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SUBJECT'S CONSENT FORM

 

Title:

Principal Investigator: Francisco A. Moreno, M.D.

Institution: University of Arizona Health Sciences Center

Tucson, Arizona, 85724-5002

________________________________

Participant's Name / Birthdate

 

I AM BEING ASKED TO READ THE FOLLOWING MATERIAL TO ENSURE THAT I AM INFORMED OF THE NATURE OF THIS RESEARCH STUDY AND OF HOW I WILL PARTICIPATE IN IT, IF I CONSENT TO DO SO. SIGNING THIS FORM WILL INDICATE THAT I HAVE BEEN SO INFORMED AND THAT I GIVE MY CONSENT. FEDERAL REGULATIONS REQUIRE WRITTEN INFORMED CONSENT PRIOR TO PARTICIPATION IN THIS RESEARCH STUDY SO THAT I CAN KNOW THE NATURE AND RISKS OF MY PARTICIPATION AND CAN DECIDE TO PARTICIPATE OR NOT PARTICIPATE IN A FREE AND INFORMED MANNER.

 

PURPOSE

I am being invited to voluntarily participate in the above- titled research project. The purpose of this project is to study the effects of oral administration of a drug called psilocybin in people with obsessive-compulsive disorder in people who have experience using hallucinogenic drugs. Psilocybin is a naturally occurring substance that is present in many mushroom species that grow throughout the world. Psilocybin has been reported to quickly reduce obsessive compulsive disorder symptoms in a small number of people. While psilocybin is a hallucinogenic drug, it also has potent effects on a chemical system in the brain that we believe is involved in reducing the symptoms of obsessive compulsive disorder. If there is improvement in obsessive compulsive symptoms in this study, then it may lead to important new treatments for obsessive compulsive disorder. Psilocybin is not currently approved for human use and is a highly restricted drug. The doctors in this study have special permission from the Food and Drug Administration to give psilocybin to people for the purposes of this study

 

SELECTION CRITERIA

I am being invited to participate because I am between the ages of 21 and 60, have previously used hallucinogenic drugs without serious complications, and have moderate to severe obsessive-compulsive disorder and have failed to get better after at least one prior trial with medication treatment. I cannot participate if I have a history of psychosis or if there has been anyone in my immediate family with psychotic problems. I am not able to participate if I am currently depressed or have another mental or medical illness. Approximately 10 subjects will be enrolled into this study.

STANDARD TREATMENTS

I understand that this is not a treatment study, and psilocybin is not an alternative to standard OCD treatment. Standard antiobsessional treatments are readily available and they include: clomipramine, fluoxetine, fluvoxamine paroxetine, and sertraline. When these medications fail to provide improvement other pharmacological, psychotherapy, and surgery alternatives may be tried.

PROCEDURE(S)

If I agree to participate, I will receive a thorough medical and psychiatric evaluation to determine if I am a suitable subject. These evaluations will include history taking sessions(s), a physical and neurological examination, an electrocardiogram and routine laboratory studies of blood and urine. The medical and psychiatric evaluations will involve about three hours of my time. The results of these studies will be discussed with me. If I am a suitable subject, and if I decide to participate, I will be scheduled for anywhere from one and up to four test sessions. Testing includes taking different doses of psilocybin by mouth, some of which may be enough to induce a hallucinogenic/psychedelic experience, and some of which may not. The order of the doses will not be known to me or the study doctors, but will be available in case of an emergency.

Testing: Each test occurs over a 24-hour period. I can not have any solid food after midnight on the night before each test period, although I can have water, fruit juice, or soda to drink. I will arrive to the outpatient research clinic at 8:00 AM, and answer questionnaires about how I feel. This will take about 30 minutes. I will then be asked to take a dose of psilocybin by mouth. I will remain in the study room at the Hospital until 6:00 PM. During this time, I will not be allowed to sleep but can move about, eat or drink fluids at leisure, and go to the bathroom. Questionnaires regarding my thoughts and behaviors will be obtained at 1, 4, and 8 hours after taking psilocybin. I will be continuously monitored by one of the study investigators during those first 8 hours and at 6:00 PM I will be placed in a private room at the psychiatric unit of the University Medical Center, where I will spend the night. The next day, I will be escorted back to the outpatient psychiatry clinic where I will once again fill out questionnaires about how I feel and be interviewed by one of the study investigators. If I am feeling well enough to go home, I will be allowed to leave the hospital. If I am not feeling well enough, or if the doctors are concerned about me, I may be asked to stay overnight again. I will not be allowed to return home until the doctors are assured that it will be safe for me to do so.

If no adverse effects are observed, I may be asked to continue with up to three additional testing sessions two weeks apart. These will involve the same process of evaluation and staying in the hospital as described above. If subjects in this study experience improvement in obsessive-compulsive disorder symptoms in the initial tests sessions, then the following sessions will be cancelled. If any serious adverse effects occur at any time during testing, then further testing will not be performed.

I will be contacted by the investigators weekly for one month, and monthly for 6 months to monitor the effects of the drug in the long run. If in their opinion I am at high risk for complications or have complications, I will be contacted more frequently, and treated as necessary.

 

RISKS

The risks involved in this study include: 1) risks related to taking psilocybin and 2) blood drawing. 1) Psilocybin is a hallucinogenic/psychedelic drug. At the higher doses, psilocybin can cause severe distortion in all body sensations and thinking. This can include abnormal perception in all senses such as visual changes, visual hallucinations, hearing changes and auditory hallucinations, abnormal smells or bodily sensation, and an unusual mixing of sensations where for example sounds may be perceived as pictures or images or colors could be perceived as tastes. These experiences are usually accompanied by intense changes in mood states. This can include elation or euphoria, anxiety and panic feelings, or depressive feelings. Emotions can change quickly from one to another. While these experiences are described by most people as pleasant or profound, to some it may be frightening and include symptoms of panic, depression, and confusion. The symptoms listed above usually begin within the first hour after taking the psilocybin and can last for up to 12 hours, although most people find that these symptoms are gone by 6 hours after ingestion.

Psilocybin can also cause dizziness, nausea, vomiting, headaches, increased pulse and blood pressure, dilated pupils, slightly elevated temperature, raising of skin-hair, and increased reflexes. These symptoms usually can begin 20 to 30 minutes after taking the drug and can last up to 6 hours.

At times psychedelic sensations or memories of these sensations may be re-experienced in the future and this has been called "flashbacks". It is not known how often this really occurs. Some studies have reported that it does not really happen and other studies suggest that some people do have these experiences. Other complications such as prolonged psychosis, suicide, or homicide have been attributed to use of hallucinogenic drugs. It is unclear to what extent these effects can be caused by hallucinogenic drugs. There are no large, well-controlled studies of psilocybin.

If I have any adverse reactions that lead the doctors involved with this study to be concerned about my safety, they may have to detain me in the hospital until they feel I am safe to go home. If I have a reaction such that I become very upset, it is possible that the study doctors may have to give me medication to help me calm down.

2) The risk of blood drawing is minimal when done by a professional. I might develop a bruise at the site of blood drawing but this will go away in two to three days.

 

BENEFITS

There are no benefits to me of participation in this study.

 

CONFIDENTIALITY

Care will be taken to preserve confidentiality of all information obtained from this study. Furthermore, my identity will not be revealed in any publication of study results. However, representatives of the US. Food and Drug Administration (FDA) or the institutional review Board of the University of Arizona may review my medical records. By signing this consent form I am consenting to such reviews.

 

PARTICIPATION COSTS AND SUBJECT COMPENSATION

The study medications, visits to the doctor, hospital costs, and all tests and examinations will be provided to me at no cost. For my participation, I will not receive additional compensation. If treatment is required due to adverse effects relating to my having participated in this study, this will be provided by the study investigators at no cost to me.

 

LIABILITY

I understand that side effects or harm are possible in any research program despite the use of high standards of care and could occur through no fault of mine or the investigator involved. Known side effects have been described in this consent form. However, unforeseeable harm may also occur and require care. I understand that money for research-related side effects or harm, or for wages or time lost, is not available. I do not give up any of my legal rights by signing this form. Necessary emergency medical care will be provided without cost. I can obtain further information from Francisco A. Moreno, M.D. at 626-6509. If I have questions concerning my rights as a research subject, I may call the Human Subjects Committee office at 626-6721. Additional information/questions concerning liability (other than covered above) must be discussed with the Principal Investigator, sponsor, or the institution.

 

AUTHORIZATION

BEFORE GIVING MY CONSENT BY SIGNING THIS FORM, THE METHODS, INCONVENIENCES, RISKS, AND BENEFITS HAVE BEEN EXPLAINED TO ME AND MY QUESTIONS HAVE BEEN ANSWERED. I UNDERSTAND THAT I MAY ASK QUESTIONS AT ANY TIME AND THAT I AM FREE TO WITHDRAW FROM THE PROJECT AT ANY TIME WITHOUT CAUSING BAD FEELINGS OR AFFECTING MY MEDICAL CARE. MY PARTICIPATION IN THIS PROJECT MAY BE ENDED BY THE INVESTIGATOR OR BY THE SPONSOR FOR REASONS THAT WOULD BE EXPLAINED. NEW INFORMATION DEVELOPED DURING THE COURSE OF THIS STUDY WHICH MAY AFFECT MY WILLINGNESS TO CONTINUE IN THIS RESEARCH PROJECT WILL BE GIVEN TO ME AS IT BECOMES AVAILABLE. I UNDERSTAND THAT THIS CONSENT FORM WILL BE FILED IN AN AREA DESIGNATED BY THE HUMAN SUBJECTS COMMITTEE WITH ACCESS RESTRICTED TO THE INVESTIGATORS, F. MORENO, M.D., P. DELGADO, M.D., OR AN AUTHORIZED REPRESENTATIVE OF THE PSYCHIATRY DEPARTMENT. I UNDERSTAND THAT I DO NOT GIVE UP ANY OF MY LEGAL RIGHTS BY SIGNING THIS FORM. A COPY OF THIS SIGNED CONSENT FORM WILL BE GIVEN TO ME.

 

Subject's Signature / Date

 

Witness / Date

 

INVESTIGATOR'S AFFIDAVIT

I have carefully explained to the subject the nature of the above project. I hereby certify that to the best of my knowledge the person who is signing this consent form understands clearly the nature, demands, benefits, and risks involved in his/her participation and his/her signature is legally valid. A medical problem or language or educational barrier has not precluded this understanding.

Signature of Investigator / Date


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