A 12-Week Double-Blind, Placebo-Controlled Study of Bupropion SR Added to High-Dose Dual Nicotine Replacement Therapy for Smoking Cessation or Reduction in Schizophrenia

Abstract

The objective of this study was to examine whether there is a benefit of adding bupropion SR to high-dose combination nicotine replacement therapy (NRT) and weekly group cognitive behavioral therapy (CBT) for smoking reduction or cessation in schizophrenia. Fifty-one adult smokers with schizophrenia were randomly assigned to a 12-week trial of bupropion SR 300 mg/d or placebo added to transdermal nicotine patch, nicotine polacrilex gum, and CBT. The treatment goal was smoking cessation. The primary outcome measure was biochemically confirmed 7-day point-prevalence of 50% to 100% smoking reduction at week 12. Secondary outcomes were biochemically confirmed tobacco abstinence and change from baseline in expired air carbon monoxide (CO) and psychiatric symptoms. Subjects on bupropion + NRT had a greater rate of 50% to 100% smoking reduction at weeks 12 (60% vs. 31%; P = 0.036) and 24, a lower expired air CO in the treatment and follow-up periods, (F = 13.8; P < 0.001) and a greater continuous abstinence rate at week 8, before NRT taper, (52% vs. 19%; P = 0.014). However, relapse rates in subjects on bupropion + dual NRT were 31% during NRT taper (weeks 8-12) and 77% at the 12-month follow-up. Abstinence rates did not differ by treatment group at weeks 12 (36% vs. 19%), 24 (20% vs. 8%), or 52 (12% vs. 8%). Because abstinence rates were high during treatment with combination pharmacotherapy and relapse rates were very high during taper and after discontinuation of treatment, study of longer term treatment with combination pharmacotherapy and CBT for sustained abstinence is warranted in those who attain initial abstinence with this intervention.

A Placebo-Controlled Trial of Bupropion Combined with Nicotine Patch for Smoking Cessation in Schizophrenia

“…Our results are similar to a another study of the combination of BUP with high dose NRT (patch + gum) to NRT alone in schizophrenia [32]. In this trial, significant effects of the combination were noted on short-term abstinence during the trial (p<0.03; NNT=5), but the difference between groups on long-term abstinence (13.8% vs 0.0%) was not significant (p=0.11; NNT=8).…”

Effects of Bupropion on Cognitive Function in Schizophrenia: A Double Blind Randomized Controlled Trial

“…This is consistent with Evins et al's study in which any statistically significant difference was not observed (Evins et al, 2007;.…”

Combination Extended Smoking Cessation Treatment Plus Home Visits for Smokers With Schizophrenia: A Randomized Controlled Trial

“…A related limitation is the absence of control groups other than TAU. This absence led to the study being unable to differentiate which components of the COMB-EXT were essential in leading to improved outcomes (though both the combination and extended parts of the treatment can clearly be inferred as being helpful for relapse prevention, based on prior studies 24,75 ). The study was also limited by the absence of a motivation to quit rating scale, though all participants expressed a desire to obtain smoking cessation treatment and quit, so we speculate that they fell within a relatively narrow range of motivation levels.…”

“…To our knowledge, only two studies have used combinations of treatments similar to the ones administered here in smokers with schizophrenia, and these studies provided treatment for a standard (not extended) amount of time. In one such study, 75 CBT, bupropion, and NRT were administered in typical dosages, with NRT started at week 4 and study medications tapered (and CBT stopped) at week 12. In that study, smokers with schizophrenia in the experimental group had a higher quit rate than the control group at week 8, but not at week 24 after acute treatment was discontinued.…”