Effects of Contingency Management and Nicotine Replacement Therapy on Youth Smoking

Cigarette Smoking Behavior Clinical Trial

Official title: Effects of Contingency Management and Nicotine Replacement Therapy on Youth Smoking

Status Completed

Clinical Trial Summary

Cigarette smoking is an important public health concern, and it is most often initiated in adolescence. Despite substantial research on smoking cessation in adults, however, relatively little effort has focused on therapeutic approaches to reduce adolescent smoking.

Behavioral interventions, such as contingency management (CM), and pharmacotherapies, such as nicotine replacement therapy (NRT), each have some efficacy in reducing adolescent smoking, and in adults, combination of behavioral and pharmacological approaches is more effective in reducing smoking than either one alone. Little is known about combining these therapeutic approaches in adolescent smokers, and research in this area has been hindered, in part, by the expense and complexity of large-scale clinical trials of the combined treatments and the relative dearth of a cost-effective laboratory procedure. Developing and validating a laboratory model to evaluate the combined effects of CM and pharmacological adjuncts for adolescent smoking is important because such studies can be conducted more rapidly and efficiently, and could provide information on the optimal conditions (e.g., dose) under which pharmacotherapies might augment the positive effects of CM.

The investigators propose to conduct a randomized, placebo-controlled, double-blind, between-groups, 2-week laboratory study. Participants 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. 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. Five sessions during the days 8 to 12 will serve as CM or noncontingent sessions, and participants will continue wearing patch daily. On these sessions, breath CO levels will be evaluated, and 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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cigarette Smoking Behavior

• NCT number: NCT01359709
• Study type: Interventional
• Source: University of California, Los Angeles
• Status: Completed
• Phase: Phase 1
• Start date: June 2011
• Completion date: January 2016