Introduction

You are invited to take part in a research study. The study will test whether supportive telephone calls after leaving this program help people to stay involved with continuing care and to stay off of drugs.

Procedures

If you are interested in joining the study, here’s what you can expect:

Screening: You will meet with a research assistant to answer some questions to see if you are able to join the study

Informed consent: After learning all about the study, and having a chance to ask questions, you will be asked to give written permission to participate

Research interview: You will be asked to answer questions about your substance use,HIV risk behavior, and other informationabout your life (1-2 hours)

Locator information: You’ll be asked to provide information to help us reach you after discharge. This information will be written down.

Everyone who is in the study will:

• Participate in the treatment program as usual at this clinic

• Receive a continuing care plan as usual at this clinic

• Meet with the study counselor to review your continuing care plan

• After completing these procedures, you will be assigned to receive either usual continuing care or usual continuing care plus telephone calls. You will be assigned randomly, like the flip of a coin. This means that you will not get to choose whether or not to receive the phone calls.

• If you are in the telephone call group, you will follow your continuing care plan and you will receive telephone calls during weeks 1, 2, 4, 6, 8, 10, and 12 after discharge. Each telephone call will last 15-30 minutes. You will need to make every effort to be by the telephone at the scheduled time. If you miss an appointment, the researchers will contact the person listed on the locator form in order to try to reach you. The telephone calls with the counselor will be recorded. Nobody except your telephone counselor will know who is speaking on the telephone calls. The recordings will be used to make sure the counselors are doing what is needed during the telephone calls. The recordings will be destroyed after the researchers have listened to them.

• If you are in the usual care group, you will follow your continuing care plan after discharge.

• Everyone who is in the study will attend a 1-hour follow-up visit at week 13 after discharge. During this follow-up visit you will answer questions about your substance use, life, and feelings, give a urine sample for drug testing, and give a breath sample for alcohol testing.

Questions

These are the answers to questions you might have about the study. They may help you decide if you would like to join.

1. How long will I be in the study?

The study will last for 13 weeks after you leave the residential program.

2. What will I get for taking part in the study?

Taking part in the study may help you to stay off drugs. If you are in the telephone call group, you will have more contact with the study counselors after discharge than you would otherwise. You will be given $25 in cash or script after you have completed all admission procedures for the study. You will be given an additional $25 after you have completed the follow-up visit.

3. Will I have any bad effects from taking part in the study?

There are few risks related to being in this study. One possible risk is that you may continue to use drugs but that is a risk whether or not you choose to join.

4. What if I don’t want to get telephone calls anymore or don’t want to answer anymore research questions?

You are free to withdraw from the study at any time. If you no longer want to be in the study, you should tell the research assistant as soon as possible. Your treatment will not be affected if you decide not to join, or if you change your mind after joining the study and drop out.

FOR MORE INFORMATION

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.

National Institute on Drug Abuse
Center for the Clinical Trials Network
6001 Executive Boulevard
Room 4234, MSC 9557
Bethesda, Maryland 20892-9557
Telephone: (301) 443-6697
Fax: (301) 443-2317