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Ayahuasca Assisted Psychotherapy for Grief

NCT06150859 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2023-12-11

No results posted yet for this study

Summary

The aim of this study is to compare the effectiveness of an ayahuasca-assisted constructivist therapy with constructivist therapy and no treatment to decrease the severity of grief. A secondary purpose is to assess the effectiveness to prevent Persistent Complex Bereavement Disorder and Prolonged Grief Disorder, and to assess potential changes in avoidance, meaning-making and self-clarity. Subjective effects and Acceptance promoting effects of psychedelic drug are assessed after ayahuasca administration. A non-randomized controlled trial is proposed with three arms involving an experimental group (ayahuasca in concert with psychotherapy) and two control groups (psychotherapy and no treatment) with pretest, posttest and 3 months follow-up.

Conditions

  • Bereavement

Interventions

DRUG

Ayahausca-Assisted psychotherapy

Drug: Two ayahuasca administrations (0.75 mg/kg DMT), after 3rd and 6th therapeutic session. Ayahuasca is a psychoactive mixture of plants which contains DMT as an active principle. Constructivist Psychotherapy will be delivered over 9 online psychotherapeutic sessions.

BEHAVIORAL

Constructivist Psychotherapy

Constructivist Psychotherapy will be delivered over 9 online psychotherapeutic sessions

OTHER

No treatment

No treatment during the control period

Sponsors & Collaborators

  • Beckley Med Foundation

    lead OTHER

Principal Investigators

  • Magi Farré · Hospital German Trials I Pujol

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-15
Primary Completion
2024-04-15
Completion
2024-06-15

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06150859 on ClinicalTrials.gov