RATIONALE: Varenicline is believed to work, in part, by reducing craving responses to smoking cues and by reducing general levels of craving; however, these hypotheses have never been evaluated with craving assessed in the natural environments of treatment-seeking smokers. OBJECTIVES: Ecological momentary assessment procedures were used to assess the impact of varenicline on cue-specific and general craving in treatment-seeking smokers prior to quitting. METHODS: For 5 weeks prior to quitting, 60 smokers carried personal digital assistants that assessed their response to smoking or neutral cues. During week 1 (baseline), participants did not receive medication; during weeks 2-4 (drug manipulation), participants were randomized to receive varenicline or placebo; during week 5 (standard therapy), all participants received varenicline. Craving was assessed before each cue; cue-specific craving and attention to cue were assessed after each cue. RESULTS: During all phases, smoking cues elicited greater craving than neutral cues; the magnitude of this effect declined after the first week. General craving declined across each phase of the study. Relative to the placebo condition, varenicline was associated with a greater decline in general craving over the drug manipulation phase. Varenicline did not significantly attenuate cue-specific craving during any phase of the study. CONCLUSIONS: Smoking cues delivered in the natural environment elicited strong craving responses in treatment-seeking smokers, but cue-specific craving was not affected by varenicline administered prior to the quit attempt. These findings suggest that the clinical efficacy of varenicline is not mediated by changes in cue-specific craving during the pre-quit period of treatment-seeking smokers.
RCT Entities:
RATIONALE: Varenicline is believed to work, in part, by reducing craving responses to smoking cues and by reducing general levels of craving; however, these hypotheses have never been evaluated with craving assessed in the natural environments of treatment-seeking smokers. OBJECTIVES: Ecological momentary assessment procedures were used to assess the impact of varenicline on cue-specific and general craving in treatment-seeking smokers prior to quitting. METHODS: For 5 weeks prior to quitting, 60 smokers carried personal digital assistants that assessed their response to smoking or neutral cues. During week 1 (baseline), participants did not receive medication; during weeks 2-4 (drug manipulation), participants were randomized to receive varenicline or placebo; during week 5 (standard therapy), all participants received varenicline. Craving was assessed before each cue; cue-specific craving and attention to cue were assessed after each cue. RESULTS: During all phases, smoking cues elicited greater craving than neutral cues; the magnitude of this effect declined after the first week. General craving declined across each phase of the study. Relative to the placebo condition, varenicline was associated with a greater decline in general craving over the drug manipulation phase. Varenicline did not significantly attenuate cue-specific craving during any phase of the study. CONCLUSIONS: Smoking cues delivered in the natural environment elicited strong craving responses in treatment-seeking smokers, but cue-specific craving was not affected by varenicline administered prior to the quit attempt. These findings suggest that the clinical efficacy of varenicline is not mediated by changes in cue-specific craving during the pre-quit period of treatment-seeking smokers.
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