Data address physicians' concerns about prescribing the medication for smokers with schizophrenia.

By Lori Whitten, NIDA NOTES Staff Writer

The smoking-cessation aid bupropion is safe and effective for people with schizophrenia, researchers at Massachusetts General Hospital and Harvard Medical School have found. In a NIDA-funded study of smokers with schizophrenia, those who took sustained-release bupropion were more likely to stop smoking by their quit date and to achieve continuous abstinence for a month than those who received placebo, and they also remained abstinent longer. The researchers did not observe any adverse interactions with the patients' antipsychotic medications or exacerbation of psychiatric symptoms.

The U.S. Food and Drug Administration (FDA) approved sustained-release bupropion as a treatment for depression in 1996 and as a smoking-cessation aid in 1997, but physicians have been reluctant to prescribe the medication for patients with schizophrenia. "Although 75 to 85 percent of people with schizophrenia smoke, we have lacked data on treatments for nicotine addiction in this population, resulting in many not receiving advice to quit," says Dr. A. Eden Evins, lead investigator of the study.

Dr. Evins and her colleagues treated 53 patients, aged 24 to 66, for nicotine dependence. When they began treatment, the patients smoked 30 cigarettes a day, on average, and typically had made two previous quit attempts. During the 12-week study, each participated in weekly sessions of group cognitive-behavioral therapy (CBT) and received either 300 milligrams a day of sustained-release bupropion or placebo. The CBT program was adapted for patients with schizophrenia from standard smoking-cessation therapy. Each patient visited the clinic once a week for evaluations of smoking (self-report confirmed by expired air carbon monoxide measurements), changes in psychiatric symptoms, medication compliance, and side effects.

Therapists encouraged all patients to set a quit date before the 4th week of treatment, and 36 percent of those taking bupropion—compared with 7 percent of those on placebo—achieved this goal, demonstrating abstinence at the 4-week assessment. Sixteen percent of patients in the bupropion group, but none taking placebo, achieved abstinence throughout the last month of treatment. Among patients who were not abstinent at the end of the study, those in the bupropion group reduced the average number of cigarettes smoked daily from 34 to 9, compared with a drop from 25 to 15 in the placebo group.

Bupropion was generally well tolerated and did not exacerbate the symptoms of schizophrenia. Depression and flat affect, as well as cognitive function, tended to improve among patients taking the medication. Common side effects experienced by people taking antipsychotic medications, such as muscle stiffness and shuffling gait, were not worsened by nicotine abstinence or bupropion. About 80 percent of patients in both the medication and placebo groups kept to their regimens throughout the study.

The findings confirm promising results from several smaller studies. Dr. Evins points out that the relapse rate was high after treatment discontinuation—75 percent of those who were abstinent at week 12 had relapsed to smoking at the 3-month followup. Only about 4 percent of patients in either group were abstinent in the week before the 3-month followup. Other studies of bupropion in the general population have shown that about half of patients tend to relapse after treatment discontinuation. "Patients with schizophrenia may need a longer course of bupropion with CBT or a combination of bupropion and nicotine replacement therapy to avoid relapse," says Dr. Evins.

Source

Evins, A.E., et al. A double-blind placebo-controlled trial of bupropion sustained-release for smoking cessation in schizophrenia. Journal of Clinical Psychopharmacology 25(3):218-225, 2005. [Abstract]

Volume 20, Number 5 (April 2006)