A Safe and Effective Way to Quit Smoking: Nicotine Mouth Spray

Nicotine mouth spray offers smokers a safe and effective way to quit, even in naturalistic settings and without behavioral support, according to findings recently published in Nicotine & Tobacco Research.
 
“With the exception of nicotine nasal spray, which has limited appeal because of its initial local irritation, currently available forms of [nicotine replacement therapy] are constrained by relatively slow systemic nicotine absorption,” said Dr. Mitchell Nides, founder and president of Los Angeles Clinical Trials.

Because cigarette craving after quitting, along with exposure to smoking-related cues, is thought to play an important role in relapse, it has been suggested that the effectiveness of [nicotine replacement therapy] could be improved if the treatment can relieve situational cravings more quickly and more effectively, they added.

Researchers randomly assigned 1,198 patients to receive either a 1 mg nicotine mouth spray as needed each day or a placebo for 26 weeks, with baseline carbon monoxide levels recorded.

Nides and colleagues found that the carbon monoxide-confirmed continuous abstinence rate from weeks 2 through 6 was higher in the nicotine mouth spray group than in the placebo group (5% vs. 2.5%, P=0.021). Patients receiving the nicotine mouth spray showed a statistically significant treatment effect throughout the full 26-week study period. The nicotine mouth spray was well tolerated, with no clinically significant differences in participants’ vital signs. Reported adverse effects included hiccups, nausea, and headache.

“To simulate an [over-the-counter] environment, there were very few inclusion/exclusion criteria. Subjects with contraindicated conditions, such as diabetes and uncontrolled hypertension, could be enrolled with the consent of the subject’s physician, as could subjects taking medication for depression or anxiety, or opioid pain medication. Normally, these subjects are excluded from controlled trials. In addition, while motivation to quit smoking with the aid of a new nicotine replacement therapy was a criterion for entry, no cutoff level for motivation was established, which may have contributed to lower quit rates.

They added: “Unlike typical controlled clinical study designs, in which various forms of intensive intervention and measures are used to create a tightly controlled environment, this study did not provide behavioral counseling or support from study personnel.”

The researchers concluded that nicotine mouth spray is “another option for smokers who want to quit.”