Taking Your Medications
The medications you will receive in this study are expected to treat the withdrawal symptoms you might feel when you stop taking opioid drugs. If you take your medications as your doctor instructs and discontinue your use of illicit (non-prescribed) opiates, you increase your chances that the medications will work well. Taking medications every day is a challenge, but not an impossible one. You may get support from friends, family, or the study staff.
Attending Study Visits
Medical monitoring
Your doctor, study nurses, and/or research assistants will follow you closely during the first 14 days of the study to find out if your medications are working. They will also try to find out if you are having any harmful side effects from the drugs. It is very important that you come to these study visits. The visits may allow your doctor to find problems and treat them before you have any unnecessary discomfort.
Follow-up visits
In addition to the medical monitoring, you will need to return to the clinic at 1, 3, and 6 months. These visits will include:
- Questions about your health and how you are feeling
- Questions about drugs you are taking (prescription and non-prescription)
- Questions about how you are doing in different areas of your life
Reporting Symptoms
You will need to play an active part in your health care. You will need to contact your study doctor, nurse, or research assistant if you have serious health problems between visits, especially during detoxification (first 14 days of the study). Health problems could be side effects of the study medications or symptoms of withdrawal from drugs you are taking. Some of the side effects or symptoms could be harmful if they are not treated. You should not wait until your next study visit to report these if they are serious. The research assistants will ask you how you have been feeling during the follow-up visits regardless of whether you have reported any side effects or symptoms in the past.
Your doctor or nurse will give you a list of symptoms for the medications that you are taking. A list of withdrawal symptoms from opioid drugs follows. Some of these symptoms may be caused by other problems, including continued drug use or other illnesses. Report them, and let your doctor find out what is causing them.
Symptoms of opioid withdrawal:
- Depression or anxiety
- Nausea or vomiting
- Muscle aches
- Watery eyes or runny nose
- Goose bumps or sweating
- Diarrhea
- Yawning
- Fever
- Sleeplessness
Using Birth Control
The medications used in this study have been classified as Category C. That means that risk to the fetus cannot be ruled out because there have been no adequate, well-controlled studies of these medications in pregnant women. However, these medications may be used with caution during pregnancy because the potential benefits might outweigh the potential risks.
If you are a woman who is able to have children, you should do everything you can to avoid becoming pregnant while taking your study medications. You will receive a pregnancy test prior to receiving any medications in this study. If you do become pregnant, you should tell your doctor as soon as you can. Your doctor will discuss your options with you.
Even though male latex condoms may be the best means of disease control, they may not be the best means of birth control for you. The following table lists common birth control methods. It also lists the rates at which they keep someone from getting pregnant.
Method |
Rate at which it prevents pregnancy |
| Pill |
99% |
| Mini-pill |
96% |
| Norplant |
99% |
| Shots |
99% |
| IUD |
97-99% |
| 1Gels, foams, or creams that kill sperm |
80% |
| Diaphragm |
85% |
| 1Female condom |
75-85% |
| 1 Male condom |
80-90% |
Complete abstinence
from intercourse |
100%?? |
| Sponge |
85-90% |
| Emergency contraception |
90-95% |
| Natural family planning |
65-95% |
| Female sterilization |
99% |
| Male sterilization |
99+% |
NOTES:
The pregnancy prevention rate may increase if you use two of the methods instead of one. For example, the rate for a male condom with gels, foams, or creams that kill sperm may be higher than the rate for a condom alone. Discuss these methods with your study nurse or doctor when you are making choices about birth control and methods for halting the spread of sexually transmitted diseases, including HIV.
Items in bold indicate those methods which are acceptable and necessary for women who are able to become pregnant to participate in this study. |
1 Gels, foams, or creams that kill sperm must be used along with male or female condom |
For more information on the National Drug Abuse Treatment Clinical Trials Network, visit the NIDA website at www.drugabuse.gov.
For information on other clinical trials, the National Institutes of Health (NIH) has created a website to help patients, family members, and the general public obtain information about government sponsored clinical trials. You may log on to www.Clinicaltrials.gov to learn about ongoing or new trials for all types of health related conditions. The descriptions for individual trials include eligibility criteria, purpose of the trial, location, and how to apply if interested. The website is maintained and updated regularly by the National Library of Medicine.
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