Nicotine patches may help more adolescent patients addicted to tobacco to abstain from smoking than placebo, according to the results of one of the few double-blind, randomized trials of its kind.

In the pilot study, significantly more adolescents who received patches had continuous abstinence from cigarette smoking after 2 weeks (6 of 34, 18%) than those who received placebo (1 of 40, 3%).

Patients treated with nicotine gum abstained from smoking after 2 weeks at a rate similar to placebo patients (3 of 46, 7%), reported Eric T. Moolchan, M.D., and his colleagues at the National Institute on Drug Abuse (Pediatrics 2005;115:e407–14).

Each group had slightly higher rates of abstinence at the end of the first week of treatment—when follow-up monitoring of patients might begin in a standard medical practice.

But 2 weeks after randomization, cessation rates had fallen among all three groups.

At the end of the 3-month study, however, abstinence rates among the patch and placebo groups had climbed. Specifically, those rates stood at 21% in patch patients, 9% in gum patients, and 5% in placebo patients.

“To date, most of the studies [on nicotine replacement therapy for adolescent smokers] have not found much effect, but most of the studies have been very small and have limitations in their design,” said Douglas M. Ziedonis, M.D., director of the division of addiction psychiatry at the Robert Wood Johnson Medical School, New Brunswick, N.J., who was asked to comment on the study.

All patients in the study received weekly, 45-minute sessions of cognitive-behavioral therapy.

Psychosocial treatment in adult smokers improves the results of nicotine replacement medications by about 50%, Dr. Ziedonis said. But in the United States, only 3% of adults who are trying to quit get both medication and psychosocial treatment.

“With any other addiction, we would think it's crazy not to provide psychosocial treatment and medication,” he said in a telephone interview.

The study included adolescents aged 15 years on average who began smoking around age 11 years.

These highly tobacco-dependent patients smoked an average of about 19 cigarettes per day.

“It is important to note that 75% of the adolescents [in this study] had co-occurring mental illness,” Dr. Ziedonis said.

The most common diagnoses included oppositional defiant disorder (40%), conduct disorder (15%), premenstrual dysphoric disorder (11%), and attention-deficit hyperactivity disorder (7%).

The Substance Abuse and Mental Health Services Administration now defines the combination of tobacco addiction and mental illness as a type of co-occurring disorder.

“Unfortunately, I think of all the addictions, mental health staff have been the least trained on tobacco, even though they see that [addiction] the most,” Dr. Ziedonis said.

Even though nicotine patches and gum are sold over-the-counter (OTC), they cannot be sold legally to a person younger than 18 years of age.

An older family member could buy an OTC product for an adolescent, or a physician could prescribe a smoking cessation product or provide a written recommendation for an OTC product, he advised.

In many states, internet sites and telephone lines offer help to teenagers who want to quit smoking, in addition to “quit centers” where adolescents can get OTC nicotine replacement products and counseling in an individual or group format, Dr. Ziedonis pointed out.

Many quit centers require parental permission to distribute OTC medication, he said.

In the trial, all groups self-reported a mean reduction in cigarettes smoked per day that exceeded 80% at the end of treatment.

But objective measurement of smoking through expired carbon monoxide and levels of thiocyanate in saliva did not change from baseline to the end of treatment in any group.

The investigators suspected that the discrepancy between self-reports of reduced smoking and biomarkers of smoke exposure may have occurred because of compensatory smoking through deeper inhalation or inaccurate reporting by the adolescents.

“Although these results do not answer definitely the question of the efficacy of the patch or gum for treating adolescent smokers, the current findings lend empirical support to the U.S. Public Health Service clinical practice guideline for pediatricians, family practitioners, and other practitioners to prescribe or to recommend more consistently the nicotine patch, in addition to developmentally appropriate behavioral and counseling support, for adolescent smokers who are attempting to quit,” the researchers wrote.

The investigators designed the study to have sufficient statistical power to detect a significant reduction in cigarette smoking but not a cessation effect. A previous report noted that a reduction in exposure to tobacco may be an adequate intermediate treatment goal for adolescent smokers since they often encounter “lower systemic support for quit attempts, and potentially less motivation, preparation, and success in achieving total cessation,” than adults, Dr. Moolchan and his associates wrote.

Adverse events that were reported significantly more often with patches (pruritus, erythema, and shoulder or arm pain) or with gum (pruritus, sore throat, and hiccups) than with placebo occurred at rates similar to those observed in previous studies with adults.

Nicotine Patch May Be Best for Adolescent Smokers