Alcoholism can be successfully treated in primary care settings, when brief sessions with health professionals are coupled with either the drug naltrexone or specialized counseling, according to new clinical trial results published in JAMA.
The randomized, controlled trial, called “Combining Medications and Behavioral Interventions for Alcoholism,” or COMBINE, is the largest ever conducted of drug and behavioral treatments for alcohol dependence. COMBINE included 1,383 subjects at 11 clinical sites across the country. Brown Medical School oversaw the largest site, enrolling 133 patients through Roger Williams Medical Center.
Robert Swift, M.D., served as principal investigator of the Roger Williams site and is an author of the JAMA report. Swift, a professor of psychiatry and human behavior and associate director of the Center for Alcohol and Addiction Studies at Brown Medical School and associate chief of staff for research at the Providence V.A. Medical Center, has studied alcoholism and drug addiction for more than 20 years. He said the COMBINE results send a clear message to problem drinkers – and the doctors who care for them.
“Medical care works – and alcoholics don’t need to check into a specialty treatment program to get it,” Swift said. “We found that just nine 20-minute sessions with a medical professional, in conjunction with naltrexone or intensive counseling, yields good clinical results. This is a critical finding. While an estimated 8 million Americans are alcoholics, fewer than 1 million get treatment. Yet alcoholism has serious medical consequences and devastating societal effects. COMBINE shows that medical management, along with naltrexone or therapy, can significantly help people with this disease.”
Richard Longabaugh, a clinical psychologist and professor of research in the Department of Psychiatry and Human Behavior, served as co-investigator at the Brown site. Longabaugh, who has researched treatments for alcoholism for 25 years, is also an author of the JAMA report.
“The finding that alcoholism can be treated in a primary care setting is good news,” Longabaugh said. “This makes confronting this disease a lot simpler. And this should make effective treatment available to a much larger number of people who need it.”
COMBINE set out to test the best treatments for alcohol dependence, in a variety of combinations, to see whether medication and therapy pairings would have an additive benefit.
Two drugs were tested. One is naltrexone, which blocks some of the brain’s pleasure receptors and reduces alcohol cravings. The other is acamprosate, a medication that modifies different brain receptors and is more recently approved by the U.S. Food and Drug Administration to treat alcoholism. Researchers also tested a new form of therapy called combined behavioral intervention, or CBI, which uses treatment techniques that boost motivation, promote self-help programs, help cope with drinking triggers, and improve refusal skills for achieving and maintaining abstinence. Trained therapists led these 50-minute, one-on-one sessions.
Finally, COMBINE researchers created a new intervention to test. Called medical management, or MM, the treatment is based on care given to patients with other chronic illnesses, such as diabetes. Trained medical professionals – doctors, nurses, physician assistants or pharmacists – first reviewed the diagnosis, recommended abstinence and dispensed pills. In 20-minute follow-up visits, providers asked about a patient’s drinking, general health, and medication adherence and dispensed additional medications.
All trial participants were alcohol dependent patients who recently abstained from drinking. They were randomly assigned to one of nine treatment groups:
1. MM, naltrexone and placebo acamprosate
2. MM, acamprosate and placebo naltrexone
3. MM and both acamprosate and naltrexone
4. MM and double placebo
5. MM, naltrexone and placebo acamprosate plus CBI
6. MM, acamprosate and placebo naltrexone plus CBI
7. MM and both acamprosate and naltrexone plus CBI
8. MM and double placebo plus CBI
9. CBI only, plus four doctor’s visits
After 16 weeks, researchers found that patients who received MM and naltrexone and those who received MM and CBI were the least likely to relapse into heavy drinking, defined as five or more drinks a day for men and four or more drinks for women. One year after treatment, patients who received naltrexone continued to have fewer relapses and reported fewer alcohol cravings.
Some of the results were surprising. Researchers found no additive benefit from combining the two drugs and no effect on drinking for acamprosate, which had shown promise in treating alcoholism in Europe before being approved by the FDA in 2004.
Swift said another finding is intriguing: Every group substantially improved. Overall, the percentage of days abstinent tripled, from 25 to 73 percent during treatment. Alcohol consumption per week also dropped dramatically, from an average of 66 drinks to 13.
“What was really compelling is that people did well, regardless of the specific treatment,” Swift said. “There may be a few explanations for this. One is the placebo effect from taking a pill. The other answer may lie in the fact that all but one of the trial groups received medical management. Having someone check on a patient’s progress, assess their health and provide encouragement – routine practice in treating high blood pressure or diabetes – speaks to the power of sustained, professional medical care.”
To encourage the use of medical management, the National Institute on Alcohol Abuse and Alcoholism will include an abbreviated version of the protocol in its Clinician’s Guide, which the institute expects to release in early summer. The COMBINE team, meanwhile, is conducting a cost-benefit analysis on medical management with either naltrexone or CBI and will also study DNA samples from trial participants to try and better understand the role genes may play in predicting responses to drugs or therapy.
The National Institute on Alcohol Abuse and Alcoholism funded the research.
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