RANDOMIZED, CONTROLLED TRIAL OF TRANSDERMAL CLONIDINE FOR SMOKING CESSATION

OBJECTIVE: To determine the efficacy and safety of clonidine versus pl acebo in smoking cessation. DESIGN: Single-center, randomized, double- blind, parallel-design comparison of transdermal clonidine with behavi or modification, transdermal clonidine without behavior modification, placebo with behavior modification, and placebo without behavior modif ication. SETTING: Outpatient, university-based ambulatory care facilit y. PATIENTS: One hundred fifty generally healthy, highly nicotine-depe ndent cigarette smokers. INTERVENTION: Clonidine was given as the tran sdermal patch initiated 72 hours prior to smoking-cessation attempts a nd continued for six weeks thereafter. Clonidine was given at a dose o f 0.2 mg/d for patients weighing more than 150 pounds (>67.5 kg) and a t a dose of 0.1 mg/d for patients weighing less than 150 pounds (<67.5 kg). Behavior modification consisted of a total of 12 one-hour struct ured group training sessions. Patients not receiving behavior modifica tion received printed material, which included the ''Help Quit Kit'' a nd the ''I Quit Kit'' from the American Cancer Society. MAIN OUTCOME M EASURES: Smoking-cessation rates were assessed at 6, 12, 24, and 52 we eks of follow-up. In addition, adverse reactions to clonidine or place bo were evaluated. RESULTS: Clonidine with behavior modification was s tatistically superior to the other three treatment groups but only at 6 weeks of follow-up. There were no differences in smoking-cessation r ates among any of the treatment groups at any other follow-up interval s. Patients receiving behavior modification, regardless of whether the y received clonidine, had better quit rates than patients not receivin g behavior modification at all follow-up times except 52 weeks. Women receiving clonidine had significantly better quit rates than men recei ving clonidine at all follow-up visits. Clonidine was associated with a significantly higher incidence of adverse effects than placebo (52 v s. 11 percent). However, the number of smokers withdrawing from the st udy was not greater with clonidine compared with placebo (9 vs. 7 perc ent, respectively). CONCLUSIONS: Clonidine is probably not effective a s a pharmacologic adjunct to behavior modification in smoking cessatio n. It may have a potential role in women smokers who do not respond to or cannot tolerate more traditional smoking-cessation therapies.