Psilocybin-assisted Group Therapy for Demoralization in Long-term AIDS Survivors

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-05

Study Completion Date

2019-12-31

Brief Summary

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The purpose of this study is to determine whether psilocybin-assisted group psychotherapy is a safe and feasible treatment for demoralization in long-term AIDS survivors (LTAS).

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Detailed Description

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This study is an open-label mixed-methods pilot study of an individual oral psilocybin drug session combined with ten sessions of an evidence-based, manualized brief group psychotherapy for existential distress in palliative care patients.

Conditions

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Distress Depression Grief

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group therapy plus psilocybin

Modified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting.

Group Type EXPERIMENTAL

Psilocybin

Intervention Type DRUG

One individual oral psilocybin treatment session

Modified brief Supportive Expressive Group Therapy

Intervention Type BEHAVIORAL

Ten sessions of twice-weekly manualized group therapy

Interventions

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Psilocybin

One individual oral psilocybin treatment session

Intervention Type DRUG

Modified brief Supportive Expressive Group Therapy

Ten sessions of twice-weekly manualized group therapy

Intervention Type BEHAVIORAL

Other Intervention Names

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4-phosphoryloxy-N,N-dimethyltryptamine Indocybin

Eligibility Criteria

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Inclusion Criteria

* Older individuals who are long-term AIDS survivors and suffer from moderate-to-severe demoralization.

Exclusion Criteria

* A physical, neurological or cognitive condition that makes participating in the study unsafe or unfeasible.
* Regular psychotropic medication use.
* Personal or family history of serious mental illness.
* Severe depression requiring immediate standard-of-care treatment.
* Exclusion by the clinical judgment of the study investigators.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No