Effects of Contingency Management and Nicotine Replacement Therapy on Youth Smoking
Condition: Cigarette Smoking Behavior
Study type: Interventional
Phase: Phase 1

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.
    

Detailed 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.
    

Intervention name(s): Nicotine polacrilex
Intervention type(s): Drug
Intervention description(s): Participants will apply Nicoderm (14 mg) patches everyday during this study.
Other intervention name(s): Nicoderm (14 mg)
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science