Airway Sensory Replacement Combined With Nicotine Replacement for Smoking Cessation

A Randomized, Placebo-Controlled Trial Using a Citric Acid Inhaler

¹ From the Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center and Division of General Internal Medicine, Duke University, Durham, NC
² From the Nicotine Research Laboratory, Durham Veterans Affairs Medical Center, and Department of Psychiatry, Duke University Medical Center, Durham, NC

Study objective: This study was conducted to determine if the combination of airway sensory replacement and nicotine replacement improves 10-week smoking abstinence rates over nicotine replacement alone.

Design: Double-blind, randomized, placebo-controlled trial.

Setting: Outpatient research clinic.

Participants: One hundred healthy volunteers who smoked at least one pack of cigarettes per day and desired to quit smoking.

Interventions: Subjects received either citric acid (n=41) or lactose placebo (n=59) inhalers to cope with smoking urges for 10 weeks. All subjects received self-help materials and nicotine patches for 6 weeks. Return visits were at weeks 1, 4, 6, and 10. Abstinence was defined as zero cigarettes smoked since the quit date verified by exhaled carbon monoxide 8 ppm at all return visits. Inhaler effects were measured by a standardized questionnaire.

Measurements and results: The primary outcome of continuous abstinence at the end of the 10-week treatment period was 19.5% (95% confidence interval [CI]=7.4 to 31.6%) for the citric acid group vs 6.8% (95% CI=0.4 to 13.2%) for the lactose group (p=0.05). Relief from craving and short-term abstinence increased as airway sensations from the inhaler also increased. Abstinence at 10 weeks for subjects receiving strong airway sensations from the inhalers was 33.3% (95%CI=14.5 to 52.1%). At 6 months, there was no difference in abstinence between the treatment groups (0% vs 5.1%, p=0.20).

Conclusions: When combined with the nicotine patch, the citric acid inhaler improved 10-week smoking abstinence over lactose inhaler. The combination of airway sensory replacement and nicotine replacement may prove beneficial for smoking cessation.

Key Words: citric acid • nicotine patch • smoking cessation

Submitted on May 9, 1994
Accepted on September 21, 2007

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