (Follow up #3), Visit #11Other outcomes
1
Effects of psilocybin on cognitive flexibility
Description: Cognitive flexibility will be assessed using a neuropsychological test that measures executive function and task-switching ability. Measure: * Trail Making Test (TMT Part B): Time to completion (seconds); shorter time indicates better executive function.
Time frame
Baseline, visit #22
Effects of psilocybin on cognitive processing speed
Description: Cognitive processing speed will be assessed using a standardized neuropsychological task. Measure: * Digit Symbol Substitution Task (DSST): Number of correct responses in 90 seconds; higher scores indicate better cognitive processing speed.
Time frame
120 days post-drug administration (Follow Up #3), Visit #11.3
Effects of psilocybin on inhibitory control
Description: Inhibitory control will be assessed using a validated cognitive task that measures response inhibition. Measure: * Stroop Color and Word Task: Reaction time (milliseconds); shorter reaction times indicate better inhibitory control.
Time frame
Baseline, visit #24
Effects of psilocybin on inhibitory control
Description: Inhibitory control will be assessed using a validated cognitive task that measures response inhibition. Measure: * Stroop Color and Word Task: Reaction time (milliseconds); shorter reaction times indicate better inhibitory control.
Time frame
120 days post-drug administration (Follow Up #3), Visit #11Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Kevin Murnane
Lead sponsor
Louisiana State University Health Sciences Center Shreveport
Sponsor institution
Source ClinicalTrials.gov