Healthy male and females aged 18-65 are needed for a paid clinical trial testing a new drug for the potential treatment of Opioid dependence which is a form of drug addiction. This study will involve 1 screening visit and 1 admission period of 8 days/7 nights.
Participants will be compensated £1,715 on study completion for their time and inconvenience.
Participants must meet the following criteria:
- Females must not be pregnant, lactating or planning to get pregnant within 90 days after receiving last dose of study drug
- You should have a body-mass index of 18.5 -30 and weigh between 50kg and 100kg (you can calculate your BMI in the pre-screening form)
- You must not have taken part in another clinical trial within the last 3 months prior to dosing
- You must not have been dosed on Part A of this study
- You must be in good health and not suffer from any medical conditions
- You must be a non-smoker or former smoker (you must have refrained from all nicotine products for at least 60 days before screening)
There are other reasons why you may or may not qualify for this study. You can find out now if you can take part by completing the short pre-screening form.
Before Part B of the study will start, the results from Part A will be used to confirm the doses used in Part B of the study. The drug being tested in this study is RBP-6300 ADF, this is a drug that has the potential to treat Opioid dependency and prevents cold turkey symptoms. The main ingredient of this drug is Buprenorphine Hemiadipate Hydrochloride (BH) SUBUTEX (the drug used in period 1 of Part A) has been marketed in over 30 countries worldwide and contains a similar drug combination (BH) but has a different dosing route. By comparing the two formulations it is hoped that the new drug will provide a more convenient route of administration, and will deter potential abuse (cannot be injected).
Group 2.1: Inpatient Stay: Thursday 26th November – Thursday 3rd December
Group 2.2: Inpatient Stay: Tuesday 8th December – Tuesday 15th December
Screening (Visit 1)
This will involve a doctor going through your medical history and a physical examination. You will have a number of tests during screening including vital signs (heart rate, blood pressure, respiratory rate and temperature), measurement of your height and weight, blood and urine tests. This appointment along with confirmation of your medical history from your GP will determine your eligibility to take part in the trial.
Inpatient Stay (Visit 2)
You will have a series of tests carried out similar to those completed at screening. An intravenous cannula (a fine plastic tube) will also be inserted into one of the veins in your forearm, through which blood samples will be taken to measure levels of the study drug in your blood. You will receive a single oral administration of either 24 mg RBP-6300 ADF or 36 mg RBP-6300 ADF after fasting for approximately 10 hours. You will also receive Naltrexone tablets by oral administration (a drug that is administered to block the side effects of the study drug) in the evening of admission, then about an hour before the study drug administration and at 24-hour post dosing. There will be no follow up for this study.
Before every clinical trial, each medicine has undergone extensive laboratory testing, and every trial has to be approved by the MHRA (Medicine and Healthcare products Regulatory Agency) and an Independent Research Ethics Committee, who will evaluate and ensure the wellbeing of the volunteers is safeguarded.
The trials are such a valuable part of the process as they are stringently designed to guarantee the quality, reliability, and safety of new medicines.
In the last seven years, Quintiles Drug Research Unit at Guy’s Hospital has conducted over 1000 Phase 1 development studies worldwide. This has seen thousands of paid volunteers taking part in the trials, each making a hugely valuable contribution to medical research.
Quintiles Drug Research Unit at Guy’s Hospital is based in London and has over twenty years of Phase 1 clinical research experience in this unit, and this site alone has been involved in the testing of more than 200 potential new medicines.
If you would like to register to take part in a clinical trial at Quintiles Drug Research Unit at Guy’s Hospital you can do so via our secure online form.
By registering you are not making a commitment but simply expressing an interest to find out more. We will ask you a few more details about your health and will then discuss what studies you may be suitable for.
Studies will be approved by a recognized independent Research Ethics Committee.