Effects of Contingency Management and Nicotine Replacement Therapy on Youth Smoking

Nicotine dependence typically emerges during adolescence. As almost 90% of adult smokers begin during adolescence (Campaign for Tobacco Free Kids, 2008), it is critical to develop effective treatments for reducing smoking in adolescents. Despite substantial research in adults, relatively little effort has focused on treatments to reduce adolescent smoking.

Current treatment options for adolescent smoking can be broadly categorized into behavioral and pharmacological approaches. Behavioral treatments, such contingency management, reduce adolescent smoking significantly more than control conditions (Grim Shaw and Stanton, 2006; Sussman et al., 2006). Notably, pharmacotherapies, such as nicotine replacement therapy (NRT) are also safe and efficacious in reducing smoking in adolescents (Upadhyaya et al., 2004; Killen et al., 2004; Hurt et al., 2000; Smith et al., 1996). However, there is limited knowledge regarding the combination of behavioral interventions with pharmacotherapies for reducing adolescent smoking (Hanson et al., 2003; Mollohan et al., 2005).

Combinations of behavioral and pharmacological treatments are more efficacious and cost-effective in reducing smoking in adults than either approach alone (Roving et al., 2009; Reus and Smith, 2008; see review in Ingersoll \& Cohen's, 2005). For example, combined treatment with nicotine patches and an "Progressive-Reinforcement Reset" contingency management (CM) paradigm (smokers received escalating monetary rewards according to duration of abstinence) increased abstinence from smoking significantly more than nicotine replacement therapy alone in adults (Shoptaw et al., 2002). Such combination therapy could also be more effective in reducing adolescent smoking than individual treatments. Research efforts in this regard have been hindered, in part, by the expense and complexity of outpatient trials and the relative dearth of a less expensive laboratory procedure assessing adolescent smoking.

Developing and validating a laboratory procedure to evaluate the combined effects of CM and pharmacological adjuncts for adolescent smoking is important because human laboratory studies can be conducted more rapidly and efficiently than clinical trials. Randomized, placebo-controlled clinical trials tend to be costly, lengthy and labor-intensive, and should be reserved for only the most promising medications that show at least some level of efficacy in enhancing CM effectiveness in controlled laboratory conditions. Laboratory studies using adolescent smokers might also identify the optimal conditions (e.g., dose, duration of treatment) under which pharmacotherapies might be expected to be synergistic with CM.

This proposal has one specific aim: to evaluate combined effects of CM and NRT treatments for assessing smoking in adolescents. Such a laboratory paradigm could be useful in evaluating potential pharmacotherapies in augmenting the effects of CM in adolescent smokers. We propose to conduct a proof-of-concept study in which 60 adolescent smokers (ages 13-21) will participate in a randomized, placebo-controlled, double-blind, between-groups, 2-week laboratory study. After intake screening, eligible adolescent smokers will be randomly assigned to one of the following four groups: CM+nicotine patches, CM+placebo patches, noncontingent control (NC)+nicotine patches and NC+placebo patches. Fifteen participants will be enrolled in each of the four groups, totaling 60 participants. Participants will be asked to wear one patch daily for the duration of the study. On day 1, participants will arrive to the laboratory for a 1-h session. During this session, breath carbon monoxide (CO) levels, saliva or urinary cotinine levels will be evaluated. Participants will also complete questionnaires on craving, withdrawal and cigarette dependence. Participants will then receive seven patches, to wear for seven days, one patch daily, beginning that day. Everyday between days 8 to 12, participants will arrive to the laboratory for one hour each, and at the end of the session, they will apply a new patch. Five sessions during the days 8 to 12 will serve as CM or noncontingent sessions. On these sessions, breath CO levels, saliva or urinary cotinine levels will be evaluated, and participants will complete questionnaires on craving, withdrawal and cigarette dependence. On these sessions, participants will have opportunity to receive payments based on their CO levels, according to the group assignment. If successful, the proposed study will provide a human laboratory model for use in studies of the combined CM and pharmacological approaches for modifying adolescent smoking behavior.