DistressPhase 1NCT02950467
Psilocybin-assisted Group Therapy for Demoralization in Long-term AIDS Survivors
A Phase 1 study testing Psilocybin and Modified brief Supportive Expressive Group Therapy in people with Distress and Depression, run by Joshua Woolley at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Distress, Depression, Grief
- What is being tested?
- Psilocybin and Modified brief Supportive Expressive Group Therapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2018to 31 Dec 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older individuals who are long-term AIDS survivors and suffer from moderate-to-severe demoralization.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
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).
Read the detailed description
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
- Distress, Depression, Grief
- Being tested
- Psilocybin, Modified brief Supportive Expressive Group Therapy
- Keywords
- HIV/AIDS, Demoralization, Psilocybin, Group therapy
- Medical subject headings
- Depression, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
Also called 4-phosphoryloxy-N,N-dimethyltryptamine, Indocybin
One individual oral psilocybin treatment session
Modified brief Supportive Expressive Group TherapyBehavioural
Ten sessions of twice-weekly manualized group therapy
| Study group | Role | What they receive |
|---|---|---|
| Group therapy plus psilocybin | Experimental | Modified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting. Receives: Drug: Psilocybin; Behavioral: Modified brief Supportive Expressive Group Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced Treatment-related Adverse Events as Assessed by NIH Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0
Full details of adverse event data are in the Adverse Events module of this ClinicalTrials.gov entry.
Adverse events were assessed at every study visit by patient interview. During medication visits, adverse events were also assess by vitals sign monitoring, patient self-report, and adverse events observed by clinicians.
Measured: Enrollment to 3-month follow up, about 5 months
Subject Recruitment and Retention
Two therapy groups of at least 4 subjects each will complete the study
Measured: Duration of study, about 24 months
Secondary outcomes (7)
Change From Baseline in Demoralization Scale-II at End-of-treatment
Demoralization self-report measure. Minimum = 0. Maximum = 32. Higher scores means a worse outcome.
Measured: Baseline and end-of-treatment (7 weeks duration)
Change From Baseline in Demoralization Scale-II at 3-month Follow-up
Demoralization self-report measure. Minimum = 0. Maximum = 32. Higher scores mean a worse outcome.
Measured: Baseline and 3-month follow-up
Change From Baseline in Inventory of Complicated Grief-Revised at End-of-treatment
Complicated Grief self-report measure. Minimum = 0, Maximum = 76. Higher scores mean worse outcome.
Measured: Baseline and end-of-treatment (7 weeks duration)
Change From Baseline in Inventory of Complicated Grief at 3-month Follow-up
Complicated Grief self-report measure. Minimum = 0, Maximum = 76. Higher scores mean worse outcome.
Measured: Baseline and 3-month follow-up
Change From Baseline in Center for Epidemiologic Studies Depression Scale-Revised at End-of-treatment
Depression self-report measure. Minimum = 0. Maximum = 60. Higher scores mean a worse outcome.
Measured: Baseline and end-of-treatment (7 weeks duration)
Change From Baseline in Center for Epidemiologic Studies Depression Scale-Revised at 3-month Follow-up
Depression self-report measure. Minimum = 0. Maximum = 60. Higher scores mean a worse outcome.
Measured: Baseline and 3-month follow-up
Change in Average Score on Subscales of Group Questionnaire Pre-drug vs Post-drug
The Group Questionnaire is a self-report measure with three sub-scales that measure Positive Bonding, Positive Working and Negative Relationship dimensions of the relationships at 3 levels: between group members, between group members and group therapists, and between group members and the group as a whole. Each subscale score is calculated by summation of the ratings across all three levels for each subscale. Positive Bonding scores range from 13 to 91 with higher scores indicating a better outcome. Positive Working scores range 8 to 56 with higher scores indicating a better outcome. Negative Relationship scores range 9 to 63 with higher scores indicating worse outcomes.
Measured: Mean scores averaged over 2 weeks pre-medication compared to 3 weeks post-medication.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study start5 Jan 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joshua Woolley
- Sponsor type
- University, hospital or other
- Collaborators
- Heffter Research Institute, RiverStyx Foundation, Usona Institute, Stupski Foundation
- Responsible party
- Sponsor-investigator, Joshua Woolley, University of California, San Francisco
- Investigators
- Joshua Woolley, MD,PhD, Principal investigator, University of California, San FranciscoBrian Anderson, MD,MSc, Study director, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02950467
- Sponsor's protocol ID
- 15-17825
- Status last verified
- Dec 2020
- First submitted
- 26 Oct 2016
- Last updated
- 7 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anderson BT, Danforth A, Daroff PR, Stauffer C, Ekman E, Agin-Liebes G, Trope A, Boden MT, Dilley PJ, Mitchell J, Woolley J. Psilocybin-assisted group therapy for demoralized older long-term AIDS survivor men: An open-label safety and feasibility pilot study. EClinicalMedicine. 2020 Sep 24;27:100538. doi: 10.1016/j.eclinm.2020.100538. eCollection 2020 Oct.
PubMed 33150319
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psilocybin-assisted Group Therapy for Demoralization in Long-term AIDS Survivors
- ClinicalTrials.gov ID
- NCT02950467
- Acronym / sponsor ID
- 15-17825
- Conditions
- Distress, Depression, Grief
- Keywords
- HIV/AIDS, Demoralization, Psilocybin, Group therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Joshua WoolleyUniversity, hospital or other
- Collaborators
- Heffter Research Institute, RiverStyx Foundation, Usona Institute, Stupski Foundation
- Study start
- 5 Jan 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 1 Nov 2016 (estimated)
- Results
- Posted 7 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group therapy plus psilocybin | Experimental | Drug: Psilocybin, Behavioral: Modified brief Supportive Expressive Group TherapyModified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Older individuals who are long-term AIDS survivors and suffer from moderate-to-severe demoralization.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsilocybinAlso: 4-phosphoryloxy-N,N-dimethyltryptamine, IndocybinOne individual oral psilocybin treatment session | Drug | Group therapy plus psilocybin |
| Modified brief Supportive Expressive Group TherapyTen sessions of twice-weekly manualized group therapy | Behavioural | Group therapy plus psilocybin |
Primary outcome
Number of Participants Who Experienced Treatment-related Adverse Events as Assessed by NIH Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0
Time frame: Enrollment to 3-month follow up, about 5 months
Full details of adverse event data are in the Adverse Events module of this ClinicalTrials.gov entry. Adverse events were assessed at every study visit by patient interview. During medication visits, adverse events were also assess by vitals sign monitoring, patient self-report, and adverse events observed by clinicians.
Subject Recruitment and Retention
Time frame: Duration of study, about 24 months
Two therapy groups of at least 4 subjects each will complete the study
7 secondary outcomes
Change From Baseline in Demoralization Scale-II at End-of-treatment
Time frame: Baseline and end-of-treatment (7 weeks duration)
Change From Baseline in Demoralization Scale-II at 3-month Follow-up
Time frame: Baseline and 3-month follow-up
Change From Baseline in Inventory of Complicated Grief-Revised at End-of-treatment
Time frame: Baseline and end-of-treatment (7 weeks duration)
Change From Baseline in Inventory of Complicated Grief at 3-month Follow-up
Time frame: Baseline and 3-month follow-up
Change From Baseline in Center for Epidemiologic Studies Depression Scale-Revised at End-of-treatment
Time frame: Baseline and end-of-treatment (7 weeks duration)
Change From Baseline in Center for Epidemiologic Studies Depression Scale-Revised at 3-month Follow-up
Time frame: Baseline and 3-month follow-up
Change in Average Score on Subscales of Group Questionnaire Pre-drug vs Post-drug
Time frame: Mean scores averaged over 2 weeks pre-medication compared to 3 weeks post-medication.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33150319Anderson BT, Danforth A, Daroff PR, Stauffer C, Ekman E, Agin-Liebes G, Trope A, Boden MT, Dilley PJ, Mitchell J, Woolley J. Psilocybin-assisted group therapy for demoralized older long-term AIDS survivor men: An open-label safety and feasibility pilot study. EClinicalMedicine. 2020 Sep 24;27:100538. doi: 10.1016/j.eclinm.2020.100538. eCollection 2020 Oct.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua Woolley, MD,PhD principal investigator
University of California, San Francisco
Brian Anderson, MD,MSc study director
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Psilocybin and Modified brief Supportive Expressive Group Therapy in people with Distress and Depression, run by Joshua Woolley at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experienced Treatment-related Adverse Events as Assessed by NIH Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0 (time frame: Enrollment to 3-month follow up, about 5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02950467, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2021.