Combining Medications and Behavioral Interventions
Sponsored by the National Institute of Alcohol Abuse and Alcoholism

The Combining Medications and Behavioral Interventions (COMBINE) project is a multi-center, randomized, controlled clinical trial sponsored by the National Institute of Alcohol Abuse and Alcoholism (NIAAA).Under investigation is whether combinations of pharmacologic and behavioral therapies are superior to monotherapy in the treatment of alcohol dependence. The trial will include eleven clinical centers and approximately 1,400 patients.

There are a number of ways to help people with alcohol problems. COMBINE is a study funded by the National Institute on Alcohol Abuse and Alcoholism, designed to test how well different combinations of medication and psychotherapy help people with alcohol problems.

What medications are being used?

The two medications are Naltrexone and Acamprosate. Neither drug has been found to be addictive. Naltrexone is a medication that has been used in this country for a number of years and has been found to reduce alcohol craving. Acamprosate, a drug that has been prescribed in Europe for over 14 years but is not yet approved in the U.S., has been shown to help increase abstinence and reduce the likelihood of relapse to drinking.

As a participant in this study, you may receive one or the other of these medications, the combination of the two medications, a placebo (an inactive pill), or individualized behavioral treatment without medication. If you are given pills to take, you will not know if you are taking the real medication or the placebo, but 3 out of 4 participants given pills will receive at least one of the two active medications.

What counseling approaches are being used?

One type of therapy will focus on medication issues, general health issues, and drinking. As part of this treatment, you will be encouraged to attend self-help groups such as Alcoholics Anonymous or SMART Recovery. The second type of behavioral treatment includes additional components designed to help people to: (1) increase their motivation to manage their alcohol problems, (2) participate in self help groups, and (3) learn new skills to cope with problems and avoid drinking.

How long will I be involved?

If you are enrolled in the study, you will receive up to 16 weeks of medication and/or counseling. Research staff members will also meet you with during these 16 weeks of treatment. After treatment ends, you will return for three follow-up visits over the next 12 months to see how you are doing. These interviews and lab tests take about one hour.

What is My Part in the Study?

ASSESSMENT

When you come in to learn about the study the risks and benefits of the study will be explained. You will be interviewed, complete some paper & pencil questionnaires, and undergo some lab tests and a brief medical exam before you are accepted for participation in the study. If you are not eligible for participation in COMBINE, other treatment options will be explained to you.

The study is not appropriate for persons under 18 or who are pregnant or thinking about becoming pregnant.

TREATMENT

If you are eligible, you will be randomly assigned (i.e., by chance) to one of nine different treatment conditions. All patients will receive one of the two forms of counseling. Eight out of nine patients will also receive pills containing some combination of active or inactive medicine. Finally, one out of nine patients will receive the individualized counseling without any pills. Everyone who receives medications will meet regularly with a medical professional, such as a nurse or doctor. A little more than half of the participants will receive behavioral counseling provided by an experienced psychotherapist for 16 weeks, or up to 20 sessions.

How often will I have to come for appointments?
Frequency of visits will vary depending on the treatment group to which you are assigned. However, most participants will initially have appointments once or twice a week.

Who else will be involved in my treatment?

Depending on the treatment you receive, you may be asked to have your spouse or a significant other attend with you some of the therapy sessions. This person’s involvement may help your treatment be more effective.

Will I have to pay for my treatment?

No! There is no charge for any assessment, medication, treatment or lab tests you will receive as part of the study.

Is the program confidential?

Yes! All of the information that you provide in this project will be kept confidential. You will be assigned a confidential code number so your name will not be associated with information given or identified anywhere in the research results. Research files will be kept separate from your hospital medical records.

What are my responsibilities?
You are expected to show up for your appointments on time, and free of alcohol. If you are unable to attend a session, you should let the study staff know at least 24 hours in advance. You are also expected to take the pills as prescribed and you must return the medication packages regardless of whether or not you took all the medications.

I’m interested. What do I do next?

Your participation in COMBINE is valuable and greatly appreciated. You will be helping us to improve treatment for many others, while you receive high-quality treatment yourself.

If you are interested in learning more about COMBINE please | click here |