Questionnaire to assess the acute subjective effects of ibogaine
Study code: UAM-ICEERS-IBO-02-2015.

Sponsor: ICEERS (International Center for Ethnobotanical Education, Research & Service), Barcelona, Spain.

Research team:

Principal investigator:

José Carlos Bouso
ICEERS, Barcelona, Spain.
Universitat Rovira i Virgili (URV), Medical Anthropology Research Center (MARC), Tarragona, Spain.
Phone +34688 913 471 / +34 931 882 099
Email: jcbouso@iceers.org

Co-Principal Investigator

Miguel Ángel Alcázar-Córcoles
Department of Biological & Health Psychology, School of Psychology, Madrid Autonomous University, 28049 Madrid, Spain.

Researchers:

Jonathan Dickinson
ICEERS, Barcelona, Spain.
Email: hub.jondickinson@gmail.com

Genís Ona
ICEERS, Barcelona, Spain.
Universitat Rovira i Virgili (URV), Medical Anthropology Research Center (MARC), Tarragona, Spain.
Email: genisona@iceers.org

Maja Kohek
ICEERS, Barcelona, Spain.

Rafael G. dos Santos
ICEERS, Barcelona, Spain.
Department of Neuroscience and Behavior, Ribeirão Preto Medical School, University of São Paulo, SP, Brazil.
National Institute for Translational Medicine (INCT-TM), CNPq, Brazil.

Jaime. E.C. Hallak
Department of Neuroscience and Behavior, Ribeirão Preto Medical School, University of São Paulo, SP, Brazil.
National Institute for Translational Medicine (INCT-TM), CNPq, Brazil.

This study was approved by the Research Ethics Committee of the Universidad Autónoma de Madrid (Autonomous University of Madrid), Spain.

Study objective

The objective of this study is to construct a questionnaire about the effects of ibogaine, which will allow us to better understand them.

Voluntary participation

You are completely free to choose whether to participate in the study or not and to withdraw from it if desired at any time.

Number of participants

This study calls for the participation of a sample of 500 people, who have been taken ibogaine (ibogaine-HCl or ibogaine extracts) at some time point in their life and who are willing to be interviewed in the English language about the subjective psychological, bodily and spiritual experiences they had the last time they ingested the drug.



Study procedures

In this study you will have to fill a questionnaire about the experience you had under the acute influence of ibogaine, the last (most recent) time you used ibogaine orally. It will take approximately 20 minutes.

Your answers to the questionnaire are strictly confidential and will be anonymous, so that it is impossible to match them with your person. You are free to ask questions at any time. Before, during and after completing the questionnaire.

Please try to answer the items as precise and honest as possible. After answering the questions, you have the opportunity to add anything you like to your experience or anything you think you forgot or you think which might be important.


Expected benefits and risks

Any direct benefit received from participation in the study should not be expected. Your participation in this study will allow us to better understand the possible short- and long-term benefits of ibogaine treatment and thus will help us further the field of ibogaine research.

The completion of the questionnaire does not pose any risk to your bodily health.


Confidentiality

The communication and cessation of personal information of all subjects will be performed according to the Data Protection Law of European Union 2016/679 and the Organic Law of Data Protection and Digital Rights 3/2018.
You may at any time exercise your rights of access, rectification, cancellation and opposition to the attending investigator in this study, who will inform the sponsor.
Further, the study results may be shared with the scientific community through conferences and publications without your identity being disclosed at any time.

Questions / Information:

If you wish to ask any questions or clarify any issue related to the study, or if you need help with any health problems related to this study, please do not hesitate to contact the researchers.


Informed Consent

By introducing below my name and signature I confirm that:

- I Have read the information sheet that has been given to me.
- I Have had the opportunity to ask questions about the study.
- I Have received satisfactory answers.
- I Have received sufficient information regarding the study.
- I Have talked to the researcher (JD)
- I understand that participation is voluntary.
- I understand that I can withdraw from the study:

• Whenever I wish to.

• Without needing to give an explanation.

• Without it affecting my medical care.

- I have also been informed in a clear, accurate and sufficient manner about the following points that affect the personal information contained in this consent form and the files or records that will be opened for the research:

This information will be treated and maintained with respect for my privacy and the current data protection legislation of Spain and European Union.

Regarding this personal information, I have the rights of access, rectification, cancellation and opposition, which may be exercised by making a request to the researcher in charge, through the contact address indicated in this document.

This information may not be transferred or used without my express consent and I do not grant this by signing this form.


I declare that I have read and understand the contents of this document, I understand the commitments that I am assuming and I expressly accept them. I, therefore, sign this informed consent voluntarily to EXPRESS MY DESIRE TO PARTICIPATE IN THIS RESEARCH STUDY ON THE LONG-TERM PSYCHOLOGICAL EFFECTS OF IBOGAINE TREATMENT, until I decide otherwise. By signing this consent form I do not waive any of my rights. I will receive a copy of this consent form to keep and reference in the future.


The promoter and the associated researchers thank you very much for participating!
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