Study Information & Informed Consent
The following is a short summary of this study to help you decide whether or not to be a part of this study. It includes a form to provide your informed consent, which is required for participation.
Exploring the Oneirogenic Experience in Ibogaine Therapy
Jonathan Dickinson and Nicholas Boeving, Ph.D.
December 6, 2020
Purpose of the Research
We are inviting you to take part in a research study as a participant. This research study will attempt to expand our understanding of the oneirogenic (dream-generating) experience when people take ibogaine, as well as a number of factors that might influence this experience.
This is an observational study that will involve a total of 20 participants. Taking part will not change any of the practical aspects of the treatment that you are undergoing voluntarily. For some people, the ibogaine experience can be quite rich, complex, symbolic, personal, and insightful. For others, it might be something milder, or maybe difficult to remember at all. No matter what type of experience you have, your experience will be valuable in helping to understand and explain the nature of these experiences to others.
Explanation of Procedures
Once you complete this Informed Consent form you will provisionally accepted as a participant and provided with a 6-digit Participant ID code. You will use this Participant ID code to complete a Study Intake Form, which will ask you some basic personal and medical information, including information about your drug use history. You will only be fully accepted into the study after your Study Intake Form has been reviewed.
If you enter the study you will be asked to:
- Complete a series of intake questionnaires that take about 1 hour to complete before you arrive at the clinic;
- Undergo an extra 1 hour of intake procedures with a nurse when you arrive at the clinic;
- Be asked a series of brief questionnaires about withdrawal symptoms (2 minutes each) 2 times per day while at the clinic;
- Complete a series of questionnaires after your ibogaine experience, which will take about 30 minutes to complete;
- Be interviewed by a research for 30 minutes to 1 hour within 72 hours of your experience;
- Be contacted 1 month later to complete a final set of questionnaires that take about 1 hour to complete;
- Be interviewed by a different researcher for 30 minutes to 1 hour about 1 month after leaving the clinic.
For the initial intake and follow-up questionnaires you will be contacted by email. Failing to complete the questionnaires at any stage of this procedure may disqualify you from inclusion in the study.
You may qualify for the study if:
- You undergo ibogaine treatment at the Experience Ibogaine Treatment Center;
- Are at least 18 years of age;
- You are fluent in English, both spoken and written;
- You sign the informed consent form attached here;
- You have access to a personal email account and a device with which you can access the internet.
You will not qualify for the study if any of the following are true:
- You are withdrawn for any reason after intake at the Experience Ibogaine Treatment Center;
- You are younger than 18 years of age;
- You are not fluent in English, either spoken or written;
- You have any medical or psychiatric condition for which the investigators deem you unable to participate in the study.
Risks & Discomforts
You will be informed about the risks of undergoing ibogaine treatment by the clinic where you will undergo the treatment. This research is conducted independently. The investigators have determined that the risks of participating in this research are minimal. However, during the course of completing the questionnaire and the interviews involved you may be asked to discuss topics that arouse some discomfort for you, such as personally challenging situations, illegal behavior.
You may withdrawal from the study at any time. The clinic employs therapeutic support, and if needed you are encouraged to reach out for additional therapeutic support. Additional support will not be provided on behalf of the research and is an independent activity. Below are a list of mental health professionals who have experience with ibogaine.
An additional risk is that personally identifying information could be compromised – that is, that people outside the study might get hold of confidential study information. We will do everything that we can to minimize this risk, as described in more detail later in this form.
There are no anticipated benefits to you or others from you taking part in this research. You will not be compensated for your participation.
However, information collected through this research study may help the investigators better understand ibogaine’s effects when administered in a therapeutic context, which could result in improvements to treatments both at the study site, and more broadly.
Once you complete this Informed Consent Form you will be provided with a 6-digit Participant ID that will be used when completing any future study materials. This will be to protect your identity in case of an information breach while the study is being conducted. All of the information collected throughout this study will be kept in password protected and, wherever possible, encrypted files. Once you complete the one-month follow-up questionnaires and the final interview, the database table that links your name and contact information to your Participant ID code will be deleted.
Information obtained about you for this study will be kept confidential to the extent allowed by law. In order to prevent the mandated reporting of your sensitive information to law enforcement or any other state agency in the United States this study has been granted a Certificate of Confidentiality from the US National Institute on Health (#CC-OD-21-1336).
However, research information that identifies you may be shared with the Institutional Review Board (IRB) and others who are responsible for ensuring compliance with laws and regulations related to research, including people on behalf of Terragnosis Inc. and the Office for Human Research Protections (OHRPP). The information from the research may be published, including verbatim transcripts of the interviews conducted by either of the researchers. However any personally identifying information in statements that you make will be redacted before publication, and before these transcripts are backed up for long-term storage. Monitors, auditors, statistical analysts, and the Institutional Review Board (IRB) will be granted direct access to the questionnaire data and interview transcripts without violating confidentiality.
Voluntary Participation & Withdrawal
Whether or not you take part in this study is your choice. There will be no penalty if you decide not to be in the study. If you decide not to be in the study, you will not lose any benefits you are otherwise owed. You are free to withdraw from this research study at any time. Your choice to leave the study will not affect your relationship with the Experience Ibogaine Treatment Center.
You may be removed from the study without your consent if the sponsor ends the study or if you are not completing the study requirements.
If you have questions, concerns, or complaints, or think the research has caused you any distress or injury, please talk to Jonathan Dickinson. He will be glad to answer any of your questions. Jonathan Dickinson’s phone number is +1 (347) 515-1507 and his email is firstname.lastname@example.org.
You are not waiving any of your legal rights by signing this informed consent form.
Future Usage of this Data
The goals of this study will be to publish any findings in scientific journals, or to present this information at conferences, or in other media. Non-personally identifying information that you provide through the questionnaires and interviews may be used in future research efforts.
By signing below you agree that you understand the above. You will be asked to confirm that you understand the following:
- That there is no therapeutic benefit anticipated from participating in this research study.
- That there will be no remuneration for participating in this research study.
- That the quality of care you will receive from the clinic will not be impacted by participating, by refusing to participate, or by withdrawing from this research study if you choose to do so.
Once you sign below you will be provisionally enrolled. A 6-digit Participant ID will be prepared manually and sent to you within the next few days, and you will be asked to complete a Study Intake Form. Final determination of your acceptance into the study will depend on your responses to the Study Intake Form.