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Psilocybin Assisted Psychotherapy for Treatment Resistant Depression and Co-occurring Substance Use Disorder

ConditionsTreatment Resistant DepressionSubstance Use Disorders
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorIndiana University

About this trial

The goal of this clinical trial is to learn if a single dose of psilocybin (5mg Vs 10mg Vs 25mg) alongside psychotherapy is safe and can help treat treatment resistant depression (TRD) with co-occurring substance use disorder (SUD) in veterans and first responders. We seek to answer:

* Whether 5mgs, 10mgs and 25mgs of psilocybin are safe in individuals with co-occurring TRD and SUD * Whether psilocybin assisted psychotherapy will reduce substance use severity and depression symptoms * What neurobiological processes are associated with the effects of psilocybin assisted psychotherapy.

The researchers will compare the effects of a single dose of psilocybin (either 5mgs or 10mgs or 25mg) alongside psychotherapy on substance use severity and depression symptoms over six weeks in veterans and first responders with TRD and co-occurring SUD.

In this 14-week study, participants will:

* Visit the clinic for two intake sessions * Complete seven psychotherapy sessions. This will include three sessions before psilocybin administration, an 8 to 10 hour dosing session, and three sessions following psilocybin administration * Complete short, repeated daily assessments for six weeks, in total, before and after psilocybin administration * Complete two brain scans before and after psilocybin administration

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Psilocybin

    Drug

    Participants will be randomly administered a single dose of either 5mg or 10mg or 25mg psilocybin

Treatment groups

50 Participants
are divided into 3 treatment groups
Group A: Psilocybin Dose - LowExperimental treatment 1 intervention
Group B: Psilocybin Dose - ModerateExperimental treatment 1 intervention
Group C: Psilocybin Dose - HighExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

percentage number of participants with Adverse Events (AEs)

AEs that occur after administration of the single psilocybin dose or worsen from a pre-treatment state.

Time frame
Weekly for 12-weeks and once during a 60-day follow-up
2

Change in % number of positive urines

urine toxicology screens for alcohol and substance use will be collected

Time frame
Weekly for 12-weeks
3

Change in % number of days spent using substances

Self reports of alcohol and substance use, using the timeline followback (TLFB) and brief ecological momentary assessment (EMA) items

Time frame
Weekly for 12-weeks TLFB and 5 times per day in weeks 1, 2, 5, 6, 10 & 11 (brief items)
4

Change in severity of depression symptoms

Self reports of depressive symptomatology, using the Quick Inventory of Depression Symptoms-Self-Report (QIDS-SR) and brief EMA items using the Positive and Negative Affect Schedule (PANAS)

Time frame
Weekly for 12-weeks QIDS and 5 times per day in weeks 1, 2, 5, 6, 10 & 11 for PANAS

Secondary outcomes

1

Change in amount of substance consumed per occasion

Self reports of alcohol and substance use, using the TLFB and brief EMA items

Time frame
Weekly for 12-weeks TLFB and 5 times per day in weeks 1, 2, 5, 6, 10 & 11 (brief items)
2

Change in number of binge episodes

Self reports of alcohol and substance use, using the TLFB and brief EMA items

Time frame
Weekly for 12-weeks TLFB and 5 times per day in weeks 1, 2, 5, 6, 10 & 11 (brief items)
3

Change in craving

Various standardized craving scales will be used to collect self-report craving data in addition to brief EMA items

Time frame
Weekly for 12-weeks (various dependent upon participants substance of choice) and 5 times per day in weeks 1, 2, 5, 6, 10 & 11 (brief items)
4

Change in anxiety

The State-Trait Anxiety Inventory (STAI) will be used to collect self-report anxiety data in addition to brief momentary assessment items

Time frame
Weekly for 12-weeks (STAI) and 5 times per day in weeks 1, 2, 5, 6, 10 & 11 (brief items)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indiana University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: