Announcement

**Cassander** · March 13, 2014, 08:23 AM

Baclofen trial by the University of Amsterdam

Thanks, X.

**Xadrian** · March 13, 2014, 09:30 AM

Baclofen trial by the University of Amsterdam

I just received the information letter.

It's a lot of text. The original was in Dutch. I only got it through the Google Translator and did not correct any grammatic mistakes.

If anyone would like to have a copy of the Dutch information letter (PFD), please send me a PM.

The Google translation reads as following:

"
Academic Medical Center, University of Amsterdam

Newsletter interested for the study: " The effect of baclofen in alcohol addiction - Who does it ?"

Amsterdam , February 2013
Dear Sir / Madam ,

First I want to thank you for participating in the study " The effect of baclofen in alcohol addiction ." For your consideration The study is a collaboration between the University of Amsterdam , AMC and some rehab. The study is designed to bring about medication used in the treatment of alcohol addiction . Know more Through this research we hope to eventually get involved in what factors in the effect of medication with alcohol addiction so that effective treatments can be developed. Understanding Participation in the survey is voluntary . You can participate in this study if you have an alcohol addiction .
In order to assess whether you want to join or not, is good information from our side and careful consideration on your part . Hence you receive this newsletter . In this letter you will find further information about the research project . Furthermore, we advise you to also "General Information Brochure Subjects Medical research ' to read . There is a lot of general information on medical research in . Should you require further assistance , please contact the researcher ( contact details below ) . If you have any further questions , understood what the research entails , and want to participate in the survey , you will be asked to fill in the attached consent form and sign it.
Thanks again for your interest in this study . Especially do not hesitate to contact us if you have any further questions.
Sincerely ,
Esther Beraha
University of Amsterdam
Developmental Psychology
Tel . 0342-427060 or 020-5256871
Email: EMBerahaMenahem@uva.nl or DTHAdejong@uva.nl 2

Information about the research project ' The effect of high-dose baclofen in alcohol addiction - Who does it ? "
Where is the research for ?
Problems with alcohol can greatly affect a person's life and therefore are good treatments of interest. In addition to the available therapies, drugs are used more and more often to treat alcohol addiction. This research focuses on the effectiveness of a new drug used in alcohol addiction : Baclofen . Baclofen is already used to treat spasms , but recently also for the treatment of alcohol addiction . Since baclofen is used only recently for the treatment of alcohol addiction , there is little research into the effectiveness of baclofen done . There is especially little knowledge about which patients are most likely to benefit from baclofen . The aim of the study is to obtain information on the impact and effects of baclofen knowledge. This will help in the future to help people. Better with an alcohol addiction
How is the research carried out and how long does it take?
The study lasts 18 weeks and consists of three test sessions . The first two test sessions take place during your stay in the clinic or during your daily program . The third test session will take place after 16 weeks before or after an aftercare group as usual as part of your treatment . The first meeting will take place before the beginning of the treatment program and the first dose of baclofen . During the first appointment you will be asked to fill in , which we would like to know about your alcohol use and personality traits . More of a number of questionnaires The questionnaires that are widely used in practice . Furthermore, you will be prompted to do so. Three computer tasks You do have . No computer The first test will take about 60 to 90 minutes max .
The second test session will take place two days before leaving the clinic. During the second appointment , the same questionnaires and computer tests done and during the first appointment . The third meeting will be 12 weeks after leaving place prior to or after an aftercare group the clinic. You will be asked again to fill in the questionnaires and to perform. Computing tasks This will be a time again about 60 - last 90 minutes .
Furthermore, you have a short appointment with a doctor or psychiatrist . During the first 6 weeks every week For these appointments fill some questionnaires. It will then decide if your dose is changed. During the first six weeks you will be seen . Weekly by a physician From week 7 to week 18 , you have one every two weeks, an appointment with a psychologist or nurse . These appointments will take place before or after an aftercare group . For these appointments fill some questionnaires about your alcohol use and possible side effects . During the appointments alcohol concentration is determined by your breath your blood delivers your medication that you may have about new medications and is given to you . During the study period 10 such appointments will be scheduled . These appointments will take about 10 minutes each time . So you need extra time to plan for the after care visit. 3

Furthermore, you will be asked to keep track of how many pills every day you are taking and how much alcohol you may drink . For this you get a booklet , which may be incorrect.
In total you spend on this research so up to 8 hours .
Moreover, after 6 months call are recorded and you will be asked about your alcohol use, health and wellness questions.
Your GP will be informed about your participation in this study .
When will the first test session instead ?
It is possible that during your stay in the clinic or day medications are prescribed . The first days To minimize any effect of this medication on computer tests and questionnaires , the first testing session only done when you stop using this medication .
What the medication is administered ?
You will get over 18 weeks of baclofen . However, there is also the chance that you fake pills , get so-called placebo . During the first six weeks, the dose is increased and adjusted so you get the best working for you dose. There will care be taken that no overdose occurs. The next three months go by with this dosage . From week 16, the medication gradually phased out . The medication is administered orally three times per day in the form of tablets. If you received placebo during the study , you can still get at the end of the study treatment with baclofen .
Can I still use my own medication
Or you can use your own medication is presented for the beginning of the study with a doctor at the clinic . Therefore, you are also asked to indicate what medication you are currently using .
What is the tax for me as a subject ?
The first day of the study will take place during your stay in the clinic . The second appointment will take two days before leaving again in the clinic instead . , The third meeting in week 18 place before or after an aftercare visit. Each test day, takes approximately 60 to 90 minutes. In addition, three short appointments during your stay at the clinic and seven short appointments scheduled before or after an aftercare visit , in connection with the provision of study medication . Each appointment takes about 10 minutes . Call will be recorded with you , after 6 months, this interview will take about 10 minutes . Furthermore you get prescribed baclofen or placebo for 18 weeks.
At the beginning and the end of the study, two times about 30 ml of blood will be taken. The blood samples are used to determine which will serve . Alcohol as an objective measure of biological markers Moreover, prior to screening and decreased during the therapy sessions of aftercare bladder tests , your breath alcohol concentration to be determined . 4

Furthermore, we would like to carry out a genetic analysis ( DNA testing ) . This is done in order to determine whether people with certain genes have more benefit from a treatment with baclofen . Therefore we would ask for it to give . At the beginning of the study once saliva Here is a little saliva samples using a cotton swab . This decrease does not hurt and does not take risks with it . Your body material will be retained . 20 years after completion of the study in encrypted form If you decide you would like subjects to withdraw from the study, please ask to set aside the decreased genetic material. You can do this by contacting one of the persons listed below under contacts. Contact
Participation in the study or dangerous has disadvantages for health?
The drug baclofen is registered in the Netherlands. Like all medicines can have baclofen side effects, although not everybody gets it. 10 %) voorkomende bijwerkingen van baclofen zijn: Sufheid, slaperigheid en misselijkheid."Very common ( > 10 % ). Baclofen side effects include: Drowsiness , somnolence and nausea . These side effects , especially in the beginning of the use and usually disappear after a few days. Common ( 1-10 % ) side effects of baclofen are : Decrease cardiac output , light -headedness , dizziness , headache , disturbance of balance and movement coordination , tremors , shaking wiggle eyes , blurred vision , visual disturbances , impaired breathing , low blood pressure , vomiting , constipation , diarrhea , dry mouth , increased sweating , rash , excessive urination , unwanted blaasontlediging , difficulty urinating, fatigue , confusion , euphoria , depression , hallucinations , muscle pain or weakness . Rare ( 0:01 -0.1 % ) side effects of baclofen are : Disturbance in the sense perception, speech disorder , difficulty in urinating , erectile dysfunction , stomach disorders , taste impairment, and liver function . Very rare ( r of pills that are prescribed .
What does voluntary participation in ?
If you no longer wish to participate in the investigation, then it has no influence on your treatment at your clinic . You 're completely free to participate in this study. Before participating in the study , you will be asked to sign a consent form. This form shall include provisions:
 your right to information about the investigation;
 the commitment that all information will be treated confidentially and are coded for the analysis process ;
 the voluntariness of your participation .

Also, once you take part in the survey , you are always free to refrain from further participation , even if you have declared their willingness to participate . Written once However, for us it would be a great advantage if you go through the whole investigation , otherwise no results can be obtained .
In addition , the researcher has the right , without your permission , to stop it. Study or your participation in the study at any time
How are the survey recorded?
The survey data are fully encrypted and confidential recorded. Other doctors and researchers get to see . Research data only in encrypted (and one can not identifiable ) form For publication purposes never personally announced. On research is not possible. Survey data are kept for 20 years after the end of the study . To check the study can to a representative of the client or to representatives of competent bodies such as the Health Inspectorate inspection are given in the medical record of the subject . This inspection will be the responsibility of the treating physician . Participation in the study means that permission is given. These inspection
Which medical ethics committee approved this study ?
The Medical Ethics Committee of the Academic Medical Center (AMC ) approved this study . 6

There is a charge given to the investigation ?
Travel expenses for the agreements that fall outside of your regular treatment appointments are reimbursed based on 2nd class train carriage , or if you are traveling with 18 cents per kilometer and parking costs by car.
I am also assured during the investigation ?
For any damage arising from the research is consistent with the statutory requirements, an insurance through Mutual Waarborgmaatschappij Centramed BA , PO Box 191 , 2270 AD Voorburg . The comprehensive insurance text can be found in Appendix 1A , the back of this newsletter .
Who are the contacts for any remaining questions ?
Should you have any questions before, during or after the examination , you can always contact the researchers Anneke Goudriaan , Esther Beraha or Elske Salemink , working at the University of Amsterdam and can be reached via :
Esther Beraha , MSc ( daily management research )
Tel. 020-5256871
Email: E.M.BerahaMenahem @ uva.nl
David de Jong
Tel. 020-5256871
Email: d.t.h.a.dejong @ uva.nl
Dr . Anneke Goudriaan
Tel . 020 8913 761
Email: a.e.goudriaan @ amc.uva.nl
Dr . Elske Salemink
Tel. 020-5258663
Email: E.Salemink @ uva.nl
The research is supervised by Prof. dr. Dr . Reinout Wiers , University of Amsterdam ( Tel. 020-5256842 ) and Dr. Natasha ( Tel. 0342-470930 )
Can I get independent information about the investigation?
It is possible for an independent physician , Dr. . H.C.M. Consult with questions or complaints about this study that you do not discuss with the researchers associated with this study . Defourny
Dr . H.C.M. Defourny , Tel . 0342-42706
attachments :
- Insurance Text
- General brochure medical research involving human subjects 7

Appendix 1A : Standard Text Insurance
According to the medical research involving human law has the AMC Ltd an insurance policy for medical research that damage caused by death or personal injury caused by the subject covered by the investigation.
* This is damage that manifests itself during or within four years of participation in research and reported within 4 years after the termination of the participation in the study . * The amount for which the insurance was taken was € 450,000 per participant , with a maximum of € 3.5 million for the entire research and € 5,000,000 for damage resulting from medical research that each insurance year reported .
The insurance provides coverage * for damage resulting from the realization of the related participation in the research risks that people are not informed in writing ; * for damage resulting from the realization of the risks which the participants have been informed , but in more serious mate occurs then is provided ; * for damage resulting from the realization of the risks which the participant is well informed , but that was considered highly unlikely .
The insurance does not cover damage * for damages resulting from the absence of a reduction in the health of the subject , or the result of the further deterioration of health , if the participation in the scientific research carried out in the under the treatment of health problems ; * for damage affecting the health of the subject, which it is likely that it would have revealed if the subject had not participated in the study; * for damage resulting from participation in medical research which in the professional circles usual acts in the field of medicine are compared and it is likely that the damage is the result of the actions taken; * for damages that a descendant of the subject reveals due to an adverse effect of research on the subject or the offspring ; * for damage caused by not or not fully follow directions and instructions by the subject , if the subject is capable of doing at least .
The insurance only covers damage from natural persons . The coverage of specific claims and expenses is limited to certain amounts .
In order to make a claim for damages , in case of alleged damages resulting from the investigation to report it to the subject : name of insurer: Centramed BA insurer address : PO Box 191 , 2270 AD Voorburg . policy number : 620 872 806
Furthermore , the subject is asked to contact Dr. A. Goudriaan ( tel. 020-8913761 ) in this regard. Contact 8

permission Statement
November 2012
Study Title : " The effect of baclofen in alcohol addiction - Who does it ?"
To be completed by the participant :
I hereby declare that I have received the information in the form of the newsletter , the general brochure and verbal information regarding the study and read.
I understand that I get medication for 18 weeks .
It is clear to me that participation in the study is voluntary and without obligations, that I know that I have the right to terminate conservation . My participation at any time This will in no way adversely affect further medical or non - medical treatment .
I could ask additional questions . My questions are adequately answered . I had plenty of time to decide whether I participate .
- I agree that my doctor is informed of my participation in this research:
- I agree that some people can see my data . Those people are listed in the General Brochure . This includes the Health Inspectorate , monitors and auditors .
- I agree that the researchers can see my medical record .
- I agree that during the study once saliva for genetic research is conducted .
- I agree that during the study my breath alcohol concentration is determined .
- I agree that my research will be kept for up to 20 years after the end of the study .
- I agree that my body material is kept for up to 20 years after the end of the study .
Yes / No ( Encircle all that apply )
- I agree that I contacted in the future for possible follow-up study by the researchers :
Yes / No ( Circling as applicable ) 9

- I assure that I am not pregnant at the moment and will ensure that I will not get pregnant during the study . If I get pregnant, I will report this immediately to the researchers.
Name (surname and initials ) :
place :
Date :
signature:
To be completed by the researcher :
I hereby declare that I am fully informed about the study said . These subjects
I will vouch that the confidentiality of any information and will not be violated by employees in the study. Anonymity will be guaranteed .
Name responsible researcher :
( surname and initials )
place :
Date :
signature:"

**skullbabyland** · March 13, 2014, 10:55 AM

Baclofen trial by the University of Amsterdam

Thanks much for posting all this, X.

Welcome Guest to My Way Out Forums.

Announcement

Baclofen trial by the University of Amsterdam

Baclofen trial by the University of Amsterdam

Comment

Comment

Comment